Table 1

 Characteristics of and time to adverse effect reporting in randomised controlled trials of cyclo-oxygenase-2 and tumour necrosis factor α inhibitors

COX-2 (26 studies)TNFα (44 studies)Total (70 studies)
AE, adverse effect; COX-2, cyclo-oxygenase-2; RCT, randomised controlled trial; SAE, serious/severe adverse event; SEER, surveillance, epidemiology and end-results; SIR, standardised incidence ratio; TNF, tumour necrosis factor.
Number of patients enrolled
    Mean1541251
    Median602112
    Range67–807620–1049
Duration of RCT
    Mean number of weeks1243
    Median624
    Range4–1562–52
n (%) n (%) n (%)
AEs (n and % reported)19 (73)36 (82)55 (79)
Table given for AEs21 (81)34 (77)55 (79)
Time to AEs reported (including SAE)6 (23)17 (39)23 (33)
Time to SAEs reported3 (12)16 (36)19 (27)
Time reported for ⩽50% of SAEs3 (12)9 (20)12 (17)
Time reported for >50% of SAEs000
Time reported for all SAEs07 (16)7 (10)
SIR based on annual SEER figures08 (18)8 (11)
Patient years as time frame2 (8)4 (9)6 (9)