Table 3 Safety profile summary and most common (frequency ≥ 5%) adverse events (safety analysis set)
Cinepazide maleate (n = 643) | Placebo (n = 648) | Total (n = 1291) | P value for the comparison between groups | |
|---|---|---|---|---|
All adverse events | 527 (82.0) | 545 (84.1) | 1072 (83.0) | 0.30 |
Drug-related adverse events | 61 (9.5) | 79 (12.2) | 140 (10.8) | 0.12 |
Serious adverse events | 62 (9.6) | 74 (11.4) | 136 (10.5) | 0.30 |
Drug-related serious adverse events | 2 (0.3) | 1 (0.2) | 3 (0.2) | 0.99 |
Adverse events leading to discontinuation | 11 (1.7) | 15 (2.3) | 26 (2.0) | 0.44 |
Adverse events leading to death | 10 (1.6) | 13 (2.0) | 23 (1.8) | 0.54 |
Adverse events occurring with a frequency ≥ 5% (total) | 345 (53.7) | 365 (56.3) | 710 (55.0) | 0.33 |
Gastrointestinal diseases | 167 (26.0) | 172 (26.5) | 339 (26.3) | 0.82 |
Constipation | 167 (26.0) | 172 (26.5) | 339 (26.3) | 0.82 |
Infectious diseases | 85 (13.2) | 97 (15.0) | 182 (14.1) | 0.37 |
Upper respiratory tract infection | 29 (4.5) | 42 (6.5) | 71 (5.5) | 0.12 |
Urinary tract infection | 31 (4.8) | 37 (5.7) | 68 (5.3) | 0.47 |
Pulmonary infection | 30 (4.7) | 36 (5.6) | 66 (5.1) | 0.47 |
Metabolic and nutritional diseases | 66 (10.3) | 93(14.4) | 159 (12.3) | 0.025 |
Hypokalemia | 39 (6.1) | 68 (10.5) | 107 (8.3) | 0.004 |
Hypoproteinemia | 35 (5.4) | 40 (6.2) | 75 (5.8) | 0.58 |
Nervous system disorders | 64 (10.0) | 76 (11.7) | 140 (10.8) | 0.31 |
Headache | 40 (6.2) | 46 (7.1) | 86 (6.7) | 0.53 |
Dizziness | 36 (5.6) | 37 (5.7) | 73 (5.7) | 0.93 |
Hepatobiliary diseases | 52 (8.1) | 61 (9.4) | 113 (8.8) | 0.4 |
Liver function abnormalities | 52 (8.1) | 61 (9.4) | 113 (8.8) | 0.4 |
Cardiovascular disorders | 51 (7.9) | 42 (6.5) | 93 (7.2) | 0.31 |
Increased blood pressure | 51 (7.9) | 42 (6.5) | 93 (7.2) | 0.31 |
Psychiatric disorders | 39 (6.1) | 34 (5.3) | 73 (5.7) | 0.52 |
Insomnia | 39 (6.1) | 34 (5.3) | 73 (5.7) | 0.52 |
Respiratory, chest and mediastinal diseases | 29 (4.5) | 37 (5.7) | 66 (5.1) | 0.33 |
Cough | 29 (4.5) | 37 (5.7) | 66 (5.1) | 0.33 |