TABLE 4.
TEAEs in Phase 3 Studies for Levodopa Inhalation Powder
| SPAN-PD CVT-301-00439 | CVT-301-004E40 | CVT-301-00541 | |||
|---|---|---|---|---|---|
| Levodopa Inhalation Powder 60 mg (n = 113) | Levodopa Inhalation Powder 84 mg (n = 114) | Levodopa Inhalation Powder 60 mg (n = 153) | Levodopa Inhalation Powder 84 mg (n = 159) | Levodopa Inhalation Powder 84 mg (n = 271)* | |
| Adverse event, n (%)* | |||||
| Any TEAE | 64 (56.6) | 66 (57.9) | 103 (67.3) | 115 (72.3) | 192 (70.8) |
| Serious TEAE | 6 (5.3) | 2 (1.8) | 22 (14.4) | 13 (8.2) | 42 (15.5) |
| TEAE leading to withdrawal | 3 (2.7) | 6 (5.3) | 12 (7.8) | 14 (8.8) | 24 (8.9) |
| Drug-related TEAEs† | 41 (36.3) | 40 (35.1) | 45 (29.4) | 51 (32.1) | 102 (37.6) |
| Severe TEAEs | 7 (6.2) | 5 (4.4) | 19 (12.4) | 12 (7.5) | 36 (13.3) |
| TEAEs in ≥4% of patients, n (%) | |||||
| Cough | 17 (15.0) | 17 (14.9) | 25 (16.3) | 23 (14.5) | 36 (13.3) |
| Upper respiratory tract infection | 2 (1.8) | 7 (6.1) | 10 (6.5) | 12 (7.5) | 13 (4.8) |
| Nausea | 0 | 6 (5.3) | 2 (1.3) | 0 | 10 (3.7) |
| Sputum discolored | 0 | 6 (5.3) | 1 (0.7) | 2 (1.3) | 9 (3.3) |
| Dyskinesia | 5 (4.4) | 4 (3.5) | 6 (3.9) | 10 (6.3) | 17 (6.3) |
| Fall | 5 (4.4) | 3 (2.6) | 24 (15.7) | 17 (10.7) | 22 (8.1) |
| Nasopharyngitis | 2 (1.8) | 3 (2.6) | 8 (5.2) | 4 (2.5) | 18 (6.6) |
| Back pain | 4 (3.5) | 1 (0.9) | 8 (5.2) | 3 (1.9) | 12 (4.4) |
| Throat irritation | 8 (7.1) | 1 (0.9) | 7 (4.6) | 5 (3.1) | 9 (3.3) |
| Dizziness | 2 (1.8) | 1 (0.9) | 5 (3.3) | 4 (2.5) | 6 (2.2) |
| Constipation | 1 (0.9) | 0 | 5 (3.3) | 7 (4.4) | 2 (0.7) |
*Levodopa inhalation powder safety population
†Adverse events were considered drug related if the event was classified as possibly, probably, or definitely related to study drug by investigators.
TEAEs, treatment-emergent adverse events.