Table 3.
Variable | European Union Trial | U.S. Trial | ||
---|---|---|---|---|
Afamelanotide | Placebo | Afamelanotide | Placebo | |
Days recorded in diary — no. | 9742 | 9601 | 8055 | 7368 |
Pain level — no. of days (% of recorded days) | ||||
No pain, Likert score of 0 | 8914 (92)† | 8463 (88) | 7156 (89)† | 6245 (85) |
Mild pain, Likert score of 1–3 | 687 (7) | 777 (8) | 753 (9) | 840 (11) |
Moderate pain, Likert score of 4–6 | 124 (1) | 298 (3) | 127 (2) | 239 (3) |
Severe pain, Likert score of 7–10 | 17 (<1) | 63 (<1) | 19 (<1) | 44 (<1) |
The difference in the distribution of pain scores between study-drug groups was analyzed by means of the chi-square test.
P<0.001 for the comparison with placebo.