Table 2.
Incidence and severity of adverse events.
| Adverse events | Overall | Severity grade |
||
|---|---|---|---|---|
| Mild | Moderate | Severe | ||
| Non-serious Adverse Events | 67 | 37 | 31 | 0 |
| Serious Adverse Event | 1 | – | – | 1 |
| Fatal Adverse Event | 0 | – | – | |
| Adverse Event leading to discontinuation | 0 | – | – | |
| Reported adverse events | ||||
| IPF & respiratory (16 events) | ||||
| Cough | 6 | 0 | 5 | 1* |
| Shortness of breath | 3 | 0 | 2 | 1* |
| Runny nose, sneezing | 3 | 3 | 0 | 0 |
| Respiratory infection | 1 | 0 | 0 | 1* |
| Low O2 | 1 | 0 | 1 | 0 |
| Other respiratory (e.g. allergies) | 2 | 2 | 0 | 0 |
| General health & well-being (14 events) | ||||
| Feeling generally unwell | 4 | 1 | 2 | 1* |
| Tired/weak | 4 | 1 | 3 | 0 |
| Nonspecific dizziness, light-headedness | 3 | 3 | 0 | 0 |
| Anxiety | 2 | 0 | 2 | 0 |
| Sleeplessness | 1 | 1 | 0 | 0 |
| Skin & bruising (14 events) | ||||
| Skin irritation (steri-strip) | 10 | 9 | 1 | 0 |
| Skin irritation (unrelated to steri-strip) | 2 | 1 | 1 | 0 |
| Bruising (biopsy site) | 1 | 1 | 0 | 0 |
| Bruising (unrelated to study procedure) | 1 | 0 | 1 | 0 |
| Gastrointestinal & appetite (14 events) | ||||
| Nausea | 6 | 3 | 3 | 0 |
| Change in appetite | 2 | 2 | 0 | 0 |
| Constipation | 2 | 1 | 1 | 0 |
| Diarrhea | 2 | 1 | 1 | 0 |
| Indigestion/heartburn | 1 | 1 | 0 | 0 |
| Vomiting | 1 | 0 | 1 | 0 |
| Pain or discomfort (7 events) | ||||
| Headaches | 5 | 2 | 1 | 2 |
| Joint pain or body discomfort | 2 | 2 | 1 | 0 |
| Mouth, eyes (5 events) | ||||
| Dry or watery eyes | 3 | 2 | 1 | 0 |
| Sore/sensitive mouth | 2 | 1 | 2 | 0 |