Table 4 Adverse events by treatment group, severity and system organ class category.
Placebo (n = 14) | G-PUR 2.0 g (n = 14) | G-PUR 2 * 2.0 g (n = 14) | |
---|---|---|---|
Total | 9 | 7 | 17 |
Severity | |||
Mild | 3 | 2 | 12 |
Moderate | 6 | 5 | 5 |
System organ class | |||
Gastrointestinal disorders | 0 | 1 | 3 |
Infections and infestations | 4 | 1 | 1 |
Nervous system disorder | 5 | 3 | 6 |
Reproductive system and breast disorders | 0 | 0 | 1 |
Respiratory, thoracic and mediastinal disorders | 0 | 1 | 2 |
Skin and subcutaneous tissue disorders | 0 | 1 | 2 |
Vascular disorders | 0 | 0 | 1 |
Fatigue | 0 | 0 | 1 |