Figure 6:

All adverse events (A) and key safety events (B) during ustekinumab exposure^{†, ‡,§, ¶,††}

†. Number of treatment-emergent adverse events per 100 patient-years of follow-up and 95% confidence interval (rates by each year of follow-up) in the pooled ustekinumab ulcerative colitis safety cohort. Confidence intervals based on an exact method assuming that the observed number of events follows a Poisson distribution.

‡. Infection as assessed by the investigator.

§. Placebo (First Year) includes 1) Patients who were in clinical response to ustekinumab IV induction dosing and were randomized to placebo SC on entry into this maintenance study and were followed after Week 8; and 2) Patients who were in clinical response to placebo IV induction dosing and received placebo SC on entry into this maintenance study. Only includes data from Week 8 onward for patients who were in clinical response to ustekinumab IV induction dosing and were randomized to placebo SC on entry into this maintenance study.

¶. All Ustekinumab (First Year) includes 1) patients who received ustekinumab SC (q8w or q12w) in this maintenance study; and 2) patients who were in clinical response to ustekinumab IV induction dosing and received placebo SC on entry into this maintenance study; 2)data from Week 0 to Week 8 for patients who were in clinical response to ustekinumab IV induction dosing and were randomized to placebo SC on entry into this maintenance study.

††. All Ustekinumab-treated in the LTE (Second Year) includes: 1) Patients who were in clinical response to ustekinumab IV induction dosing and were randomized to receive ustekinumab 90 mg SC q12w or q8w on entry into the maintenance study, with data from Week 44 through Week 96; 2) Patients who were in clinical response to ustekinumab IV induction dosing, randomized to receive placebo SC on entry into the maintenance study, and had a dose adjustment to ustekinumab 90 mg SC q8w, with data from the time of dose adjustment onward; 3) Patients who were not in clinical response to ustekinumab at I-8 but were in clinical response at I-16 after a SC administration of ustekinumab at I-8 and received ustekinumab 90 mg SC q8w on entry into the maintenance study with data from Week 44 through Week 96.

Key: CI, confidence interval; IV, intravenous; NMSC, nonmelanoma skin cancer; q8w, every 8 weeks; 12w, every 12 weeks; SC, subcutaneous