Adverse events (AEs) and drug-related AEs
| Huaier (n=686) | Control (n=316) | ||
| AEs | Drug-related AEs | AEs | |
| Overall incidence, n (%) | 175 (25.5) | 160 (23.3) | 72 (22.8) |
| Constitutional symptoms | |||
| Fatigue, n (%) | 2 (<1) | 2 (<1) | 2 (<1) |
| Fever, n (%) | 9 (1.3) | 9 (1.3) | 6 (1.9) |
| Laboratory tests | |||
| *Abnormal liver function†, n (%) | 51 (7.4) | 48 (7.0) | 18 (5.7) |
| Mild leucopenia, n (%) (>3×109/L, but <4×109/L) | 3 (<1) | 3 (<1) | 0 |
| *Abnormal CBC‡, n (%) | 24 (3.5) | 21 (3.1) | 5 (1.6) |
| Respiratory symptoms | |||
| Cough, n (%) | 6 (<1) | 6 (<1) | 0 |
| *Flu-like symptoms, n (%) | 41 (6.0) | 41 (6.0) | 20 (7.0) |
| GI symptoms | |||
| Dyspepsia, n (%) | 3 (<1) | 2 (<1) | 1 (<1) |
| Nausea or emesis, n (%) | 13 (1.9) | 13 (1.9) | 2 (<1) |
| Abdominal pain, n (%) | 5 (<1) | 5 (<1) | 3 (<1) |
| *Diarrhoea, n (%) | 35 (5.0) | 30 (4.4) | 6 (1.9) |
| *Any other complaints§ | 49 (7.1) | 43 (6.3) | 21 (6.6) |
Adverse events, as shown in Medical Dictionary for Regulatory Activities (MedDRA) V.12.0, were classified as being serious or non-serious in accordance with definition adopted by the International Conference on Harmonisation.
*P values were calculated between drug-related AEs in Huaier group and AEs of control group for liver dysfunction, abnormal CBC, flu-like symptoms, diarrhoea and any other complains of 0.4405, 0.1712, 0.8284, 0.0505 and 0.8204, respectively.
†One or more than one of the liver function panel results were abnormal. The liver function panel includes alanine aminotransferase, aspartate aminotransferase, total bilirubin, direct bilirubin, albumin, globulin, serum creatinine, etc.
‡One or more than one of complete blood count (CBC) results were abnormal.
§Record all other complaints during the study, including skin rash, nail disorder, back pain, arthralgia, injury, hypertension, orthostatic hypotension, etc.