Table B.
Variation of non-serious adverse events and baseline variables by centre (N %)
| A | B | C | D | E | F | P value | |
|---|---|---|---|---|---|---|---|
| Median (quartiles) NSAE count | 3 (1, 4) | 3 (2, 5) | 4 (2, 6) | 7 (4, 10) | 8 (4, 13) | 10 (6, 15) | < .001* |
| NSAE ≤ 4 (313) | 86 (78) | 74 (69) | 78 (58%) | 38 (34) | 32 (29) | 5 (8) | |
| NSAE > 4 (327) | 24 (22) | 34 (31) | 57 (42%) | 75 (66) | 79 (71) | 58 (92) | < .0001# |
| Chalder fatigue | 28.5 (3.6)¶ | 28.1 (3.4) | 27.2 (4.1) | 28.8 (3.6) | 28.0 (3.9) | 29.2 (3.5) | .005$ |
| SF36 PF | 39 (16) | 40 (16) | 41 (13) | 36 (16) | 35 (16) | 37 (16) | .006 |
| CFS symptoms | 5.0 (1.7) | 4.6 (1.7) | 4.3 (1.8) | 4.6 (1.8) | 4.7 (1.8) | 5.4 (1.8) | .01 |
| HADS anxiety | 7.7 (4.4) | 7.3 (3.7) | 8.1 (4.6) | 7.9 (4.2) | 8.4 (4.2) | 9.3 (3.8) | .008 |
| HADS depression | 8.3 (3.5) | 7.6 (3.2) | 8.2 (3.8) | 8.4 (4.0) | 8.4 (4.0) | 9.4 (4.2) | .02 |
| PHQ-15 | 14.4 (3.9) | 13.8 (4.3) | 12.9 (4.4) | 14.2 (4.2) | 14.8 (5.2) | 15.7 (5.5) | < .001 |
| BMI | 25.2 (4.7) | 27.0 (5.5) | 24.0 (5.5) | 25.5 (4.7) | 25.1 (5.0) | 27.2 (5.3) | .04 |
*Kruskal–Wallis. #χ2 (5 df) = 129.4, P < .0001. NSAE = non-serious adverse events. SF36 PF = SF36 physical function sub-scale score. HADS = Hospital Anxiety Depression Scale. PHQ-15 = Patient Health Questionnaire. ¶Last seven lines show means (SD). $The comparisons were by one way ANOVA across the centre strata of low, medium and high NSAE counts, with linear test for trend.