Table 2. Mean Change in ADPS From Baseline at Week 13 (Full Analysis Set)a.
Stage 1 hypothesis | P value | w1 | Stage 2 hypothesis | P value | w2 | Combined P value |
---|---|---|---|---|---|---|
HSK16149 study dose, 40 mg/d | ||||||
H1234: p1234,1 | .60 | 0.58 | H1234: p12,2 | <.001 | 0.81 | <.001 |
H123: p123,1 | .54 | 0.58 | H123: p12,2 | <.001 | 0.81 | <.001 |
H124: p124,1 | .54 | 0.58 | H124: p12,2 | <.001 | 0.81 | <.001 |
H134: p134,1 | .54 | 0.58 | H134: p1,2 | <.001 | 0.81 | <.001 |
H12: p12,1 | .45 | 0.58 | H12: p12,2 | <.001 | 0.81 | <.001 |
H13: p13,1 | .45 | 0.58 | H13: p1,2 | <.001 | 0.81 | <.001 |
H14: p14,1 | .45 | 0.58 | H14: p1,2 | <.001 | 0.81 | <.001 |
H1: p1,1 | .31 | 0.58 | H1: p1,2 | <.001 | 0.81 | <.001 |
HSK16149 study dose, 80 mg/d | ||||||
H1234: p1234,1 | .60 | 0.58 | H1234: p12,2 | <.001 | 0.81 | <.001 |
H123: p123,1 | .54 | 0.58 | H123: p12,2 | <.001 | 0.81 | <.001 |
H124: p124,1 | .54 | 0.58 | H124: p12,2 | <.001 | 0.81 | <.001 |
H234: p234,1 | .70 | 0.58 | H234: p2,2 | <.001 | 0.81 | <.001 |
H12: p12,1 | .45 | 0.58 | H12: p12,2 | <.001 | 0.81 | <.001 |
H23: p23,1 | .62 | 0.58 | H23: p2,2 | <.001 | 0.81 | <.001 |
H24: p24,1 | .61 | 0.58 | H24: p2,2 | <.001 | 0.81 | <.001 |
H2: p2,1 | .51 | 0.58 | H2: p2,2 | <.001 | 0.81 | <.001 |
Abbreviation: ADPS, average daily pain score.
Missing week 13 ADPSs were calculated based on multiple fill (multiple imputation) for filling. H is statistical hypothesis test; p is the P value of test H; wj (j = 1 or 2) is the weight of the first and second stages given in advance, satisfying 0 ≤ wj ≤ 1 and w12 + w22 = 1 (w12 + w22 = 1: w12 plus w22 is equal to 1).