TABLE 3.
Adverse events and serious adverse events according to the study group.
| BYF group (n = 276) | Losartan group (n = 278) | Rate ratio (95%CI) | |||
|---|---|---|---|---|---|
| n | Rate per 100 patient-year | n | Rate per 100 patient-year | ||
| Total AE a | 272 | 148.9 | 281 | 161.8 | 0.92 (0.78, 1.09) |
| Hyperkalemia | 164 | 89.8 | 188 | 108.3 | 0.83 (0.67, 1.03) |
| All SAE a , b | 7 | 3.83 | 11 | 6.33 | 0.61 (0.20, 1.71) |
| AE leading to withdrawal | 13 | - | 15 | - | - |
| Neoplasms benign, malignant, and unspecified | 0 | - | 2 | 1.15 | - |
| Hospitalization for endometrial adenocarcinoma | 0 | 1 | |||
| Hospitalization for lung cancer | 0 | 1 | |||
| Cardiac disorders | 1 | 0.55 | 1 | 0.58 | 0.95 (0.01, 74.64) |
| Acute myocardial infarction | 1 | 1 | |||
| Hepatobiliary disorders | 1 | 0.55 | 0 | - | - |
| Hospitalization for liver function disorder | 1 | ||||
| Nervous system disorders | 0 | - | 3 | 1.73 | - |
| Hospitalization for transient ischemic attack | 0 | 1 | |||
| Hospitalization for ischemic stroke | 0 | 1 | |||
| Hospitalization for hemorrhagic stroke | 0 | 1 | |||
| Musculoskeletal and connective tissue disorders | 1 | 0.55 | 0 | - | - |
| Hospitalization for gout | 1 | ||||
| Blood and lymphatic system disorders | 1 | 0.55 | 2 | 1.15 | 0.48 (0.01, 9.13) |
| Hospitalization for decreasing white blood cell counts | 1 | 2 | |||
| Gastrointestinal disorders | 2 | 1.1 | 1 | 0.58 | 1.90 (0.10, 112.2) |
| Hospitalization for peptic ulcer | 1 | 0 | |||
| Hospitalization for erosive gastritis | 1 | 0 | |||
| Death due to gastrointestinal bleeding | 0 | 1 | |||
| Metabolism and nutrition disorders | 0 | - | 1 | 0.58 | - |
| Hospitalization for hyperkalemia | 1 | ||||
| Infections and infestations | 0 | - | 1 | 0.58 | - |
| Hospitalization for pneumonia | |||||
| Other | 1 | 0.55 | 0 | - | - |
| Death due to unknown causes | 1 | 0.55 | 0 | - | - |
a
Adverse events (AEs) and serious AEs (SAEs) were classified according to the Medical Dictionary for Regulatory Activities (MedDRA) central coding dictionary, Chinese version 20.0.
b
A serious adverse event was defined as death, a life-threatening episode, hospitalization, or prolongation of existing hospitalization, a persistent or substantial disability or incapacity, or an event otherwise considered to be an important medical event.
BYF, Bupi Yishen Formula; CI, confidence interval.