Table 9 |
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|
Number (%) of patients with the most commonly reported system organ classes in the treatment and extension periods, safety population. |
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|
System organ class |
Treatment period |
Extension period |
||
|
|
||||
|
PRM(n = 394) |
Placebo(n = 395) |
PRM(n = 534) |
Placebo(n = 177) |
|
|
|
||||
|
Infections and infestations |
38 (9.6) |
43 (10.9) |
176 (33.0) |
60 (33.9) |
|
Gastrointestinal disorders |
18 (4.6) |
31 (7.8) |
113 (21.2) |
37 (20.9) |
|
Musculoskeletal and connective tissue disorders |
21 (5.3) |
21 (5.3) |
113 (21.2) |
34 (19.2) |
|
Nervous system disorders |
19 (4.8) |
23 (5.8) |
47 (8.8) |
19 (10.7) |
|
Respiratory, thoracic and mediastinal disorders |
12 (3.0) |
16 (4.1) |
47 (8.8) |
18 (10.2) |
|
Skin and subcutaneous tissue disorders |
12 (3.0) |
9 (2.3) |
43 (8.1) |
13 (7.3) |
|
Injury, poisoning and procedural complications |
8 (2.0) |
2 (0.5) |
35 (6.6) |
13 (7.3) |
|
Renal and urinary disorders |
9 (2.3) |
4 (1.0) |
29 (5.4) |
7 (4.0) |
|
General disorders and administration site disorders |
5 (1.3) |
5 (1.3) |
28 (5.2) |
16 (9.0) |
|
Investigations |
5 (1.3) |
7 (1.8) |
24 (4.5) |
9 (5.1) |
|
Eye disorders |
5 (1.3) |
1 (0.3) |
20 (3.7) |
6 (3.4) |
|
Psychiatric disorders |
5 (1.3) |
4 (1.0) |
17 (3.2) |
13 (7.3) |
|
Vascular disorders |
2 (0.5) |
0 (0) |
16 (3.0) |
5 (2.8) |
|
Cardiac disorders |
0 (0) |
1 (0.3) |
15 (2.8) |
2 (1.1) |
|
Ear and labyrinth disorders |
0 (0) |
1 (0.3) |
13 (2.4) |
2 (1.1) |
|
Reproductive system and breast disorders |
3 (0.8) |
3 (0.8) |
12 (2.2) |
1 (0.6) |
|
Metabolism and nutrition disorders |
1 (0.3) |
2 (0.5) |
7 (1.3) |
4 (2.3) |
|
Surgical and medical procedures |
1 (0.3) |
2 (0.5) |
7 (1.3) |
6 (3.4) |
|
|
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|
PRM, prolonged release melatonin. |
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|
Wade et al. BMC Medicine 2010 8:51 doi:10.1186/1741-7015-8-51 |
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