Table 2.
Characteristics of DBPCFC positive and DBPCFC negative subjects
| DBPCFC negative (n) |
DBPCFC positive (n) |
differences with α = 5% between groups |
|
|---|---|---|---|
| Number of subjects | 56 (40.6%) | 82 (59.4%) | |
| Maximum soy challenge meal level 9 applied | 53 (94.6% [85.4; 98.2]) | 51 (62.2% [51.4; 71.9]) | Significant |
| Maximum placebo challenge meal level 9 applied | 48 (85.7%[74.3; 92.6]) |
77 (93.9% [86.5; 97.4]) |
n.s. |
| Objective signs (O1-10) at soy challenge meal (in n patients) |
5 (8.9% [3.9; 19.3]) |
58 (70.7% [61.4; 80.5]) |
Significant |
| Subjective symptoms (S1–8) at soy challenge meal (single type or sum type) |
20 (35.7% [24.5; 48.8]) |
70 (85.4% [76.1; 91.4]) |
Significant |
| Major placebo reactions objective typea | 19 (33.9% [24.5; 48.8]) |
0 (0% [0; 4.5]) |
Significant |
| Major placebo reactions subjective typea | 27 (48.2% [35.7; 61.0]) |
10 (12.2% [6.8; 21.0]) |
Significant |
Maximum dose levels applied and occurrence of objective signs, subjective symptoms and major placebo reactions in DBPCFC positive and DBPCFC negative patients at soy and placebo challenge meals. 95% confidence intervals are given (per cent based on the number of patients per group; in case of non-overlapping confidence intervals significant differences with α = 5% between populations exist)
n.s. not significant
aFor definition of Major placebo reactions see Table 1