Table 5

Number of patients with one or more malignancies through week 160 compared with the expected number of malignancies from the general US population according to the SEER database

Golimumab
Placebo*50 mg100 mgCombined
Treated patients in the study§155279328431
Type of malignancy
Lymphoma
 Patient-years of follow-up
 Total58302560863
 Median0.30.81.72.4
 Observed/expected** number of patients with event0/0.020/0.114/0.204/0.30
 SIR†† (95% CI‡‡)0.00 (0.00 to 149.04)0.00 (0.00 to 28.04)20.37 (5.55 to 52.15)13.19 (3.59 to 33.78)
Other malignancies
 Patient-years of follow-up
 Total57302560863
 Median0.30.81.72.4
 Observed/expected** number of patients with event1/0.452/2.442/4.404/6.84
 SIR†† (95% CI‡‡)2.24 (0.06 to 12.50)0.82 (0.10 to 2.96)0.45 (0.06 to 1.64)0.58 (0.16 to 1.50)
All malignancies
 Patient-years of follow-up
 Total57302560862
 Median0.30.81.72.4
 Observed/expected** number of patients with event1/0.462/2.546/4.588/7.12
 SIR†† (95% CI‡‡)2.15 (0.05 to 12.00)0.79 (0.10 to 2.84)1.31 (0.48 to 2.85)1.12 (0.49 to 2.21)
  • * Received placebo with or without MTX.

  • Received golimumab with or without MTX. Subcutaneous injections were administered every 4 weeks.

  • Patients may appear in more than one column.

  • § Through 12 August 2009.

  • Includes patients with malignancies (excluding nonmelanoma skin cancers, which are not included in the SEER database) during the study.

  • ** The expected number of patients with malignancies is based on the SEER database,13 adjusted for age, gender and race.

  • †† SIR is the observed number of patients with malignancy divided by expected number of patients with malignancy.

  • ‡‡ CI based on an exact method.

  • MTX, methotrexate; SEER, Surveillance, Epidemiology and End Results (database); SIR, standardised incidence ratio.