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Table 2 Reported AEs (all grades) a during treatment with NHS-IL2 in advanced-stage NSCLC patients, deemed treatment related

From: NHS-IL2 combined with radiotherapy: preclinical rationale and phase Ib trial results in metastatic non-small cell lung cancer following first-line chemotherapy

  

0.15 mg/kg (n = 3)

0.30 mg/kg (n = 3)

0.45 mg/kg (n = 7)

Overall (n = 13)

General disorders, n (%)

Anorexia

3 (100.0)

-

2 (28.6)

5 (38.5)

 

Fatigue

3 (100.0)

2 (66.7)

2 (28.6)

7 (53.8)

 

Fever

2 (66.7)

2 (66.7)

-

4 (30.8)

 

Flu-like illness

-

-

3 (42.9)

3 (23.1)

 

Malaise

-

-

2 (28.6)

2 (15.4)

Blood and lymphatic system disorders, n (%)

Lymphopeniab

-

-

1 (14.3)

1 (7.7)

 

Normochromic normocytic anemiab

-

1 (33.3)

-

1 (7.7)

Gastrointestinal symptoms, n (%)

Abdominal pain upper

2 (66.7)

-

-

2 (15.4)

 

Diarrhea

-

1 (33.3)

1 (14.3)

2 (15.4)

 

Eructation

2 (66.7)

-

-

2 (15.4)

 

Nausea

2 (66.7)

-

1 (14.3)

3 (23.1)

 

Stomatitis

1 (33.3)

-

1 (14.3)

2 (15.4)

Respiratory symptoms, n (%)

Dyspnea

1 (33.3)

1 (33.3)

2 (28.6)b

4 (30.8)

 

Productive cough

1 (33.3)

-

1 (14.3)

2 (15.4)

Skin disorders, n (%)

Dry skin

-

2 (66.7)

2 (28.6)

4 (30.8)

 

Pruritus

1 (33.3)

1 (33.3)

1 (14.3)

3 (23.1)

 

Facial/periorbital edemac

-

1 (33.3)

1 (14.3)

2 (15.4)

 

Peripheral edema

-

1 (33.3)

2 (28.6)

3 (23.1)

 

Rash (any)

1 (33.3)

2 (66.7)

3 (42.9)

6 (46.2)

 

  Erythema

1 (33.3)

1 (33.3)

2 (28.6)

4 (30.8)

 

  Rash maculopapular

1 (33.3)

1 (33.3)

1 (14.3)

3 (23.1)

 

  Exfoliative rash

-

1 (33.3)

1 (14.3)

2 (15.4)

Other, n (%)

Atrial fibrillation

-

-

2 (28.6)

2 (15.4)

 

Dry eye

-

1 (33.3)

1 (14.3)

2 (15.4)

 

Hyperthyroidism

-

2 (66.7)

1 (14.3)

3 (23.1)

 

Pericarditis malignantb

-

-

1 (14.3)

1 (7.7)

  1. aAEs were graded according to NCI CTCAE v3.0 and all AEs except where noted were grade 1/2.
  2. bGrade 3-4 AEs occurring in patients during treatment with NHS-IL2; 1 of the 2 patients who reported dyspnea experienced dyspnea grade 4.
  3. cThe facial edema and periorbital edema are in the same patients.
  4. AE, adverse event; NCI-CTCAE, National Cancer Institute Common Terminology Criteria for AEs; NSCLC, non-small cell lung cancer.