Table 11Patient Disposition

Category or analysis setStudy 301

ravulizumab

N = 125

Study 301

eculizumab

N = 121

Study 302

ravulizumab

N = 97

Study 302

eculizumab

N = 98

Screened, N285208
Randomized, N (%)125 (100.0)121 (100.0)98 (100.0)99 (100.0)
Withdrawal before study treatment, N0011
Received study treatment, N (%)125 (100.0)121 (100.0)97 (99.0)98 (99.0)
Discontinued study, N02 (1.7)1 (1.0)3 (3.0)
Reason for study discontinuation, NNANANANA
  Physician decision0100
  Withdrawal by patient0111
  Lack of efficacy0001
  Pregnancy0001
Full analysis set, N125 (100.0)121 (100.0)97 (99.0)98 (99.0)
PP, N124 (99.2)120 (99.2)93 (94.9)93 (93.9)
Safety, N125 (100.0)121 (100.0)97 (99.0)98 (99.0)

NA = not applicable; PP = per protocol.

Source: Clinical Study Reports for Study 301 and Study 302.1,2

From: Clinical Review

Cover of Ravulizumab (Ultomiris)
Ravulizumab (Ultomiris): CADTH Reimbursement Reviews and Recommendations: Therapeutic area: Paroxysmal nocturnal hemoglobinuria [Internet].
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