Intravenous Oxycodone versus Intravenous Morphine in Cancer Pain: A Randomized, Open-Label, Parallel-Group, Active-Control Study
Table 3
Incidence of adverse events.
Safety set
Oxycodone (N = 34)
Morphine (N = 32)
value (χ2 test)
Incidence, n (%)
95% CI§
No. of events
Incidence, n (%)
95% CI§
No. of events
(lower limit, upper limit)
(lower limit, upper limit)
Adverse events
29 (85.3)
(68.9, 95.1)
64
26 (81.3)
(63.6, 92.8)
58
0.660
(i) Gastrointestinal disorders
22 (64.7)
(17.4, 50.5)
30
16 (50.0)
(9.3, 40.0)
23
—
(ii) Nervous system disorders
7 (20.6)
(6.7, 34.5)
7
5 (15.6)
(3.5, 29.0)
5
—
(iii) General disorders and administration site
6 (17.7)
(0.0, 10.3)
7
6 (18.8)
(0.0, 16.2)
6
—
(iv) Skin and subcutaneous tissue disorders
5 (14.7)
(0.1, 15.3)
5
4 (12.5)
(0.8, 20.8)
4
—
(v) Other disorders
15 (44.1)
—
15
16 (50.0)
—
20
—
Unexpected adverse events
9 (26.5)
(12.9, 44.4)
12
16 (50.0)
(31.9, 68.1)
29
0.049
(i) Blood and lymphatic system disorders
3 (8.8)
(1.9, 23.7)
3
1 (3.1)
(0.1, 16.2)
1
—
(ii) Gastrointestinal disorders
2 (5.9)
(0.7, 16.7)
2
5 (15.6)
(5.3, 32.8)
5
—
(iii) Metabolism and nutrition disorders
2 (5.9)
(0.7, 19.7)
2
2 (6.3)
(0.8, 20.8)
3
—
(iv) Injury, poisoning, and procedural complications
2 (5.9)
(0.7, 19.7)
2
0
(0.0, 10.9)
0
—
(v) Respiratory, thoracic, and mediastinal disorders
1 (2.9)
(0.1, 15.3)
1
4 (12.5)
(3.5, 29.0)
5
—
(vi) Infections and infestations
1 (2.9)
(0.1, 15.3)
1
2 (6.3)
(0.8, 20.8)
2
—
(vii) Investigations
1 (2.9)
(0.1, 15.3)
1
1 (3.1)
(0.1, 16.2)
3
—
(viii) General disorders and administration site
0
(0.0, 10.3)
0
5 (15.6)
(5.3, 32.8)
5
—
(ix) Renal and urinary disorders
0
(0.0, 10.3)
0
3 (9.4)
(2.0, 25.0)
3
—
(x) Other disorders
0
—
0
2 (6.3)
—
2
—
Dropouts
2 (5.9)
(0.7, 19.7)
7
0 (0.0)
(0.0, 10.9)
0
0.493†
Serious adverse events
3 (8.8)
(1.9, 23.7)
3
2 (6.3)
(0.8, 20.8)
2
>0.999†
Adverse drug reaction‡
14 (41.2)
(24.7, 59.3)
20
11 (34.4)
(18.6, 53.2)
17
0.569
Serious adverse drug reaction
0 (0.0)
(0.0, 10.3)
0
0 (0.0)
(0.0, 10.9)
0
—
Unexpected adverse drug reaction
0 (0.0)
(0.0, 10.3)
0
1 (3.1)
(0.1, 16.2)
1
0.485†
Dropouts caused by adverse events are subjects whose reason for dropout was “difficult to perform the study due to AE or SAE”; †exact test; §the 95% CI was calculated using the exact method; ‡adverse drug reactions are adverse events collected as “certain,” “probable/likely,” “possible,” “conditional/unclassified,” or “unassessable/unclassifiable” for the causal relationship to the study drug.
