Table 1.
Baseline characteristics
| Factor | All patients (N = 79) |
Placebo + BSC (n = 26) |
Siltuximab + BSC (n = 53) |
P * |
|---|---|---|---|---|
| Hemoglobin normal at baseline (defined as ≤LLN, range 11-14 g/dL) | 37/79 (47) | 15/26 (58) | 22/53 (42) | .175 |
| CRP normal at baseline (defined as ≤ULN, ≤4 mg/L) | 37/79 (47) | 16/26 (62) | 21/53 (40) | .066 |
| IgG normal at baseline (defined as ≤ULN, ≤17.65 g/L) | 43/79 (54) | 15/26 (58) | 28/53 (53) | .683 |
| Fibrinogen normal at baseline (defined as ≤ULN, ≤4 μmol/L) | 30/79 (38) | 12/26 (46) | 18/53 (34) | .297 |
| Albumin normal at baseline (defined as ≥LLN, range 32-40 g/L) | 44/79 (56) | 16/26 (62) | 28/53 (53) | .463 |
| Platelets normal at baseline (defined as ≤ULN, range 300-500 × 109/L) | 55/79 (70) | 19/26 (73) | 36/53 (68) | .638 |
| 34-point disease score ≥7 | 40/79 (51) | 17/26 (65) | 23/53 (43) | .065 |
| SPD at baseline <1400 mm2 | 37/74 (50) | 17/25 (68) | 20/49 (41) | .026 |
| Best response (DTSyR) of ≥PR (postbaseline) | 18/79 (23) | 0/26 (0) | 18/53 (34) | NA |
Data given as n/N (%), where n indicates number with factor and N indicates number with valid data for factor. Bold font indicates significance.
BSC, best supportive care; DTsyR, durable tumor and systematic response; LLN, lower limit of normal; NA, not applicable; PR, partial response.
*
P values represent comparison between groups, not against the overall population.