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Table 5 ADRs (active treatment) - by SOC/PT, by treatment group and overall

From: Dexketoprofen/tramadol 25 mg/75 mg: randomised double-blind trial in moderate-to-severe acute pain after abdominal hysterectomy

System organ class

DKP/TRAM N = 203

DKP N = 202

TRAM N = 201

Overall N = 606

Preferred term

Gastrointestinal disorders

13 (6.4 %) | 14

17 (8.4 %) | 18

20 (10 %) | 27

50 (8.3 %) | 59

 Nausea

8 (3.9 %) | 9

7 (3.5 %) | 7

13 (6.5 %) | 13

28 (4.6 %) | 29

 Vomiting

2 (1.0 %) | 2

6 (3.0 %) | 6

6 (3.0 %) | 6

14 (2.3 %) | 14

 Abdominal distension

2 (1.0 %) | 2

1 (0.5 %) | 1

6 (3.0 %) | 6

9 (1.5 %) | 9

 Abdominal pain upper

–

2 (1.0 %) | 2

–

2 (0.3 %) | 2

 Constipation

1 (0.5 %) | 1

–

1 (0.5 %) | 1

2 (0.3 %) | 2

 Dyspepsia

–

2 (1.0 %) | 2

1 (0.5 %) | 1

3 (0.5 %) | 3

Investigations

2 (1.0 %) | 3

11 (5.4 %) | 17

4 (2.0 %) | 4

17 (2.8 %) | 24

 Platelet count increased

–

4 (2.0 %) | 4

4 (2.0 %) | 4

8 (1.3 %) | 8

 Blood lactate dehydrogenase increased

1 (0.5 %) | 1

5 (2.5 %) | 5

–

6 (1.0 %) | 6

 Gamma-glutamyltransferase increased

1 (0.5 %) | 1

3 (1.5 %) | 3

–

4 (0.7 %) | 4

 Alanine aminotransferase increased

–

2 (1.0 %) | 2

–

2 (0.3 %) | 2

 Blood alkaline phosphatase increased

1 (0.5 %) | 1

1 (0.5 %) | 1

–

2 (0.3 %) | 2

 Aspartate aminotransferase increased

–

1 (0.5 %) | 1

–

1 (0.2 %) | 1

 Hepatic enzyme increased

–

1 (0.5 %) | 1

–

1 (0.2 %) | 1

Blood and lymphatic system disoders

1 (0.5 %) | 1

1 (0.5 %) | 1

1 (0.5 %) | 1

3 (0.5 %) | 3

 Thrombocytosis

1 (0.5 %) | 1

1 (0.5 %) | 1

1 (0.5 %) | 1

3 (0.5 %) | 3

Vascular disorders

2 (1.0 %) | 3

–

–

2 (0.3 %) | 3

 Hypertension

1 (0.5 %) | 2

–

–

1 (0.2 %) | 2

 Hypertensive crisis

1 (0.5 %) | 1

–

–

1 (0.2 %) | 1

Cardiac disorders

1 (0.5 %) | 1

1 (0.5 %) | 1

–

2 (0.3 %) | 2

 Tachycardia

1 (0.5 %) | 1

1 (0.5 %) | 1

–

2 (0.3 %) | 2

Nervous system disorders

–

1 (0.5 %) | 1

1 (0.5 %) | 1

2 (0.3 %) | 2

 Dizziness

–

1 (0.5 %) | 1

–

1 (0.2 %) | 1

 Headache

–

–

1 (0.5 %) | 1

1 (0.2 %) | 1

Psychiatric disorders

1 (0.5 %) | 1

1 (0.5 %) | 1

–

2 (0.3 %) | 2

 Insomnia

–

1 (0.5 %) | 1

–

1 (0.2 %) | 1

 Psychotic disorder

1 (0.5 %) | 1

–

–

1 (0.2 %) | 1

Skin and subcutaneous tissue disorders

1 (0.5 %) | 1

–

1 (0.5 %) | 1

2 (0.3 %) | 2

 Pruritus

–

–

1 (0.5 %) | 1

1 (0.2 %) | 1

 Urticaria

1 (0.5 %) | 1

–

–

1 (0.2 %) | 1

Ear and labyrinth disorders

–

–

1 (0.5 %) | 1

1 (0.2 %) | 1

 Vertigo

–

–

1 (0.5 %) | 1

1 (0.2 %) | 1

General disorders and administration site conditions

1 (0.5 %) | 1

–

–

1 (0.2 %) | 1

 Asthenia

1 (0.5 %) | 1

–

–

1 (0.2 %) | 1

Metabolism and nutrition disorders

1 (0.5 %) | 1

–

–

1 (0.2 %) | 1

 Hypokalaemia

1 (0.5 %) | 1

–

–

1 (0.2 %) | 1

Overall

19 (9.4 %) | 26

30 (15 %) | 39

27 (13 %) | 35

76 (13 %) | 100

  1. ADR adverse drug reaction, SOC system organ class, PT preferred term, DKP/TRAM dexketoprofen trometamol/tramadol hydrochloride 25 mg/75 mg, DKP dexketoprofen trometamol 25 mg, TRAM tramadol hydrochloride 100 mg, N number of patients. “Active treatment” refers to events arising after first dose of active drug intake (i.e. DKP|TRAM, DKP or TRAM); Results are expressed as number of patients (% of exposed) | number of events
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BMC Anesthesiology

ISSN: 1471-2253

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