Incidence of treatment-emergent adverse events occurring in at least 5% of patients in any study group
Event∗ . | No. of patients (%) . | |
---|---|---|
Rivipansel (N = 162) . | Placebo (N = 158) . | |
Blood and lymphatic system disorders | ||
Anemia† | 27 (16.7) | 26 (16.5) |
Sickle cell anemia with crisis‡ | 43 (26.5) | 47 (29.7) |
Gastrointestinal disorders | ||
Abdominal pain | 9 (5.6) | 6 (3.8) |
Constipation | 30 (18.5) | 21 (13.3) |
Nausea | 26 (16.0) | 27 (17.1) |
Vomiting | 17 (10.5) | 16 (10.1) |
General disorders and administration site conditions | ||
Chest pain | 9 (5.6) | 8 (5.1) |
Pyrexia | 29 (17.9) | 33 (20.9) |
Nervous system disorders | ||
Dizziness | 9 (5.6) | 4 (2.5) |
Headache | 19 (11.7) | 30 (19.0) |
Musculoskeletal and connective tissue disorders | ||
Pain in extremity | 9 (5.6) | 8 (5.1) |
Onset during hospitalization | 3 (1.9) | 3 (1.9) |
Onset after hospital discharge | 6 (3.7) | 5 (3.2) |
Respiratory, thoracic, and mediastinal disorders | ||
Acute chest syndrome | 9 (5.6) | 10 (6.3) |
Dyspnea | 10 (6.2) | 3 (1.9) |
Hypoxia | 9 (5.6) | 8 (5.1) |
Skin and subcutaneous tissue disorders | ||
Pruritus | 24 (14.8) | 17 (10.8) |
Rash | 9 (5.6) | 6 (3.8) |
Event∗ . | No. of patients (%) . | |
---|---|---|
Rivipansel (N = 162) . | Placebo (N = 158) . | |
Blood and lymphatic system disorders | ||
Anemia† | 27 (16.7) | 26 (16.5) |
Sickle cell anemia with crisis‡ | 43 (26.5) | 47 (29.7) |
Gastrointestinal disorders | ||
Abdominal pain | 9 (5.6) | 6 (3.8) |
Constipation | 30 (18.5) | 21 (13.3) |
Nausea | 26 (16.0) | 27 (17.1) |
Vomiting | 17 (10.5) | 16 (10.1) |
General disorders and administration site conditions | ||
Chest pain | 9 (5.6) | 8 (5.1) |
Pyrexia | 29 (17.9) | 33 (20.9) |
Nervous system disorders | ||
Dizziness | 9 (5.6) | 4 (2.5) |
Headache | 19 (11.7) | 30 (19.0) |
Musculoskeletal and connective tissue disorders | ||
Pain in extremity | 9 (5.6) | 8 (5.1) |
Onset during hospitalization | 3 (1.9) | 3 (1.9) |
Onset after hospital discharge | 6 (3.7) | 5 (3.2) |
Respiratory, thoracic, and mediastinal disorders | ||
Acute chest syndrome | 9 (5.6) | 10 (6.3) |
Dyspnea | 10 (6.2) | 3 (1.9) |
Hypoxia | 9 (5.6) | 8 (5.1) |
Skin and subcutaneous tissue disorders | ||
Pruritus | 24 (14.8) | 17 (10.8) |
Rash | 9 (5.6) | 6 (3.8) |