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Table 3 Summary of grade 3 and/or 4 specific adverse events reported in >1% patients across randomised controlled trials

From: Efficacy and safety of pharmacological interventions in second- or later-line treatment of patients with advanced soft tissue sarcoma: a systematic review

AEs by class

PALETTE study 2011#

Demetri 2009

GEIS study 2011

Pautier 2009

Pacey 2011*

van Oosterom 2002

 

Pazopanib, n (%)

Placebo, n (%)

Trabectedin 1.5 mg/m2 q3w, n (%)

Trabectedin 0.58 mg/m2 qw, n (%)

Dacarbazine, n (%)

Gemcitabine + Dacarbazine, n (%)

Gemcitabine, n (%)

Gemcitabine + Docetaxel, n (%)

Placebo, n (%)

Sorafenib, n (%)

Ifosfamide 5 g/m2/day, n (%)

Ifosfamide 3 g/m2/day, n (%)

Evaluable N

240

123

130

130

52

57

-

-

2

2

27

31

GI disorders

 Abdominal pain

0 (0.0)

0 (0.0)

6 (4.6)

6 (4.6)

-

-

-

-

-

-

-

-

 Constipation

1 (0.4)

3 (2.4)

0 (0.0)

2 (1.5)

-

-

-

-

-

-

-

-

 Diarrhoea

11 (4.6)

1 (0.8)

1 (0.8)

0 (0.0)

0 (0.0)

0 (0.0)

-

-

-

-

-

-

 GI pain

6 (2.5)

5 (4.1)

-

-

-

-

-

-

-

-

-

-

 Mucositis/stomatitis

1 (0.4)

0 (0.0)

-

-

0 (0.0)

1 (1.8)

-

-

-

-

-

-

 Nausea

8 (3.3)

2 (1.6)

7 (5.4)

3 (2.3)

1 (1.9)~

0 (0.0)~

-

-

-

-

-

-

 Nausea/vomiting

-

-

-

-

-

-

-

-

-

-

0 (0.0)$

-

 Vomiting

8 (3.3)

1 (0.8)

7 (5.4)

2 (1.5)

0 (0.0)~

1 (1.8)~

-

-

-

-

-

-

 Small intestinal obstruction

3 (1.3)

0 (0.0)

-

-

-

-

-

-

-

-

-

-

General disorders

 Asthenia

0 (0.0)

0 (0.0)

-

-

5 (9.6)~

4 (7.0)~

-

-

-

-

 

-

 Back pain

-

-

4 (3.1)

4 (3.1)

-

-

-

-

-

-

-

-

 Fatigue

33 (13.7)

6 (4.9)

10 (7.7)

9 (6.9)

-

-

-

-

-

-

-

-

 Peripheral oedema

5 (2.1)

2 (1.6)

-

-

-

-

-

-

-

-

-

-

 Chest pain

4 (1.7)

0 (0.0)

          

Skin and subcutaneous tissues disorders

 Skin disorder

4 (1.7)

0 (0.0)

-

-

-

-

-

-

-

-

-

-

Investigations

 ALT increased

23 (9.6)

4 (3.3)

62 (47.7)

12 (9.2)

-

-

-

-

0 (0.0)

0 (0.0)

-

-

 Alkaline phosphatase

7 (2.9)

1 (0.8)

2 (1.5)

3 (2.3)

-

-

-

-

-

-

-

-

 AST increased

19 (7.9)

2 (1.6)

41 (31.5)

4 (3.1)

-

-

-

-

0 (0.0)

0 (0.0)

-

-

 Creatinine increased

1 (0.4)

0 (0.0)

3 (2.3)

1 (0.8)

-

-

-

-

-

-

-

-

 Creatinine phosphokinase

-

-

7 (5.4)

12 (9.2)

-

-

-

-

-

-

-

-

 Bilirubin increased

3 (1.3)

2 (1.6)

1 (0.8)

1 (0.8)

-

-

-

-

0 (0.0)

0 (0.0)

-

-

 Gamma-glutamyltransferase

4 (1.7)

0 (0.0)

-

-

-

-

-

-

-

-

-

-

 Weight loss

9 (3.8)

0 (0.0)

-

-

-

-

-

-

0 (0.0)

0 (0.0)

-

-

 ENT examination abnormal

4 (1.7)

0 (0.0)

-

-

-

-

-

-

-

-

-

-

 Hypoalbuminemia

-

-

-

-

-

-

-

-

0 (0.0)

0 (0.0)

-

-

Hemorrhagic events

 Hemorrhagic event (any)

5 (2.0)

2 (1.6)

-

-

-

-

-

-

0 (0.0)

0 (0.0)

-

-

Metabolism and nutrition disorders

 Decreased appetite

14 (5.9)

0 (0.0)

1 (0.8)

0 (0.0)

-

-

-

-

-

-

-

-

 Dehydration

3 (1.4)

0 (0.0)

-

-

-

-

-

-

-

-

-

-

Musculoskeletal and connective tissue disorders

 Arthralgia/myalgia

5 (2.1)

0 (0.0)

-

-

-

-

-

-

0 (0.0)

0 (0.0)

-

-

 Musculoskeletal pain

5 (2.1)

2 (1.6)

-

-

-

-

-

-

-

-

-

-

Respiratory, thoracic, and medistinal disorders

 Dyspnoea

15 (6.3)

7 (5.7)

5 (3.8)

8 (6.2)

-

-

-

-

-

-

-

-

 Pleural effusion

5 (2.1)

0 (0.0)

-

-

-

-

-

-

-

-

-

-

Blood and lymphatic system disorders

 Anaemia

15 (6.3)

2 (1.6)

10 (7.7)

12 (9.2)

6 (11.5)

2 (3.5)

-

-

-

-

-

-

 Febrile neutropenia

-

-

-

-

3 (5.8)

5 (8.8)

-

-

-

-

-

-

 Leukopenia

3 (1.3)

0 (0.0)

-

-

16 (30.8)

15 (26.3)

-

-

-

-

-

-

 Neutropenia

10 (4.2)

0 (0.0)

61 (46.9)

17 (13.1)

17 (32.7)

27 (47.4)

-

-

-

-

-

-

 Thrombocytopenia

9 (3.8)

0 (0.0)

15 (11.5)

7 (5.4)

14 (26.9)

3 (5.3)

-

-

-

-

0 (0.0)$

-

 Lymphopenia

23 (9.6)

13 (10.6)

-

-

-

-

-

-

-

-

-

-

Cardiac disease

 Hypertension

16 (6.7)

0 (0.0)

-

-

-

-

-

-

-

-

-

-

 Myocardial/LVEF Dysfunction

4 (1.7)

0 (0.0)

-

-

-

-

-

-

-

-

-

-

Other disorders

 Tumour pain

20 (8.3)

9 (7.3)

          

 Non-haemotological

-

-

-

-

-

-

-

2¶

-

-

-

-

  1. The data for the PALETTE study is likely to be more comprehensive than for the other studies since extracted from the CSR versus published reports for the other studies; AE: Adverse Events; ALT: Alanine Transaminase; AST: Aspartate Aminotransferase; GI: Gastrointestinal; N: Number of Patients; n: Number with Outcome; q3w: Every Three Weeks; qw: Every Week; *Grade 3–5 AEs are reported in Pacey 2011 trial; #Data reported for haematology and liver enzyme abnormalities in PALETTE study by maximum grade shift (any increase in grade) based on clinical laboratory evaluations; all other data for PALETTE based on AE reports; -Represents data not reported; $Represents Grade 4 event; ~Represents Grade 3 event; ¶ Number of patients analysed was not reported and hence, percentage of patients could not be computed.
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BMC Cancer

ISSN: 1471-2407

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