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Table 3 Adverse events related to the canfosfamide and pegylated liposomal doxorubicin combination (NCI-CTC v2.0) (N = 39)

From: Phase 2 study of canfosfamide in combination with pegylated liposomal doxorubicin in platinum and paclitaxel refractory or resistant epithelial ovarian cancer

 

Grade 1

n (%)

Grade 2

n (%)

Grade 3

n (%)

Grade 4

n (%)

Hematologic (All Patients)

    

   Anemia

9 (23.1)

21 (53.8)

5 (12.8)

1 (2.6)

   Leucopenia

3 (7.7)

13 (33.3)

15 (38.5)

2 (5.1)

   Neutropenia

0 (0.0)

8 (20.5)

12 (30.8)

11 (28.2)

   Thrombocytopenia

10 (25.6)

5 (12.8)

10 (25.6)

0 (0.0)

   Leukocytosis

8 (20.5)

0 (0.0)

0 (0.0)

0 (0.0)

   Febrile Neutropenia

0 (0.0)

0 (0.0)

2 (5.1)

0 (0.0)

Non-hematologic (≥ 5% of patients)

    

   Nausea

9 (23.1)

20 (51.3)

6 (15.4)

0 (0.0)

   Fatigue

1 (2.6)

11 (28.2)

20 (51.3)

1 (2.6)

   Vomiting

10 (25.6)

8 (20.5)

4 (10.3)

0 (0.0)

   Rash

8 (20.5)

12 (30.8)

3 (7.7)

0 (0.0)

   Diarrhea

1 (2.6)

6 (15.4)

3 (7.7)

0 (0.0)

   Drug Hypersensitivity

1 (2.6)

1 (2.6)

1 (2.6)

0 (0.0)

   Infusion Site Pain

4 (10.3)

0 (0.0)

0 (0.0)

0 (0.0)

   Pyrexia

2 (5.1)

2 (5.1)

0 (0.0)

0 (0.0)

   Dysuria**

1 (2.6)

1 (2.6)

0 (0.0)

0 (0.0)

   Stomatitis*

4 (10.3)

16 (41.0)

1 (2.6)

0 (0.0)

   PPE Syndrome*

3 (7.7)

10 (25.6)

6 (15.4)

0 (0.0)

   Mucosal Inflammation*

8 (20.5)

11 (28.2)

0 (0.0)

0 (0.0)

   Alopecia*

16 (41.0)

1 (2.6)

0 (0.0)

0 (0.0)

   Neuropathy*

3 (7.7)

2 (5.1)

2 (5.1)

0 (0.0)

   Pain in Extremity*

2 (5.1)

3 (7.7)

3 (7.7)

0 (0.0)

   Erythema*

5 (12.8)

2 (5.1)

0 (0.0)

0 (0.0)

   Dry Skin*

2 (5.1)

2 (5.1)

0 (0.0)

0 (0.0)

   Pruritus*

3 (7.7)

0 (0.0)

0 (0.0)

0 (0.0)

   Gingivitis*

1 (2.6)

1 (2.6)

0 (0.0)

0 (0.0)

   Dermatitis*

0 (0.0)

1 (2.6)

1 (2.6)

0 (0.0)

   Pigmentation Disorder*

1 (2.6)

1 (2.6)

0 (0.0)

0 (0.0)

   Flushing*

2 (5.1)

0 (0.0)

0 (0.0)

0 (0.0)

  1. *Related to pegylated liposomal doxorubicin only
  2. **Related to canfosfamide only