Table 4.
Safety outcomes
| Adaptive pacing therapy (n=159) | Cognitive behaviour therapy (n=161) | Graded exercise therapy (n=160) | Specialist medical care alone (n=160) | ||
|---|---|---|---|---|---|
| Non-serious adverse events | 949 | 848 | 992 | 977 | |
| Participants with non-serious adverse events | 152 (96%) | 143 (89%) | 149 (93%) | 149 (93%) | |
| Non-serious adverse events per 100 person-years | 597 (559–636) | 527 (492–563) | 620 (582–660) | 611 (573–650) | |
| Serious adverse events | 16 | 8 | 17 | 7 | |
| Participants with serious adverse events | 15 (9%) | 7 (4%) | 13 (8%) | 7 (4%) | |
| Serious adverse events per 100 person-years | 10·1 (5·8–16·3) | 5·0 (2·2–9·8) | 10·6 (6·2–17·0) | 4·4 (1·8–9·0) | |
| Serious adverse reactions | 2 | 4 | 2 | 2 | |
| Participants with serious adverse reactions | 2 (1%) | 3 (2%) | 2 (1%) | 2 (1%) | |
| Serious adverse reactions per 100 person-years | 1·3 (0·2–4·5) | 2·5 (0·7–6·4) | 1·3 (0·2–4·5) | 1·3 (0·2–4·5) | |
| Serious deterioration (composite)* | 13 (8%) | 14 (9%) | 10 (6%) | 15 (9%) | |
| Physical functioning reduction | 7 (4%) | 5 (3%) | 5 (3%) | 6 (4%) | |
| PCGI worse | 5 (3%) | 7 (4%) | 1 (<1%) | 10 (6%) | |
| Withdrawn due to worsening | 3 (2%) | 0 | 2 (1%) | 1 (<1%) | |
| Serious adverse reactions | 2 (1%) | 3 (2%) | 2 (1%) | 2 (1%) | |
| Differences in serious deterioration | |||||
| Comparison with specialist medical care | −1·2%; p=0·71 | −0·7%; p=0·83 | −3·1%; p=0·30 | .. | |
| Comparison with adaptive pacing therapy | .. | 0·5%; p=0·87 | −1·9%; p=0·51 | .. | |
Data are n, n (%), or rate (95% CI), unless otherwise stated. Adverse events were considered serious when they involved death, hospital admission, increased severe and persistent disability, self-harm, were life-threatening, or required an intervention to prevent one of these. There were no suspected unexpected serious adverse reactions. PCGI=participant-rated clinical global impression.
Serious deterioration composite is either of a short form-36 physical function subscale score reduction at two consecutive visits, a PCGI score of much worse or very much worse at two consecutive visits, withdrawal from treatment due to explicit worsening, or a serious adverse reaction; the numbers withdrawn from treatment due to worsening is a subset of all those withdrawing from treatment shown in table 2.