A | LT50 Median (IC95%) in days | P | |||||||
---|---|---|---|---|---|---|---|---|---|
Regimen | Placebo | 18 mg | 36 mg | 72 mg | Pl vs 18/36 | 18 vs 36 | 36 vs 72 | 6 h vs 24 h | Sp-Fr vs Ja-Hu |
Spain | |||||||||
1-6 h | 3.5 [3-5] | 5 [3-7] | 6 [5-8] | ND | <0.001 | <0.001 | ND | NS except for 72 mg | |
24 h | 3 [3-6] | 4.5 [3-6] | 5 [3-6] | ND | <0.001 | NS | ND | <0.001 | |
France | <0.001 | ||||||||
1-6 h | 3 [3-5] | 5 [4-7] | 5.5 [4-7] | ND | <0.001 | NS | ND | NS except for 36 mg | |
24 h | 3 [3-5] | 3 [2-4] | 5 [4-8] | ND | NS | <0.001 | ND | <0.001 | |
Japan | |||||||||
1-6 h | 4 [3-5] | ND | 6.5 [5-9] | 7 [5-9] | <0.001 | ND | NS | NS | |
24 h | 4 [3-5] | ND | 5.5 [4-8] | 6 [4-8] | <0.001 | ND | NS | ||
<0.001 | |||||||||
Hungary | |||||||||
1-6 h | 3 [3-5] | ND | 5 [4-8] | 6 [5-10] | <0.001 | ND | NS | NS | |
24 h | 4 [3-5] | ND | 5 [4-8] | 6 [4-9] | <0.001 | ND | NS | ||
Total | |||||||||
1-6 h | 3 [3-5] | 5 [3-7] | 5.5 [4-9] | 6.5 [5-10] | <0.001 | NS | <0.001 | NS | ND |
24 h | 3.5 [3-5] | 4 [2-6] | 5 [3-8] | 6 [4-9] | <0.001 | <0.001 | <0.001 | ND | |
OP50 | 6 [6-7] | ||||||||
B | LT100 Median (IC95%) in days | P | |||||||
Regimen | Placebo | 18 mg | 36 mg | 72 mg | Pl vs 18/36 | 18 vs 36 | 36 vs 72 | 6 h vs 24 h | Sp-Fr vs Ja-Hu |
Spain | |||||||||
1-6 h | 8.5 [7-8] | 10 [9-10] | 11.5 [11-12] | ND | <0.001 | <0.001 | ND | NS except for 72 mg | <0.001 |
24 h | 7 [6-8] | 9 [8-10] | 9.5 [9-10] | ND | <0.001 | NS | ND | <0.001 | |
France | |||||||||
1-6 h | 7 [6-8] | 10 [9-11] | 11 [10-12] | ND | <0.001 | NS | ND | NS except for 36 mg | |
24 h | 7 [6-8] | 8 [7-9] | 10.5 [10-11] | ND | NS | <0.001 | ND | <0.001 | |
Japan | <0.001 | ||||||||
1-6 h | 8 [7-8] | ND | 12.5 [12-13] | 13 [12-14] | <0.001 | ND | NS | NS | |
24 h | 7.5 [7-8] | ND | 11 [10-12] | 12 [11-13] | <0.001 | ND | NS | ||
Hungary | |||||||||
1-6 h | 7 [6-8] | ND | 12 [11-13] | 12.5 [12-13] | <0.001 | ND | NS | NS | |
24 h | 8 [7-8] | ND | 11 [10-12] | 11.5 [11-12] | <0.001 | ND | NS | ||
Total | |||||||||
1-6 h | 7 [6-8] | 5 [3-7] | 5.5 [4-9] | 6.5 [5-10] | <0.001 | NS | <0.001 | NS | ND |
24 h | 8 [7-8] | 4 [2-6] | 5 [3-8] | 6 [4-9] | <0.001 | <0.001 | <0.001 | ND | |
OP50 | 14 [13-15] |