Table 38Patient Disposition in the Long-Term Extension Study

PLA SCaUST
90 mg SC q.12.w.a90 mg SC q.8.w.aPrior dosage adjustmentb
Randomized patients in clinical response at week 44c
N▬▬▬▬
Treatment discontinuation from week 44 to week 96, n (%)▬▬▬▬
Reasons for discontinuations, n (%)
AEs▬▬▬▬
Lack of efficacy▬▬▬▬
Protocol violation▬▬▬▬
Study termination by sponsor▬▬▬▬
Physician decisiond▬▬▬▬
Lost to follow-upd▬▬▬▬
Withdrawn consentd▬▬▬▬
Death, n (%)▬▬▬▬
Placebo patients who discontinued study treatment due to unblinding (after week 44 analysis completed), n (%)▬▬▬▬
PLA SCe90 mg SC q.12.w.f90 mg SC q.8.w.g-
Non-randomized patients in clinical response at week 44c
N▬▬▬-
Treatment discontinuation from week 44 to week 96, n (%)▬▬▬-
Reasons for discontinuations, n (%)
AEs▬▬▬-
Lack of efficacy▬▬▬-
Protocol violation▬▬▬-
Study termination by sponsor▬▬▬-
Physician decisiond▬▬▬-
Lost to follow-upd▬▬▬-
Withdrawn consentd▬▬▬-
Death, n (%)▬▬▬-
Placebo patients who discontinued study treatment due to unblinding (after week 44 analysis completed), n (%)▬▬▬-

AE = adverse event; PLA = placebo; q.8.w. = every eight weeks; q.12.w. = every 12 weeks; SC = subcutaneous; UST = ustekinumab.

a

▬68

b

▬68

c

▬68

d

▬

e

▬68

f

▬68

g

▬68

Source: Clinical Study Report.68

From: APPENDIX 6, SUMMARY OF THE IM-UNITI EXTENSION STUDY

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