Table 29Summary of Harms in the Extension Period

Adverse eventsStudy 301Study 302
RAV–RAV

Period 2

N = 125

ECU–RAV

Period 2

N = 121

RAV–RAV

Period 2

N = 96

ECU–RAV

Period 2

N = 95

Patients with ≥ 1 AE
n (%)79 (63.7)89 (74.8)76 (79.2)71 (74.7)
Most common eventsa
    Anemia0 (0.0)6 (5.0)1 (1.0)5 (5.3)
    Nausea2 (1.6)6 (5.0)3 (3.1)3 (3.2)
    Diarrhea2 (1.6)4 (3.4)6 (6.3)5 (5.3)
    Abdominal pain3 (2.4)6 (5.0)4 (4.2)4 (4.2)
    Constipation0 (0.0)0 (0.0)0 (0.0)1 (1.1)
    Dyspepsia0 (0.0)0 (0.0)0 (0.0)0 (0.0)
    Vomiting0 (0.0)0 (0.0)3 (3.1)0 (0.0)
    Influenza-like illness0 (0.0)0 (0.0)1 (1.0)4 (4.2)
    Pyrexia7 (5.6)0 (0.0)6 (6.3)6 (6.3)
    Fatigue0 (0.0)0 (0.0)13 (13.5)13 (13.7)
    Chest pain0 (0.0)0 (0.0)0 (0.0)1 (1.1)
    Nasopharyngitis8 (5.6)15 (12.6)6 (6.3)7 (7.4)
    Upper respiratory tract infection10 (8.1)5 (4.2)9 (9.4)8 (8.4)
    Viral upper respiratory tract infection3 (2.4)2 (1.7)0 (0.0)0 (0.0)
    Rhinitis0 (0.0)0 (0.0)4 (4.2)0 (0.0)
    Arthralgia3 (2.4)5 (4.2)0 (0.0)0 (0.0)
    Myalgia1 (0.8)3 (2.5)0 (0.0)0 (0.0)
    Pain in extremity0 (0.0)3 (2.5)4 (4.2)5 (5.3)
    Back pain1 (0.8)0 (0.0)0 (0.0)6 (6.3)
    Musculoskeletal pain0 (0.0)0 (0.0)0 (0.0)1 (1.1)
  Nervous system disorders
    Headache6 (4.8)10 (8.4)6 (6.3)10 (10.5)
    Dizziness0 (0.0)0 (0.0)0 (0.0)6 (6.3)
    Oropharyngeal pain0 (0.0)0 (0.0)0 (0.0)2 (2.1)
    Cough0 (0.0)4 (3.4)3 (3.1)4 (4.2)
    Dyspnea0 (0.0)1 (0.8)0 (0.0)3 (3.2)
Patients with ≥ 1 SAE
n (%)9 (7.3)7 (5.9)8 (8.3)5 (5.3)
Patients who discontinued study drug due to AE
n (%)0 (0.0)2 (1.7)b0 (0.0)0 (0.0)
Deaths
n (%)0 (0.0)0 (0.0)c0 (0.0)0 (0.0)
Notable harms, n (%)
Serious infections (other than meningococcal and aspergillus)2 (1.6)4 (3.4)3 (3.1)2 (2.1)
Infusion reactions5 (4.0)7 (5.9)2 (2.1)1 (1.1)

AE = adverse event; ECU = eculizumab; RAV = ravulizumab; SAE = serious adverse event.

Note: Period 2 refers to the extension period of 26 weeks or greater to 52 weeks.

a

Frequency is reported if 5% or greater in any treatment group or presented as part of the primary evaluation period in an earlier section of this review.

b

One patient developed a lung adenocarcinoma and discontinued the study drug, this patient later died and is discussed in footnote C. A second patient developed myelodysplastic syndrome and discontinued study drug.

c

One death that occurred during the extension period was reported in Period 1 because onset of the lung adenocarcinoma occurred during Period 1. A second death due to pulmonary sepsis occurred during Period 3, beyond the 52-week data cut-off.

Source: Clinical Study Reports for Study 301 and Study 302 (52-week data update).22,23

From: Clinical Review

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