Table 12Major Protocol Deviations

Protocol deviationStudy 301

ravulizumab

N = 125

Study 301

eculizumab

N = 121

Study 302

ravulizumab

N = 97

Study 302

eculizumab

N = 98

Patients with ≥ 1 major protocol deviation, n (%)13 (10.4)20 (16.5)16 (16.5)14 (14.3)
  Failure to follow transfusion guidelines4 (3.2)8 (6.6)3 (3.1)5 (5.1)
  Other study procedures/tests0 (0.0)0 (0.0)5 (5.2)1 (1.0)
  Informed consent4 (3.2)3 (2.5)2 (2.1)0 (0.0)
  Delayed safety reporting3 (2.4)3 (2.5)0 (0.0)2 (2.0)
  Assigned to incorrect stratification group1 (0.8)4 (3.3)1 (1.0)2 (2.0)
  Single dose missed or single dose was less than planned dose1 (0.8)2 (1.7)0 (0.0)0 (0.0)
  Did not meet eligibility criteriaa0 (0.0)2 (1.7)5 (5.2)2 (2.0)
  Laboratory assessment criteria (test not performed or sample cancelled)0 (0.0)0 (0.0)2 (2.1)2 (2.0)

LDH = lactate dehydrogenase.

Note: Results are presented for the full analysis set.

a

Reasons: untreated basal cell carcinoma, randomization before documentation of HIV results, prior doses of eculizumab administered outside ± 2-day window, no vaccination for meningococcal infection within 3 years, randomization without screening LDH value, and prior LDH value greater than 2 × ULN in patients who had been receiving eculizumab.

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

From: Clinical Review

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