Adverse events by system organ class reported in at least 10% of patients in either treatment group
System organ class . | Test, no. (%); n = 60 . | Control, no. (%); n = 61 . | P* . |
|---|---|---|---|
| Any adverse event | 59 (98.3) | 58 (95.1) | .619 |
| Blood and lymphatic-system disorders | 13 (21.7) | 18 (29.5) | .406 |
| Cardiac disorders | 18 (30.0) | 19 (31.1) | ≥ .999 |
| Eye disorders | 6 (10.0) | 3 (4.9) | .323 |
| Gastrointestinal disorders | 36 (60.0) | 38 (62.3) | .853 |
| General disorders and administration site conditions | 30 (50.0) | 29 (47.5) | .856 |
| Hepatobiliary disorders | 17 (28.3) | 22 (36.1) | .438 |
| Immune system disorders | 6 (10.0) | 10 (16.4) | .422 |
| Infections and infestations | 18 (30.0) | 20 (32.8) | .845 |
| Injury and poisoning | 10 (16.7) | 8 (13.1) | .618 |
| Investigations | 22 (35.0) | 25 (41.0) | .585 |
| Metabolism and nutrition disorders | 29 (48.3) | 31 (50.8) | .856 |
| Nervous system disorders | 21 (35.0) | 21 (34.4) | ≥ .999 |
| Psychiatric disorders | 18 (30.0) | 19 (31.1) | ≥ .999 |
| Renal and urinary disorders | 20 (33.3) | 16 (26.2) | .431 |
| Respiratory, thoracic, and mediastinal disorders | 28 (46.7) | 30 (49.2) | .856 |
| Skin and subcutaneous tissue disorders | 8 (13.3) | 8 (13.1) | ≥ .999 |
| Surgical and medical procedures | 25 (41.7) | 35 (57.4) | .103 |
| Vascular disorders | 22 (36.7) | 24 (39.3) | .852 |
System organ class . | Test, no. (%); n = 60 . | Control, no. (%); n = 61 . | P* . |
|---|---|---|---|
| Any adverse event | 59 (98.3) | 58 (95.1) | .619 |
| Blood and lymphatic-system disorders | 13 (21.7) | 18 (29.5) | .406 |
| Cardiac disorders | 18 (30.0) | 19 (31.1) | ≥ .999 |
| Eye disorders | 6 (10.0) | 3 (4.9) | .323 |
| Gastrointestinal disorders | 36 (60.0) | 38 (62.3) | .853 |
| General disorders and administration site conditions | 30 (50.0) | 29 (47.5) | .856 |
| Hepatobiliary disorders | 17 (28.3) | 22 (36.1) | .438 |
| Immune system disorders | 6 (10.0) | 10 (16.4) | .422 |
| Infections and infestations | 18 (30.0) | 20 (32.8) | .845 |
| Injury and poisoning | 10 (16.7) | 8 (13.1) | .618 |
| Investigations | 22 (35.0) | 25 (41.0) | .585 |
| Metabolism and nutrition disorders | 29 (48.3) | 31 (50.8) | .856 |
| Nervous system disorders | 21 (35.0) | 21 (34.4) | ≥ .999 |
| Psychiatric disorders | 18 (30.0) | 19 (31.1) | ≥ .999 |
| Renal and urinary disorders | 20 (33.3) | 16 (26.2) | .431 |
| Respiratory, thoracic, and mediastinal disorders | 28 (46.7) | 30 (49.2) | .856 |
| Skin and subcutaneous tissue disorders | 8 (13.3) | 8 (13.1) | ≥ .999 |
| Surgical and medical procedures | 25 (41.7) | 35 (57.4) | .103 |
| Vascular disorders | 22 (36.7) | 24 (39.3) | .852 |
Based on the Fisher exact test