| | |
n (%)
|
n (%)
| |
|
Rare disease
|
Yes
|
27 (28.4)
|
13 (27.7)
|
0.92
|
|
Phase
|
2
|
28 (29.5)
|
18 (38.3)
|
0.87
|
|
2/3
|
2 (2.1)
|
0 (0)
| |
|
3
|
50 (52.6)
|
22 (46.8)
| |
|
Other
|
15 (15.8)
|
7 (14.9)
| |
|
Randomized
|
Yes
|
58 (61.1)
|
30 (63.8)
|
0.75
|
|
Double-blind
|
Yes
|
42 (44.2)
|
19 (40.4)
|
0.67
|
|
Clinical trials that included newborns or infants and toddlers
|
Yes
|
19 (20)
|
10 (21.7)
|
0.86
|
| | |
Median, min–max
|
Median, min–max
| |
|
Number of enrolled participants per age categories
|
All age categories including over 18 years
|
111, 1–4176
|
42, 6–1177
|
0.02
|
|
Newborn
|
0, 0–16
|
0, 0–4
|
0.43
|
|
Infant and toddler
|
0, 0–1229
|
0, 0–110
|
0.67
|
|
Child
|
2, 0–978
|
0, 0–506
|
0.07
|
|
Adolescent
|
8, 0–448
|
1, 0–327
|
0.03
|
|
Number of countries in which the clinical trial was conducted
| |
2, 1–10
|
4, 1–18
|
< 0.001
|
|
Year clinical trial started
|
2014
|
41 (43)
|
24 (51)
|
0.65
|
|
2015
|
32 (34)
|
10 (21)
| |
|
2016
|
16 (17)
|
10 (21)
| |
|
2017
|
6 (6.3)
|
3 (6.4)
| |
|
Trial period (days)
|
Final date–start date + 1
|
616, 130–1570
|
723.5, 81–1524
|
0.18
|
