Table 2.
Adverse events
| Adverse events (≥10%), n (%) | Osimertinib-relapsed (n = 45) | All-treated (N = 91) | ||
|---|---|---|---|---|
| All-grade | Grade ≥3 | All-grade | Grade ≥3 | |
| Skin and subcutaneous tissue disorders | ||||
| Rasha | 36 (80) | 2 (4) | 81 (89) | 6 (7) |
| Pruritus | 14 (31) | 0 | 31 (34) | 0 |
| Dry skin | 13 (29) | 0 | 16 (18) | 0 |
| Skin fissures | 7 (16) | 0 | 8 (9) | 0 |
| General disorders and administration-site conditions | ||||
| Infusion-related reaction | 35 (78) | 0 | 60 (66) | 1 (1) |
| Edemab | 17 (38) | 0 | 25 (27) | 0 |
| Fatiguec | 12 (27) | 0 | 21 (23) | 1 (1) |
| Pyrexia | 6 (13) | 0 | 12 (13) | 0 |
| Infections and infestations | ||||
| Paronychia | 22 (49) | 2 (4) | 58 (64) | 4 (4) |
| Metabolism and nutrition disorders | ||||
| Hypoalbuminemia | 17 (38) | 1 (2) | 42 (46) | 4 (4) |
| Decreased appetite | 6 (13) | 0 | 19 (21) | 0 |
| Hypocalcemia | 9 (20) | 0 | 14 (15) | 1 (1) |
| Hypomagnesemia | 6 (13) | 0 | 9 (10) | 0 |
| Hyponatremia | 5 (11) | 1 (2) | 8 (9) | 4 (4) |
| Musculoskeletal and connective tissue disorders | ||||
| Musculoskeletal paind | 19 (42) | 1 (2) | 39 (43) | 1 (1) |
| Muscle spasms | 5 (11) | 0 | 8 (9) | 0 |
| Gastrointestinal disorders | ||||
| Stomatitise | 12 (27) | 0 | 34 (37) | 0 |
| Nausea | 20 (44) | 0 | 28 (31) | 1 (1) |
| Constipation | 12 (27) | 0 | 19 (21) | 0 |
| Diarrhea | 10 (22) | 0 | 17 (19) | 1 (1) |
| Dyspepsia | 3 (7) | 0 | 12 (13) | 0 |
| Vomiting | 9 (20) | 0 | 10 (11) | 0 |
| Investigations | ||||
| Increased ALT | 8 (18) | 2 (4) | 29 (32) | 5 (5) |
| Increased AST | 10 (22) | 0 | 26 (29) | 2 (2) |
| Increased blood alkaline phosphatase | 5 (11) | 0 | 6 (7) | 0 |
| Nervous system disorders | ||||
| Paresthesia | 5 (11) | 0 | 23 (25) | 0 |
| Dizziness | 10 (22) | 0 | 19 (21) | 0 |
| Headachef | 9 (20) | 1 (2) | 11 (12) | 1 (1) |
| Respiratory, thoracic and mediastinal disorders | ||||
| Dyspneag | 11 (24) | 3 (7) | 15 (16) | 4 (4) |
| Pulmonary embolism | 4 (9) | 3 (7) | 11 (12) | 3 (3) |
| Coughh | 4 (9) | 0 | 10 (11) | 0 |
| Vascular disorders | ||||
| Hemorrhagei | 6 (13) | 0 | 10 (11) | 0 |
| Hypotension | 5 (11) | 0 | 6 (7) | 0 |
| Blood and lymphatic system disorders | ||||
| Thrombocytopenia | 6 (13) | 0 | 8 (9) | 0 |
| Psychiatric disorders | ||||
| Anxiety | 5 (11) | 0 | 5 (5) | 0 |
aRash includes acne, dermatitis, dermatitis acneiform, eczema, eczema asteatotic, palmar–plantar erythrodysesthesia syndrome, perineal rash, rash, rash erythematous, rash maculo-papular, rash papular, rash vesicular, skin exfoliation and toxic epidermal necrolysis.
bEdema includes eyelid edema, face edema, generalized edema, lip edema, edema, edema peripheral, periorbital edema and peripheral swelling.
cFatigue includes asthenia and fatigue.
dMusculoskeletal pain includes arthralgia, arthritis, back pain, bone pain, musculoskeletal chest pain, musculoskeletal discomfort, musculoskeletal pain, myalgia, neck pain, non-cardiac chest pain, pain in extremity and spinal pain.
eStomatitis includes aphthous ulcer, cheilitis, glossitis, mouth ulceration, mucosal inflammation, pharyngeal inflammation and stomatitis.
fHeadache includes headache and migraine.
gDyspnea includes dypsnea and dyspnea exertional.
hCough includes cough, productive cough and upper airway cough syndrome.
iHemorrhage includes epistaxis, gingival bleeding, hematuria, hemoptysis, hemorrhage, mouth hemorrhage and mucosal hemorrhage.