Table 6

 Patient characteristics, overall treatment response, and treatment effectiveness at the time of adverse events by highest reported seriousness*

VariableSerious (n = 76)Non-serious (n = 214)No event (n = 779)All patients (n = 1073)
Values are n (%) unless stated otherwise.
*Seriousness was missing in reports of four patients.
†Treatment response as defined by the EULAR criteria, in relation to disease activity at start of etanercept treatment.
‡Disease activity score for the 28-joint indices (DAS 28).
    Female59 (77.6%)173 (80.8%)587 (75.4%)822 (76.6%)
Age (years)
    Mean55.450.952.052.0
    Median55.5525353
    Interquartile range48.5 to 6642 to 5944 to 6144 to 61
Overall treatment response†
    No response3 (4.0%)18 (8.4%)56 (7.2%)77 (7.25)
    Moderate response33 (43.4%)66 (30.8%)237 (30.4%)338 (31.5%)
    Good response26 (34.2%)94 (43.9%)328 (42.1%)449 (41.9%)
    Missing14 (18.4%)36 (16.8%)158 (20.3%)209 (19.5%)
Latency to adverse event (months)
    Mean15.15.9
    Median14.53.0
    Interquartile range4.3 to 26.41.2 to 6.2
Disease activity when adverse event occurred‡
    Inactive disease16 (21.1%)25 (11.7%)
    Low activity3 (4.0%)15 (7.0%)
    Intermediate activity33 (43.4%)104 (48.6%)
    High activity23 (30.3%)58 (27.1%)
    Missing1 (1.3%)12 (5.6%)
Response when adverse event occurred†
    No response8 (10.5%)32 (15.0%)
    Moderate response34 (44.7%)99 (46.3%)
    Good response16 (21.1%)36 (16.8%)
    Missing18 (23.7%)47 (22.0%)
Methotrexate when adverse event occurred†17 (22.4%)73 (34.1%)
    Missing5 (6.6%)3 (1.4%)