Skip to main content

Table 2 Drug-related adverse events reported during the entire treatment period (All patients, N = 28)

From: Once weekly paclitaxel associated with a fixed dose of oral metronomic cyclophosphamide: a dose-finding phase 1 trial

AE category

G 0

G 1

G 2

G 3

G 4

Total G ≥ 1

Total G ≥ 3

Blood And Lymphatic System Disorders

0

4

9

12

3

28

100.00%

15

53.57%

 Anemia

24

1

3

0

0

4

14.30%

0

0.00%

 Platelet Count Decreased

27

0

0

1

0

1

3.60%

1

3.60%

 Neutropenia

16

3

6

3

0

12

43.86%

3

10.71%

 Febrile Neutropenia

26

0

0

1

1

2

7.10%

2

7.10%

 Lymphocyte Count Decreased

0

6

10

10

2

28

100.00%

12

43.86%

Gastrointestinal Disorders

15

7

6

0

0

13

46.40%

0

0.00%

 Abdominal Pain

26

1

1

0

0

2

7.10%

0

0.00%

 Diarrhea

23

2

3

0

0

5

17.90%

0

0.00%

 Nausea

21

5

2

0

0

7

25.00%

0

0.00%

 Stomatitis

27

1

0

0

0

1

3.60%

0

0.00%

 Vomiting

26

2

0

0

0

2

7.10%

0

0.00%

General Disorders

13

7

6

2

0

15

53.60%

2

7.10%

 Fatigue

13

7

6

2

0

15

53.60%

2

7.10%

Metabolism And Nutrition Disorders

23

3

2

0

0

5

17.90%

0

0.00%

 Anorexia

25

2

1

0

0

3

10.70%

0

0.00%

 Hypoalbuminemia

27

0

1

0

0

1

3.60%

0

0.00%

 Weight Loss

27

1

0

0

0

1

3.60%

0

0.00%

Nervous System Disorders

15

9

3

1

0

13

46.43%

1

3.60%

 Dizziness

27

0

1

0

0

1

3.60%

0

0.00%

 Dysgeusia

26

2

0

0

0

2

7.10%

0

0.00%

 Peripheral Sensory/Motor Neuropathy*

16

8

3

1

0

12

43.86%

1

3.60%

Renal And Urinary Disorders

26

1

1

0

0

2

7.10%

0

0.00%

 Hematuria

26

1

1

0

0

2

7.10%

0

0.00%

Respiratory, Thoracic And Mediastinal Disorders

24

3

1

0

0

4

14.30%

0

0.00%

 Dyspnea

26

1

1

0

0

2

7.10%

0

0.00%

 Epistaxis

26

2

0

0

0

2

7.10%

0

0.00%

Skin And Subcutaneous Tissue Disorders

14

7

7

0

0

14

50.00%

0

0.00%

 Alopecia

14

7

7

0

0

14

50.00%

0

0.00%

 Dry Skin

26

2

0

0

0

2

7.10%

0

0.00%

  1. G 0: no AE; G 1: Grade 1 AE, G 2: Grade 2 AE, G 3: Grade 3 AE, G 4: Grade 4 AE, G 5: lethal AE
  2. For each category type, we considered the maximum grade per patient observed over the entire treatment duration
  3. All adverse events, classified as drug-related or not, are summarized in (Additional file 1: Table S1)
  4. *Myalgia has been pooled with peripheral sensory neuropathy because this symptom reflects more a peripheral neurotoxicity than a musculoskeletal disorder in the study setting