Table 4.
Incidence rates of TEAEs occurring in ≥ 10% of patients and other TEAEs of interest
| TEAE by preferred term | Patients with ≥ 1 event, n (%) (N = 83) |
Events, n | Adjusted incidence per 100 PEYa |
|---|---|---|---|
| TEAEs occurring in ≥ 10% of patients | 82 (98.8) | 1288 | 460.5 |
| Nausea | 40 (48.2) | 66 | 23.6 |
| IPF | 29 (34.9) | 45 | 16.1 |
| Fatigue | 27 (32.5) | 33 | 11.8 |
| Dyspnea | 25 (30.1) | 32 | 11.4 |
| Upper respiratory tract infection | 21 (25.3) | 32 | 11.4 |
| Cough | 21 (25.3) | 30 | 10.7 |
| Rash | 16 (19.3) | 22 | 7.9 |
| Weight decreased | 18 (21.7) | 20 | 7.2 |
| Vomiting | 13 (15.7) | 20 | 7.2 |
| Bronchitis | 12 (14.5) | 19 | 6.8 |
| Urinary tract infection | 11 (13.3) | 19 | 6.8 |
| Insomnia | 15 (18.1) | 18 | 6.4 |
| Headache | 14 (16.9) | 17 | 6.1 |
| Appetite decreased | 14 (16.9) | 16 | 5.7 |
| Sinusitis | 11 (13.3) | 15 | 5.4 |
| Depression | 12 (14.5) | 14 | 5.0 |
| Anorexia | 11 (13.3) | 14 | 5.0 |
| Dizziness | 12 (14.5) | 13 | 4.6 |
| Pneumonia | 10 (12.0) | 13 | 4.6 |
| Diarrhea | 10 (12.0) | 13 | 4.6 |
| Back pain | 10 (12.0) | 13 | 4.6 |
| Anxiety | 10 (12.0) | 13 | 4.6 |
| Constipation | 10 (12.0) | 12 | 4.3 |
| Gastroesophageal reflux disease | 10 (12.0) | 12 | 4.3 |
| Pulmonary hypertension | 10 (12.0) | 10 | 3.6 |
| Peripheral edema | 9 (10.8) | 9 | 3.2 |
| Other TEAEs of interest | |||
| Respiratory tract infection | 6 (7.2) | 11 | 3.9 |
| Photosensitivity reaction | 6 (7.2) | 10 | 3.6 |
| Abdominal discomfort | 7 (8.4) | 9 | 3.2 |
| Respiratory failure | 6 (7.2) | 8 | 2.9 |
| Dyspepsia | 7 (8.4) | 7 | 2.5 |
| Stomach discomfort | 5 (6.0) | 6 | 2.1 |
IPF idiopathic pulmonary fibrosis, PEY patient exposure years, TEAE treatment-emergent adverse event
aAdjusted incidence = number of events/total exposure in PEY × 100. The total exposure was 279.7 PEY