Table 4.
Overall treatment-emergent adverse event (TEAE) experience
| (n) | (%) | |
|---|---|---|
| Total population | 800 | (100) |
| Subjects with at least one TEAE | 159 | (19.9) |
| Subjects with ...1 TEAE | 119 | (14.9) |
| ...2 TEAEs | 33 | (4.1) |
| ..3 TEAEs | 7 | (0.9) |
| Nervous system disorders | 52 | (6.5) |
| Dysgeusia | 23 | (2.9) |
| Dizziness | 10 | (1.3) |
| Drowsiness | 6 | (0.8) |
| Somnolence | 5 | (0.6) |
| Headache | 3 | (0.4) |
| Memory impairment | 3 | (0.4) |
| Disturbance in attention | 2 | (0.3) |
| Gastrointestinal disorders | 42 | (5.3) |
| Nausea | 10 | (1.3) |
| Dry mouth | 14 | (1.8) |
| Mouth discomfort | 9 | (1.1) |
| Vomiting | 6 | (0.8) |
| Diarrhea | 2 | (0.3) |
| Oral pain | 1 | (0.1) |
| General disorders and administration site conditions | 23 | (2.9) |
| Feeling abnormal | 9 | (1.1) |
| Fatigue | 8 | (1.0) |
| Application site pain | 6 | (0.8) |
| Psychiatric disorders | 16 | (2.0) |
| Disorientation | 6 | (0.8) |
| Depressed mood | 5 | (0.6) |
| Confusion | 4 | (0.5) |
| Anxiety | 1 | (0.1) |
| Metabolism and nutrition disorders | 56 | (7.0) |
| Increased appetite | 50 | (6.3) |
| Anorexia | 6 | (0.8) |
| Respiratory, thoracic and mediastinal disorders | 17 | (2.1) |
| Pharyngolaryngeal pain | 14 | (1.8) |
| Dyspnoea | 3 | (0.4) |
| Total number of TEAEs | 206 | (100) |
| Metabolism and nutrition disorders | 56 | (27.2) |
| Nervous system disorders | 52 | (25.2) |
| Gastrointestinal disorders | 42 | (20.4) |
| General disorders and administration site conditions | 23 | (11.2) |
| Respiratory, thoracic and mediastinal disorders | 17 | (8.3) |
| Psychiatric disorders | 16 | (7.8) |
| TEAE intensity …mild | 168 | (81.6) |
| …moderate | 34 | (16.5) |
| …severe | 4 | (1.9) |
| TEAE-related treatment discontinuations (pats.) | 32 | (4.0) |
| Discontinuation due to …dysgeusia | 14 | (1.8) |
| …dizziness | 6 | (0.8) |
| …fatigue | 6 | (0.8) |
| …mouth discomfort | 4 | (0.5) |
| …somnolence | 2 | (0.3) |
| Efficacy-related treatment discontinuations (pats.) | 113 | (14.1) |
| Treatment discontinuations for any reasons (pats.) | 145 | (18.1) |