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Table 2 Treatment-Related Toxicities (Patient Number)

From: A randomized phase II trial of mitoxantrone, estramustine and vinorelbine or bcl-2 modulation with 13-cis retinoic acid, interferon and paclitaxel in patients with metastatic castrate-resistant prostate cancer: ECOG 3899

 

Arm A (n = 35)

Arm B (n = 35)

 

Arm A (n = 35)

Arm B (n = 35)

 

Grade

Grade

 

Grade

Grade

Toxicity Type

1, 2

3

4

1, 2

3

4

Toxicity Type

1, 2

3

4

1, 2

3

4

Allergic reaction

-

-

-

-

2

-

Stomatitis

5

-

-

6

1

-

Allergic rhinitis

1

-

-

1

-

-

Taste disturbance

6

-

-

4

-

-

Hemoglobin

31

3

1

28

5

-

Vomiting

10

-

-

9

1

-

Leukocytes

9

18

8

22

4

2

Diarrhea

5

2

-

11

-

-

Neutrophils

4

11

18

16

7

2

GI-other

2

-

-

-

-

-

Platelets

20

5

-

13

1

-

Hematuria

-

1

-

1

-

-

Transfusion:

-

1

-

-

4

-

Rectal bleeding

-

-

-

-

1

-

Sinus tachycardia

-

1

-

-

1

-

Alkaline phos

13

2

-

15

3

-

Supraventricular

-

-

-

-

1

-

Bilirubin

1

1

1

5

-

-

Cardiac-ischemia

-

-

-

1

-

-

Hypoalbuminemia

-

-

-

1

-

-

Cardiac-left vent

-

1

-

-

-

-

SGOT

7

-

-

10

1

-

Edema

9

-

-

4

-

-

SGPT

6

-

-

7

1

-

Hypertension

2

-

-

1

-

-

Febrile neutropenia

-

4

-

-

1

-

Hypotension

1

-

-

3

-

-

Infection w/neutro

-

1

1

-

-

-

Phlebitis

1

-

-

-

-

-

Infectionw/oneutro

2

 

-

1

1

-

Thrombosis/emb

-

6

1

-

1

-

Hypercalcemia

1

-

-

1

-

-

Fatigue

21

7

1

23

7

1

Hyperglycemia

2

1

-

3

1

-

Fever

-

-

-

7

1

-

Hyperkalemia

1

-

-

1

-

-

Rigors/chills

1

-

-

10

-

-

Hypertrig

6

-

-

22

1

-

Sweating

-

-

-

2

-

-

Hyponatremia

1

-

-

1

-

-

Weight gain

1

-

-

-

-

-

Metabolic-other

1

-

-

-

-

-

Weight loss

14

-

-

7

2

-

Muscle weakness

1

-

-

-

1

-

PTT

-

1

-

-

-

-

Ataxia

-

-

-

1

-

-

PT

1

1

-

-

-

-

Dizziness

3

-

-

3

-

-

Alopecia

8

-

-

11

-

-

Hallucinations

-

-

-

-

1

-

Bruising

2

-

-

-

-

-

Insomnia

2

-

-

7

-

-

Dry skin

1

-

-

3

-

-

Depression

4

1

-

2

-

-

Flushing

-

-

-

3

-

-

Euphoria

1

-

-

-

-

-

Injection site

2

-

-

-

-

-

Neuropathy-motor

2

-

-

1

-

-

Pruritus

2

-

-

-

-

-

Neuro-sensory

6

-

-

9

-

-

Rash

4

-

-

2

-

-

Vertigo

1

-

-

-

-

-

Skin-other

2

-

-

-

-

-

Neurologic-other

1

-

-

-

-

-

Gynecomastia

3

-

-

-

-

-

Tearing

1

-

-

-

-

-

Hot flashes

3

-

-

1

-

-

Blurred vision

1

-

-

3

-

-

Endocrine-other

-

-

-

1

-

-

Abdominal pain

2

-

-

-

-

-

Anorexia

16

1

-

14

2

-

Arthralgia

2

-

-

3

-

-

Constipation

12

1

-

8

-

-

Bone pain

1

-

-

5

-

-

Dehydration

-

1

-

2

1

-

Chest pain

1

-

-

-

-

-

Dyspepsia

3

-

-

-

-

-

Headache

2

-

-

8

-

-

Dysphagia

1

-

-

1

-

-

Myalgia

4

-

-

11

-

-

Flatulence

1

-

-

1

-

-

Pain-other

2

-

-

-

-

-

Mouth dryness

-

-

-

3

-

-

Cough

5

-

-

-

-

-

Nausea

21

-

-

18

1

-

Dyspnea

7

-

1

11

1

-

Sense of smell

1

-

-

-

-

-

Hypoxia

-

-

-

-

1

-

Creatinine/GU

8

-

1

3

-

2

Pulmonary-other

-

-

-

3

1

-