Table 2 Adverse events

From: Amivantamab plus lazertinib in osimertinib-relapsed EGFR-mutant advanced non-small cell lung cancer: a phase 1 trial

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

  1. 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.
  2. bEdema includes eyelid edema, face edema, generalized edema, lip edema, edema, edema peripheral, periorbital edema and peripheral swelling.
  3. cFatigue includes asthenia and fatigue.
  4. 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.
  5. eStomatitis includes aphthous ulcer, cheilitis, glossitis, mouth ulceration, mucosal inflammation, pharyngeal inflammation and stomatitis.
  6. fHeadache includes headache and migraine.
  7. gDyspnea includes dypsnea and dyspnea exertional.
  8. hCough includes cough, productive cough and upper airway cough syndrome.
  9. iHemorrhage includes epistaxis, gingival bleeding, hematuria, hemoptysis, hemorrhage, mouth hemorrhage and mucosal hemorrhage.
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