Table 5.
Safety outcomes
| GES group (n=97) | Control group (n=101) | Difference between groups | ||
|---|---|---|---|---|
| Participants reporting non-serious adverse events | 27 (28%) | 23 (23%) | χ2=0·67; p=0·41 | |
| Serious adverse events | 1 (1%) | 2 (2%) | .. | |
| Serious adverse reactions | 0 | 0 | .. | |
| Serious deterioration | ||||
| Composite* | 20 (21%) | 30 (30%) | χ2=2·2; p=0·14 | |
| Physical functioning reduction* | 20 (21%) | 25 (25%) | χ2=0·48; p=0·49 | |
| Worsened CGI-health | 1 (1%) | 8 (8%) | p=0·04† | |
| Worsened CGI-CFS | 0 | 9 (9%) | p=0·003† | |
| Withdrawal due to worsening | 0 | 0 | .. | |
Data are number of participants reporting these events. Data are n (%) unless otherwise stated. No unexpected serious adverse reactions were suspected. GES=guided graded exercise self-help. CFS=chronic fatigue syndrome. CGI=clinical global impression. SF-36 PF=Short-Form 36 physical function subscale.
*
Reduction in SF-36 PF score by ≥10 points, scores of “much worse” or “very much worse” on participant-rated CGI-health, or active withdrawal due to worsening.
†
Fisher's exact test.