Quality of reporting of harms in in RA and axSpA; 9 Items based on CONSORT Extension for Reporting Harms Outcomes [3]
| RA (N=41)N (%) | axSpA (N=23)N (%) | |
|---|---|---|
| Any information on harms (1 and/or 2 and/or 3 and/or 4) | 34 (83) | 15 (65) |
| Studies meeting sufficient quality of reporting of harms (2a & 3b & 3c) | 10 (24) | 2 (9) |
| 1. Harms-related information in title, abstract or introduction section(s) (1-2) | 25 (68) | 9 (39) |
| 2. Harms-related information in methods section (3-5)a Data collection on harms on the basis of active surveillance (4) | 16 (39)12 (29) | 4 (17)3 (13) |
| 3. Harms-related information in results section (6-8)a Withdrawals due to AEs or health-related reasons (6)b Number of participants with AEs and number of AEs (7)c Nature of observed harms (8)d Details on observed AEs: severity, timing and/or duration (8)e The results section reports on what the method section promises (8) | 28 (68)22 (54)15 (37)22 (54)8 (20)6 (15) | 9 (39)9 (39)6 (26)5 (22)2 (9)1 (4) |
| 4. Harms-related information in discussion section (10) | 23 (56) | 8 (35) |