Table 3.
Safety summary
| AE categorya | No. (%) patientsb (N = 28) |
|---|---|
| Any AE | 28 (100.0) |
| Any possibly causally related AEc | 27 (96) |
| Any Grade ≥3 AE | 16 (57) |
| Any Grade ≥3 possibly causally related AEc | 10 (36) |
| Any AE with outcome = death | 0 |
| Any SAE | 4 (14) |
| Any possibly causally related SAEc | 3 (11) |
| Any AE leading to interruption of osimertinib | 9 (32) |
| Any AE leading to reduction of osimertinib | 6 (21) |
| Any AE leading to discontinuation of osimertinib | 5 (18) |
| Any possibly causally related AE leading to discontinuation of osimertinibc | 5 (18) |
| Most common AE (all causality), occurring in ≥15% of patients overall | ||||
|---|---|---|---|---|
| n (%) | Grade 1 | Grade 2 | Grade ≥3 | Total (N = 28) |
| Dry skind | 6 (21) | 7 (25) | 0 | 13 (46) |
| Paronychiad | 9 (32) | 4 (14) | 0 | 13 (46) |
| Diarrhea | 9 (32) | 1 (4) | 0 | 10 (36) |
| Rashd | 7 (25) | 2 (7) | 1 (4) | 10 (36) |
| Stomatitis | 7 (25) | 3 (11) | 0 | 10 (36) |
| Anemia | 2 (7) | 3 (11) | 1 (4) | 6 (21) |
| Neutrophil count decreased | 0 | 3 (11) | 3 (11) | 6 (21) |
| White blood cell count decreased | 0 | 4 (14) | 2 (7) | 6 (21) |
| Decreased appetite | 2 (7) | 3 (11) | 0 | 5 (18) |
| Electrocardiogram QT prolongation | 4 (14) | 1 (4) | 0 | 5 (18) |
| ILD‐like AEd | 1 (4) | 1 (4) | 3 (11) | 5 (18) |
| Nausea | 0 | 4 (14) | 1 (4) | 5 (18) |
| Neutropenia | 0 | 3 (11) | 2 (7) | 5 (18) |
| Upper respiratory tract infection | 2 (7) | 3 (11) | 0 | 5 (18) |
AE, adverse event; ILD, interstitial lung disease; SAE, serious adverse event.
a
Includes AE with an onset date on or after the date of first dose and up to and including 28 days following the date of the last dose of study medication.
b
Patients with multiple events in the same category are counted only once in that category. Patients with events in more than 1 category are counted once in each of those categories.
c
As assessed by the investigator.
d
This category represents a grouped term for the event.