Table 1.
Disposition of participants
| KB003 (n=78) |
Placebo (n=82) |
|
|---|---|---|
| Full Analysis Set * | 74 (94.9) | 76 (92.7) |
| Safety Set† | 78 (100.0) | 82 (100.0) |
| Evaluable Set‡ | 64 (82.1) | 65 (79.3) |
| Received all 7 doses of study drug | 56 (71.8) | 51 (62.2) |
| Completed all study visits including week 32 visit | 57 (73.1) | 54 (65.9) |
| Discontinued the study early | 14 (17.9) | 18 (22.0) |
| Primary reason for early study discontinuation | ||
| Adverse event | 1 (7.1) | 2 (11.1) |
| Non-compliance/lost to follow-up | 2 (14.3) | 1 (5.6) |
| Pregnancy | 0 | 0 |
| Protocol deviation | 6 (42.9) | 10 (55.6) |
| Consent withdrawal | 5 (35.7) | 4 (22.2) |
| Death | 0 | 0 |
| Investigator withdrew participation from study | 0 | 1 (5.6) |
Percentages for primary reason for early study discontinuation are based on the number of discontinued participants in each treatment group. All other percentages are based on the number of randomised participants in each treatment group.
*The Full Analysis Set consisted of all randomised participants with a baseline value who received at least 1 dose of study drug and had at least 1 treatment period measurement.
†The Safety Set consisted of all randomised participants who received at least 1 dose of study drug.
‡The Evaluable Set consisted of all participants included in the Full Analysis Set who received at least 4 consecutive doses of study drug and had no major protocol deviations.