Number of patients with AEs in any category on treatment and most common AEs by preferred term (safety analysis set)
| AE category* . | Ticagrelor group (n = 100) . | Placebo group (n = 92) . |
|---|---|---|
| Any AE | 95 (95) | 84 (91) |
| AE with maximum intensity* | ||
| Mild | 21 (21) | 16 (17) |
| Moderate | 32 (32) | 39 (42) |
| Severe | 42 (42) | 29 (32) |
| Patients with bleeding events | 9 (9) | 8 (9) |
| Major† | 1 (1) | 0 |
| Clinically relevant nonmajor‡ | 0 | 0 |
| Minor§ | 8 (8) | 8 (9) |
| Any AE with outcome death | 3 (3) | 1 (1) |
| Any serious AE | 44 (44) | 29 (32) |
| Any AE leading to study drug discontinuation | 4 (4) | 4 (4) |
| AEs with ≥10% frequency | ||
| Sickle cell anemia with crisis | 71 (71) | 57 (62) |
| Pain in extremity | 28 (28) | 23 (25) |
| Headache | 24 (24) | 18 (20) |
| Back pain | 21 (21) | 12 (13) |
| Upper respiratory tract infection | 20 (20) | 24 (26) |
| Cough | 17 (17) | 7 (8) |
| Arthralgia | 14 (14) | 14 (15) |
| Abdominal pain | 15 (15) | 10 (11) |
| Malaria | 15 (15) | 8 (9) |
| Pyrexia | 13 (13) | 13 (14) |
| Anemia | 10 (10) | 11 (12) |
| AE category* . | Ticagrelor group (n = 100) . | Placebo group (n = 92) . |
|---|---|---|
| Any AE | 95 (95) | 84 (91) |
| AE with maximum intensity* | ||
| Mild | 21 (21) | 16 (17) |
| Moderate | 32 (32) | 39 (42) |
| Severe | 42 (42) | 29 (32) |
| Patients with bleeding events | 9 (9) | 8 (9) |
| Major† | 1 (1) | 0 |
| Clinically relevant nonmajor‡ | 0 | 0 |
| Minor§ | 8 (8) | 8 (9) |
| Any AE with outcome death | 3 (3) | 1 (1) |
| Any serious AE | 44 (44) | 29 (32) |
| Any AE leading to study drug discontinuation | 4 (4) | 4 (4) |
| AEs with ≥10% frequency | ||
| Sickle cell anemia with crisis | 71 (71) | 57 (62) |
| Pain in extremity | 28 (28) | 23 (25) |
| Headache | 24 (24) | 18 (20) |
| Back pain | 21 (21) | 12 (13) |
| Upper respiratory tract infection | 20 (20) | 24 (26) |
| Cough | 17 (17) | 7 (8) |
| Arthralgia | 14 (14) | 14 (15) |
| Abdominal pain | 15 (15) | 10 (11) |
| Malaria | 15 (15) | 8 (9) |
| Pyrexia | 13 (13) | 13 (14) |
| Anemia | 10 (10) | 11 (12) |
Data are expressed as n (%). AEs on treatment: AEs with onset date on or after the date of first dose of study treatment and on or before the date of last dose of study treatment plus 7 days. AEs were recorded by using the Medical Dictionary for Regulatory Activities version 23.0.
Patients with multiple events in the same category are counted only once in the maximum intensity category. Patients with events in >1 category are counted once in each of those categories.
Major bleeding was defined as any fatal bleeding; clinically overt bleeding associated with a decrease in hemoglobin levels of at least 20 g/L (2 g/dL); bleeding that is retroperitoneal, pulmonary, intracranial, or otherwise involves the central nervous system; or bleeding that requires surgical intervention in an operating suite.
Clinically relevant nonmajor bleeding was defined as overt bleeding for which a blood product is administered and which is not directly attributable to the patient’s underlying medical condition, and bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating room.
Minor bleeding was defined as any overt or macroscopic evidence of bleeding that does not fulfill the criteria for either major bleeding or clinically relevant, nonmajor bleeding.