Summary of patient disposition: all enrolled patients
| F-F-F n (%) | F-RP-F n (%) | RP-F-F n (%) | RP-RP-F n (%) | Total n (%) | |
|---|---|---|---|---|---|
| Patients with study drug administered | 216 (100) | 108 (100) | 108 (100) | 213 (100) | 645 (100) |
| Period 2 | F-F | F-RP | RP-F | RP-RP | Total |
| Patients completed Period 2 | 189 (87.5) | 100 (92.6) | 93 (86.1) | 190 (89.2) | 572 (88.7) |
| Patients discontinued from Period 2 | 27 (12.5) | 8 (7.4) | 15 (13.9) | 23 (10.8) | 73 (11.3) |
| Primary reason for premature DC* | |||||
| Adverse event | 8 (3.7) | 0 | 3 (2.8) | 7 (3.3) | 18 (2.8) |
| Screen failure† | 1 (0.5) | 0 | 1 (0.9) | 0 | 2 (0.3) |
| Withdrawal of consent | 9 (4.2) | 1 (0.9) | 3 (2.8) | 4 (1.9) | 17 (2.6) |
| Other‡ | 9 (4.2) | 7 (6.5) | 8 (7.4) | 12 (5.6) | 36 (5.6) |
| Period 3 | F-F-F | F-RP-F | RP-F-F | RP-RP-F | |
| Patients completed Period 3§ | 174 (92.1) | 88 (88.0) | 81 (87.1) | 172 (90.5) | 515 (90.0) |
| Patients discontinued from Period 3‡ | 15 (7.9) | 12 (12.0) | 12 (12.9) | 18 (9.5) | 57 (10.0) |
| Primary reason for DC§ | |||||
| Adverse event | 3 (1.6) | 5 (5.0) | 4 (4.3) | 11 (5.8) | 23 (4.0) |
| Medical Reason | 0 | 1 (1.0) | 0 | 0 | 1 (0.2) |
| Pregnancy | 0 | 0 | 1 (1.1) | 0 | 1 (0.2) |
| Withdrawal of consent | 7 (3.7) | 4 (4.0) | 0 | 3 (1.6) | 14 (2.4) |
| Other‡ | 5 (2.6) | 2 (2.0) | 7 (7.5) | 4 (2.1) | 18 (3.1) |
Percentages based on the number of randomised patients, unless otherwise specified.
*Percentages for discontinuation reasons based on the total number of patients per group.
†Patients were identified as ineligible after starting study drug administration.
‡The category ‘other’ encompassed several different causes of patient discontinuation, the most common being noncompliance with study visits, positive or indeterminate QuantiFERON tests, and study drug being interrupted for >4 weeks.
§Percentages for completion or discontinuation based on total number of patients who completed Period 2.
DC, discontinuation; F, FKB327; n, total number of patients with observation; RP, reference product.