Number and percentage of subjects with treatment-emergent SAEs
| System organ class preferred term* . | Sildenafil (n = 37), n % . | Placebo (n = 37), n % . | P† . |
|---|---|---|---|
| Any treatment-emergent SAE | 17 (46) | 8 (22) | .02 |
| Congenital, familial, and genetic disorder sickle cell anemia with crisis | 13 (35) | 5 (14) | .03 |
| Blood and lymphatic system disorders | 3 (8) | 4 (11) | .69 |
| Acute chest syndrome | 1 (3) | 3 (8) | .28 |
| Anemia | 2 (5) | 1 (3) | .56 |
| Infections and infestations | 2 (5) | 0 (0) | .16 |
| Bronchitis | 1 (3) | 0 (0) | .32 |
| Lower respiratory tract infection | 1 (3) | 0 (0) | .32 |
| Metabolism and nutrition disorders | |||
| Hyperkalemia | 0 (0) | 2 (5) | .16 |
| Vascular disorders | 1 (3) | 1 (3) | > .999 |
| Hypertension | 0 (0) | 1 (3) | .32 |
| Hypotension | 1 (3) | 0 (0) | .32 |
| Cardiac disorders | 1 (3) | 0 (0) | .32 |
| Atrial fibrillation | 1 (3) | 0 (0) | .32 |
| Cardiac failure congestive | 1 (3) | 0 (0) | .32 |
| Eye disorders | |||
| Vitreous hemorrhage | 1 (3) | 0 (0) | .32 |
| General disorders and administration site conditions | |||
| Pyrexia | 1 (3) | 0 (0) | .32 |
| Injury, poisoning, and procedural complications | |||
| Traumatic brain injury | 1 (3) | 0 (0) | .32 |
| Psychiatric disorders | |||
| Suicide attempt | 1 (3) | 0 (0) | .32 |
| Respiratory, thoracic, and mediastinal disorders | |||
| Acute pulmonary edema | 1 (3) | 0 (0) | .32 |
| System organ class preferred term* . | Sildenafil (n = 37), n % . | Placebo (n = 37), n % . | P† . |
|---|---|---|---|
| Any treatment-emergent SAE | 17 (46) | 8 (22) | .02 |
| Congenital, familial, and genetic disorder sickle cell anemia with crisis | 13 (35) | 5 (14) | .03 |
| Blood and lymphatic system disorders | 3 (8) | 4 (11) | .69 |
| Acute chest syndrome | 1 (3) | 3 (8) | .28 |
| Anemia | 2 (5) | 1 (3) | .56 |
| Infections and infestations | 2 (5) | 0 (0) | .16 |
| Bronchitis | 1 (3) | 0 (0) | .32 |
| Lower respiratory tract infection | 1 (3) | 0 (0) | .32 |
| Metabolism and nutrition disorders | |||
| Hyperkalemia | 0 (0) | 2 (5) | .16 |
| Vascular disorders | 1 (3) | 1 (3) | > .999 |
| Hypertension | 0 (0) | 1 (3) | .32 |
| Hypotension | 1 (3) | 0 (0) | .32 |
| Cardiac disorders | 1 (3) | 0 (0) | .32 |
| Atrial fibrillation | 1 (3) | 0 (0) | .32 |
| Cardiac failure congestive | 1 (3) | 0 (0) | .32 |
| Eye disorders | |||
| Vitreous hemorrhage | 1 (3) | 0 (0) | .32 |
| General disorders and administration site conditions | |||
| Pyrexia | 1 (3) | 0 (0) | .32 |
| Injury, poisoning, and procedural complications | |||
| Traumatic brain injury | 1 (3) | 0 (0) | .32 |
| Psychiatric disorders | |||
| Suicide attempt | 1 (3) | 0 (0) | .32 |
| Respiratory, thoracic, and mediastinal disorders | |||
| Acute pulmonary edema | 1 (3) | 0 (0) | .32 |
System organ class and preferred term were based on MedDRA Version 10.1. If a subject experienced more than one episode of an adverse event, the subject was counted once for that preferred term. If a subject had more than one adverse event in a system organ class, the subject was counted once for that system organ class.
P value corresponds to a Cochran-Mantel-Haenszel χ2 test of no difference between treatments while controlling for strata.