Table 5.
Subjects with treatment-emergent adverse events or severe nasal symptoms
| System organ class preferred term | IV | IN powder | IN solution | PBO | Overall | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| 4 mg | 10 mg | 20 mg | 40 mg | 10 mg | 20 mg | 40 mg | Solution | Powder | ||
| (N = 12) | (N = 11) | (N = 11) | (N = 10) | (N = 11) | (N = 11) | (N = 10) | (N = 11) | (N = 11) | (N = 12) | |
| n (%) | ||||||||||
| Total subjects with at least 1 TEAE | 7 (58.3) | 7 (63.6) | 9 (81.8) | 10 (100) | 9 (81.8) | 8 (72.7) | 10 (100) | 3 (27.3) | 3 (27.3) | 12 (100) |
| Ear and labyrinth disorders | 1 (8.3) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (8.3) |
| Hyperacusis | 1 (8.3) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (8.3) |
| Eye disorders | 0 | 0 | 0 | 1 (10.0) | 0 | 1 (9.1) | 1 (10.0) | 0 | 0 | 2 (16.7) |
| Eye irritation | 0 | 0 | 0 | 0 | 0 | 1 (9.1) | 0 | 0 | 0 | 1 (8.3) |
| Diplopia | 0 | 0 | 0 | 1 (10.0) | 0 | 0 | 1 (10.0) | 0 | 0 | 1 (8.3) |
| Gastrointestinal disorders | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (9.1) | 1 (9.1) | 1 (8.3) |
| Toothache | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (9.1) | 0 | 1 (8.3) |
| Paraesthesia oral | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (9.1) | 1 (8.3) |
| General disorders and administration site conditions | 2 (16.7) | 0 | 0 | 1 (10.0) | 1 (9.1) | 0 | 3 (30.0) | 1 (9.1) | 0 | 4 (33.3) |
| Feeling abnormal | 2 (16.7) | 0 | 0 | 0 | 1 (9.1) | 0 | 2 (20.0) | 1 (9.1) | 0 | 3 (25.0) |
| Feeling of relaxation | 0 | 0 | 0 | 1 (10.0) | 0 | 0 | 1 (10.0) | 0 | 0 | 1 (8.3) |
| Infections and infestations | 0 | 0 | 1 (9.1) | 0 | 0 | 0 | 0 | 0 | 1 (8.3) | |
| Folliculitis | 0 | 0 | 1 (9.1) | 0 | 0 | 0 | 0 | 0 | 0 | 1 (8.3) |
| Injury, poisoning and procedural complications | 0 | 0 | 0 | 0 | 0 | 0 | 1 (10.0) | 0 | 0 | 1 (8.3) |
| Limb injury | 0 | 0 | 0 | 0 | 0 | 0 | 1 (10.0) | 0 | 0 | 1 (8.3) |
| Investigations | 1 (8.3) | 2 (18.2) | 1 (9.1) | 2 (20.0) | 4 (36.4) | 5 (45.5) | 2 (20.0) | 1 (9.1) | 0 | 12 (100) |
| Blood pressure diastolic increased | 1 (8.3) | 1 (9.1) | 1 (9.1) | 0 | 1 (9.1) | 3 (27.3) | 1 (10.0) | 0 | 0 | 8 (66.7) |
| Blood pressure diastolic decreased | 0 | 1 (9.1) | 0 | 1 (10.0) | 3 (27.3) | 2 (18.2) | 0 | 1 (9.1) | 0 | 8 (66.7) |
| Blood pressure systolic increased | 0 | 0 | 0 | 0 | 1 (9.1) | 0 | 2 (20.0) | 0 | 0 | 3 (25.0) |
| Blood pressure systolic decreased | 0 | 0 | 0 | 1 (10.0) | 0 | 0 | 0 | 0 | 0 | 1 (8.3) |
| Nervous system disorders | 2 (16.7) | 0 | 1 (9.1) | 6 (60.0) | 1 (9.1) | 2 (18.2) | 2 (20.0) | 1 (9.1) | 2 (18.2) | 11 (91.7) |
| Somnolence | 0 | 0 | 0 | 5 (50.0) | 0 | 1 (9.1) | 2 (20.0) | 0 | 0 | 8 (66.7) |
| Headache | 0 | 0 | 0 | 0 | 0 | 0 | 1 (10.0) | 1 (9.1) | 2 (18.2) | 3 (25.0) |
| Sedation | 0 | 0 | 0 | 1 (10.0) | 0 | 0 | 0 | 0 | 0 | 1 (8.3) |
| Dysgeusia | 0 | 0 | 0 | 0 | 0 | 1 (9.1) | 0 | 0 | 0 | 1 (8.3) |
| Dizziness | 1 (8.3) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (8.3) |
| Disturbance in attention | 1 (8.3) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (8.3) |
| Cognitive disorder | 0 | 0 | 1 (9.1) | 0 | 1 (9.1) | 0 | 0 | 0 | 0 | 1 (8.3) |
| Psychiatric disorders | 4 (33.3) | 5 (45.5) | 6 (54.5) | 3 (30.0) | 1 (9.1) | 4 (36.4) | 5 (50.0) | 0 | 1 (9.1) | 9 (75.0) |
| Euphoric mood | 2 (16.7) | 3 (27.3) | 4 (36.4) | 2 (20.0) | 1 (9.1) | 2 (18.2) | 4 (40.0) | 0 | 1 (9.1) | 7 (58.3) |
| Illusion | 2 (16.7) | 1 (9.1) | 1 (9.1) | 1 (10.0) | 0 | 1 (9.1) | 0 | 0 | 0 | 3 (25.0) |
| Thinking abnormal | 0 | 0 | 0 | 0 | 0 | 1 (9.1) | 0 | 0 | 0 | 1 (8.3) |
| Hypervigilance | 0 | 0 | 0 | 0 | 0 | 0 | 1 (10.0) | 0 | 0 | 1 (8.3) |
| Disorientation | 0 | 1 (9.1) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (8.3) |
| Communication disorder | 0 | 0 | 1 (9.1) | 0 | 0 | 0 | 0 | 0 | 0 | 1 (8.3) |
| Respiratory, thoracic and mediastinal disorders | 1 (9.1) | 2 (18.2) | 2 (20.0) | 5 (45.5) | 2 (18.2) | 5 (50.0) | 0 | 0 | 7 (58.3) | |
| Nasal discomfort | 0 | 1 (9.1) | 1 (9.1) | 1 (10.0) | 5 (45.5) | 2 (18.2) | 4 (40.0) | 0 | 0 | 7 (58.3) |
| Throat irritation | 0 | 0 | 0 | 1 (10.0) | 2 (18.2) | 1 (9.1) | 3 (30.0) | 0 | 0 | 6 (50.0) |
| Sneezing | 0 | 0 | 0 | 1 (10.0) | 0 | 0 | 1 (10.0) | 0 | 0 | 1 (8.3) |
| Paranasal sinus discomfort | 0 | 0 | 1 (9.1) | 0 | 0 | 0 | 0 | 0 | 0 | 1 (8.3) |
| Nasal congestion | 0 | 0 | 1 (9.1) | 0 | 0 | 0 | 0 | 0 | 0 | 1 (8.3) |
| Number of subjects by symptom with severe grading on Nasal Effects Questionnaire at 5 min post-dose | ||||||||||
| Blow | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Burning | 0 | 1 | 2 | 0 | 2 | 1 | 0 | 0 | 0 | 0 |
| Congestion | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Irritation | 0 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 |
| Pain | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Runny | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Throat | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |