Patients
| |
Sex
| |
Female
|
76 (71.7)
|
Male
|
30 (28.3)
|
Age [y], mean (SD) [min – max]
|
38.5 (18.4) [8 – 80]
|
<15
|
11 (10.4)
|
15-30
|
26 (24.5)
|
31-60
|
49 (46.2)
|
>60
|
11 (10.4)
|
N/A
|
9 (8.5)
|
History of drug allergy
| |
No
|
93 (87.7)
|
Yes
|
12 (11.3)
|
N/A
|
1 (1.0)
|
Adverse event reports
| |
Source of reports
| |
Spontaneous
|
95 (89.6)
|
Intensive
|
11 (10.4)
|
Seriousness
| |
Serious
|
18 (17.0)
|
Hospitalization or prolongation of hospitalization
|
16
|
Life threatening
|
2
|
Non-serious
|
88 (83.0)
|
Causality assessmentb
| |
Certain
|
8 (7.5)
|
Probable
|
61 (57.6)
|
Possible
|
33 (31.1)
|
Unlikely
|
0 (0.0)
|
N/A
|
4 (3.8)
|
No. of concomitant drug, mean (SD) [min – max]
|
0.4 (0.8) [0 – 4]
|
None
|
82 (77.4)
|
1item
|
13 (12.3)
|
2items
|
7 (6.6)
|
3items
|
3 (2.8)
|
≥4items
|
1 (0.9)
|
Time of exposure (day), mean (SD) [min – max]
|
1.2 (3.4) [0 – 30]
|
1 day
|
51 (48.1)
|
2 days
|
20 (18.9)
|
3 days
|
14 (13.2)
|
≥4 days
|
8 (7.6)
|
N/Ac
|
13 (12.2)
|
Time to onset (day), mean (SD) [min – max]
|
0.8 (1.6) [0 – 8]
|
First day of use
|
61 (57.6)
|
2daysof use
|
24 (22.6)
|
3 days of use
|
15 (14.2)
|
≥4 days of use
|
5 (4.7)
|
N/A
|
1 (0.9)
|