Table 3 Drug related adverse events in the safety population (n = 31), including any AE experienced by ≥5% of the cohort and all grade 3 AEs. Note that there were no grade 4 or 5 drug related AEs

Blood and lymphatic system disorders

Anemia

5

16.1%

-

-

Cardiac disorders

Atrial fibrillation

-

-

1

3.2%

Endocrine disorders

Hypophysitis

1

3.2%

1

3.2%

Hypothyroidism

2

6.5%

1

3.2%

Eye disorders

Dry Eye

3

9.7%

-

-

Gastrointestinal disorders

Abdominal Pain

2

6.5%

-

-

Colitis

2

6.5%

2

6.5%

Constipation

4

12.9%

-

-

Diarrhea

17

54.8%

-

-

Dry Mouth

5

16.1%

-

-

Flatulence

2

6.5%

-

-

Nausea

16

51.6%

2

6.5%

Vomiting

8

25.8%

1

3.2%

General disorders and administration site conditions

Chills

19

61.3%

-

-

Fatigue

28

90.3%

1

3.2%

Fever

15

48.4%

-

-

Flu like symptoms

7

22.6%

-

-

Injection site reaction

7

22.6%

-

-

Infusion reaction

3

9.7%

-

-

Malaise

3

9.7%

-

-

Night Sweats

4

12.9%

-

-

Investigations

Alanine aminotransferase increased

8

25.8%

-

-

Alkaline phosphatase increased

2

6.5%

-

-

Aspartate aminotransferase increased

8

25.8%

-

-

Lymphocyte count decreased

4

12.9%

1

3.2%

Neutrophil count decreased

3

9.7%

3

9.7%

Platelet count decreased

6

19.4%

-

-

Weight loss

5

16.1%

-

-

White blood cell decreased

8

25.8%

2

6.5%

Metabolism and nutrition disorders

Anorexia

16

51.6%

-

-

Dehydration

1

3.2%

2

6.5%

Hyponatremia

-

-

2

6.5%

Muskuloskeletal and connective tissue disorders

Arthralgia

15

48.4%

1

3.2%

Myalgia

2

6.5%

-

-

Nervous system disorders

Dizziness

5

16.1%

-

-

Dysgeusia

8

25.8%

-

-

Headache

17

54.8%

-

-

Syncope

-

-

1

3.2%

Psychiatric disorders

Anxiety

3

9.7%

-

-

Depression

5

16.1%

-

-

Respiratory, thoracic and mediastinal disorders

Cough

7

22.6%

-

-

Dyspnea

8

25.8%

-

-

Productive Cough

2

6.5%

-

-

Skin and subcutaneous tissue disorders

Alopecia

6

19.4%

-

-

Dry Skin

4

12.9%

-

-

Pruritus

18

58.1%

2

6.5%

Rash

22

71.0%

4

12.9%

Skin hypopigmentation

7

22.6%

-

-

Any

31

100%

15

48.4%