Table 3. List of adverse events possibly or probably related to the trial.
| Adverse events | Total | LD-SP/SP | LD-SP/PIP | LD-PIP/PIP | LD-PIP/SP | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Number of subjects | Number of subjects | Number of episodes | Mean duration in days (SD) | Number of subjects | Number of episodes | Mean duration in days (SD) | Number of subjects | Number of episodes | Mean duration in days (SD) | Number of subjects | Number of episodes | Mean duration in days (SD) | |
| Fatigue, Malaise | 16 | 4 | 10 | 3.6 (4.5) | 4 | 15 | 2.0 (3.0) | 4 | 10 | 2.9 (1.1) | 4 | 6 | 6.8 (8.1) |
| Headache | 15 | 3 | 12 | 1.0 (1.5) | 4 | 25 | 1.2 (1.2) | 4 | 17 | 1.3 (1.2) | 4 | 21 | 1.6 (1.4)) |
| Fever | 15 | 4 | 9 | 0.4 (0.4) | 4 | 10 | 0.3 (0.4) | 3 | 11 | 0.4 (0.3) | 4 | 13 | 0.7 (0.4) |
| Nausea | 14 | 4 | 12 | 0.6 (0.8) | 4 | 15 | 1.1 (1.6) | 3 | 8 | 1.2 (1.5) | 3 | 10 | 0.7 (1.0) |
| Chills | 14 | 3 | 4 | 1.7 (1.0)) | 3 | 5 | 1.7 (2.0) | 4 | 10 | 1.2 (1.3) | 4 | 6 | 0.9 (1.1) |
| Myalgia | 11 | 3 | 5 | 3.2 (3.3) | 3 | 9 | 2.1 (1.9) | 3 | 5 | 1.2 (1.0) | 2 | 3 | 2.2 (2.6) |
| Abdominal pain | 10 | 2 | 5 | 0.3 (0.2) | 3 | 3 | 0.6 (0.9) | 2 | 8 | 1.1 (1.3) | 3 | 3 | 1.6 (2.4) |
| Pruritis | 6 | 2 | 3 | 0.6 (0.8) | 2 | 2 | 3.3 (0.5) | 1 | 2 | 0.3 (0.4) | 1 | 1 | 3.6 |
| Athralgia | 5 | 1 | 1 | 2.2 | 2 | 4 | 1.5 (1.8) | 0 | - | - | 2 | 2 | 5.1 (3.6) |
| Diarrhoea | 5 | 1 | 1 | 0.8 | 1 | 1 | 0.1 | 2 | 2 | 1.7 (2.1) | 1 | 1 | 4 |
| Diziness | 3 | 1 | 1 | 0.1 | 0 | - | - | 2 | 5 | 0.5 (0.7) | 0 | - | - |
| Reflux | 2 | 0 | - | - | 2 | 2 | 2.9 (1.8) | 0 | - | - | 0 | - | - |
| Pyrosis | 1 | 0 | - | - | 0 | - | - | 0 | - | - | 1 | 1 | 8.6 |
| Aspecific chest pain | 1 | 1 | 2 | 0.0 (0.0) | 0 | - | - | 0 | - | - | 0 | - | - |
| Syncope | 1 | 0 | - | - | 1 | 1 | 0.0 | 0 | - | - | 0 | - | - |
| Mouth ulcera | 1 | 1 | 1 | 10.0 | 0 | - | - | 0 | - | - | 0 | - | - |
| Grade 3 adverse events | |||||||||||||
| Total | 14 | 3 | 4 | 3 | 4 | ||||||||
| Headache | 8 | 0 | - | - | 2 | 2 | 0.3 (0.2) | 2 | 2 | 0.6 (0.1) | 4 | 4 | 1.1 (1.3) |
| Chills | 6 | 1 | 1 | 0.9 | 2 | 2 | 1.7 (2.0) | 2 | 2 | 0.3 (0.3) | 1 | 1 | 2.2 |
| Nausea | 5 | 1 | 1 | 0.1 | 2 | 3 | 0.3 (0.6) | 1 | 1 | 0.7 | 1 | 1 | 0 |
| Fever | 4 | 0 | - | - | 0 | - | - | 2 | 5 | 0.5 (0.4) | 2 | 5 | 0.7 (0.5) |
| Fatigue, malaise | 4 | 0 | - | - | 3 | 4 | 0.8 (0.4) | 1 | 1 | 2 | 0 | - | - |
| Abdominal pain | 1 | 1 | 1 | 0.5 | 0 | - | - | 0 | - | - | 0 | - | - |