Table 3.
Subject disposition and diagnosis
| Group or diagnosis | No. of patients (%) in groupa |
||
|---|---|---|---|
| JNJ-Q2b (n = 83) | Linezolidc (n = 78) | Total (n = 161) | |
| ITT set | 83 (100.0) | 78 (100.0) | 161 (100) |
| mITT set | 62 (74.7) | 59 (75.6) | 121 (75.2) |
| CE set | 53 (63.9) | 49 (62.8) | 102 (63.4) |
| ME set | 53 (63.9) | 49 (62.8) | 102 (63.4) |
| Completed study through SFU visit | 77 (92.8) | 73 (93.6) | 150 (93.2) |
| Completed study through LFU visit | 66 (79.5) | 71 (91.0) | 137 (85.1) |
| Discontinuted before SFU visit | 6 (7.2) | 5 (6.4) | 11 (6.8) |
| Discontinued before LFU visit | 15 (18.1) | 6 (7.7) | 21 (13.0) |
| Completed SFU visit but discontinued before LFU visit | 9 (10.8) | 1 (1.3) | 10 (6.2) |
| Primary reason for discontinuation before SFU visitd | |||
| Adverse event | 2 (2.4) | 2 (2.6) | 4 (2.5) |
| Lost to follow-up | 1 (1.2) | 1 (1.3) | 2 (1.2) |
| Voluntarily withdrew | 2 (2.4) | 1 (1.3) | 3 (1.9) |
| Physician decision | 0 | 1 (1.3) | 1 (0.6) |
| Sponsor decision | 1 (1.2) | 0 | 1 (0.6) |
| Primary reason for discontinuation after SFU visite | |||
| Lost to follow-up | 9 (10.8) | 1 (1.3) | 10 (6.2) |
| Diagnosis at baseline | |||
| Wound infection | 30 (36.1) | 23 (29.5) | 53 (32.9) |
| Abscess | 25 (30.1) | 28 (35.9) | 53 (32.9) |
| Cellulitis | 28 (33.7) | 27 (34.6) | 55 (34.2) |
a
Percentages are based on the number of randomized patients in each treatment group unless otherwise specified. Completed and discontinued categories are not mutually exclusive.
b
JNJ-Q2 was administered at 250 mg twice daily.
c
Linezolid was administered at 600 mg twice daily.
d
Percentages are based on the number of patients who discontinued before the SFU visit.
e
Percentages are based on the number of patients who completed the SFU visit but discontinued before the LFU visit.