Table 9.
Clinical response rates at TOC relative to baseline local and systemic findings
| System level | Clinical finding | Comparison of patients at BL and TOCa |
|||
|---|---|---|---|---|---|
| JNJ-Q2 |
Linezolid |
||||
| BL (n/N) | Cure rate (n′/n) at TOC (%) | BL (n/N) | Cure rate (n′/n) at TOC (%) | ||
| Local signsb | 3/5 | 23/83 | 12/23 (52.2) | 28/78 | 18/28 (64.3) |
| 4/5 | 39/83 | 26/39 (66.7) | 35/78 | 19/35 (54.3) | |
| 5/5 | 21/83 | 17/21 (81.0) | 15/78 | 11/15 (73.3) | |
| Systemicc | Fever | 4/83 | 3/4 (75.0) | 3/78 | 2/3 (66.7) |
| WBC > 10,000 | 22/83 | 13/22 (59.1) | 26/78 | 15/26 (57.7) | |
| Lymphatic involvementd | 70/83 | 48/70 (68.6) | 64/78 | 40/64 (62.5) | |
| Elevated CRP | 68/83 | 44/68 (64.7) | 63/78 | 37/63 (58.7) | |
| Two systemic findings | 45/83 | 30/45 (66.7) | 39/78 | 23/39 (59.0) | |
| Three systemic findings | 14/83 | 9/14 (64.3) | 17/78 | 10/17 (58.8) | |
Percentages are based on the number of patients in each treatment group (JNJ-Q2, 83 patients; linezolid, 78 patients). BL, baseline rate. N, number of randomized patients for that treatment arm; n, number of patients with that particular finding; n′, number of patients with a clinical cure at TOC.
Patients had to have at least 3 of the following five signs: purulent drainage/discharge; erythema with/without induration; fluctuation; heat/localized warmth; pain/tenderness.
Patients had to have at least one systemic manifestation to enter the study. Leukopenia, hypothermia, and >15% band forms were all part of systemic findings in the inclusion criteria; however, no subject who was randomized into the study exhibited any of those findings. Elevated CRP was not part of the inclusion criteria, but CRP was included as another manifestation of systemic findings.
Lymphatic involvement included evidence of either lymphangitis or lymphadenopathy graded on a point scale from 0 to 4, with 0 indicating no lymphatic involvement.