Table 3.
Summary of Adverse Events
| NAVIGATOR41 Phase 3 |
PATHWAY39 Phase 2 |
|||
|---|---|---|---|---|
| Tezepelumab N=528 | Placebo N=531 | Tezepelumaba N=137 | Placebo N=138 |
|
| Patientsb with any AE, n (%) | 407 (77) | 429 (81) | 90 (66) | 91 (66) |
| Patientsb with any serious AE, n (%) | 52 (10) | 73 (14) | 13 (10) | 18 (13) |
| Deaths, n (%) | 0 | 2 (0.4) | 0 | 0 |
| Patientsb with AE leading to discontinuation, n (%) | 11 (2) | 19 (4) | 2 (2) | 1 (1) |
| Patients reporting TEAEs,b n (%) | ||||
| AEs of any grade in ≥5% of patients in either treatment group | ||||
| Asthma | 27 (5) | 59 (11) | 27 (20) | 50 (36) |
| Nasopharyngitis | 113 (21) | 114 (22) | 19 (14) | 16 (12) |
| Upper respiratory tract infection | 59 (11) | 87 (16) | 0 | 0 |
| Headache | 43 (8) | 45 (9) | 11 (8) | 6 (4) |
| Bronchitis | 25 (5) | 33 (6) | 5 (4) | 7 (5) |
Notes: aTezepelumab dose 210 mg SC Q4W; bPatients were counted once for each category regardless of the number of events.
Abbreviations: AE, adverse event; Q4W, every 4 weeks; SC, subcutaneous; TEAEs, treatment-emergent adverse events.