Characteristic |
RIO‐Lipids |
RIO‐Europe |
RIO‐North America |
RIO‐Diabetes |
[n] adverse events (T1/ T2 / C1 / total) |
407 / 367 / 340 / 1114 |
522 / 498 / 257 / 1277 |
1042 / 1013 / 498 / 2553 |
288 / 293 / 276 / 857 |
[%] adverse events (T1/ T2 / C1 / total) |
117.6 / 106.4 / 99.4 / 107.8 |
87.1 / 82.6 / 84.3 / 84.7 |
85.5 / 83.4 / 82.0 / 84.0 |
85 / 81.8 / 79.3 / 82 |
[n] nausea (T1/ T2 / C1 / total) |
44/ 25 / 11 / 80 |
77 / 31 / 13 / 121 |
117 / 69 / 29 / 215 |
41 / 22 / 20 / 83 |
[%] nausea (T1/ T2 / C1 / total) |
12.7 / 7.2 / 3.2 / 7.7 |
12.9 / 5.1 / 4.3 / 8.0 |
11.2 / 6.8 / 5.8 / 7.1 |
12.1 / 6.1 / 5.7 / 7.9 |
[n] dizziness (T1/ T2 / C1 / total) |
36 / 29 / 23 / 88 |
52 / 42 / 15 / 109 |
58 / 46 / 20 / 114 |
31 / 11 / 17 / 59 |
[%] dizziness (T1/ T2 / C1 / total) |
10.4 / 8.4 / 6.7 / 8.5 |
8.7 / 7.0 / 4.9 / 7.2 |
5.6 / 4.5 / 4.0 / 4.1 |
9.1 / 3.1 / 4.9 / 5.6 |
[n] serious adverse events (T1/ T2 / C1 / total) |
15 / 19 / 10 / 44 |
52 / 45 / 23 / 120 |
55 / 46 / 21 / 122 |
27 / 27 / 15 / 69 |
[%] serious adverse events (T1/ T2 / C1 / total) |
4.3 / 5.5 / 2.9 / 4.3 |
8.7 / 7.5 / 7.5 / 8.0 |
4.5 / 3.8 / 3.5 / 4.0 |
8.0 / 7.5 / 4.3 / 6.6 |
[n] psychiatric disorders (T1/ T2 / C1 / total) |
1/ 1 / 1 / 3 |
9 / 2 / 1 / 12 |
76 / 44 / 14 / 134 |
? |
[%] psychiatric disorders (T1/ T2 / C1 / total) |
0.3 / 0.3 / 0.3 / 0.3 |
1.5 / 0.3 / 0.3 / 0.8 |
6.2 / 3.6 / 2.3 / 4.4 |
? |
[n] nervous system disorders (T1/ T2 / C1 / total) |
2 / 0 / 2 / 4 |
3 / 7 / 3 / 13 |
27 / 14 / 6 / 47 |
? |
[%] nervous system disorders (T1/ T2 / C1 / total) |
0.6 / 0 / 0.6 / 0.4 |
0.5 / 1.2 / 1.0 / 0.9 |
2.2 / 1.2 / 1.0 / 1.6 |
? |
[n] neoplasms (T1/ T2 / C1 / total) |
2 / 3 / 0 / 5 |
7 / 5 / 2 / 14 |
? |
? |
[%] neoplasms (T1/ T2 / C1 / total) |
0.6 / 0.9 / 0 / 0.5 |
1.2 / 0.8 / 0.7 / 0.9 |
? |
? |
[n] discontinuation due to adverse events (T1/ T2 / C1 / total) |
52 / 29 / 24 / 105 |
87 / 50 / 28 / 165 |
156 / 114 / 44 / 314 |
51 / 28 / 19 / 98 |
[%] discontinuation due to adverse events (T1/ T2 / C1 / total) |
15.0 / 8.4 / 7.0 / 10.2 |
14.5 / 8.3 / 9.2 / 10.9 |
12.8 / 9.4 / 7.2 / 10.3 |
15.0 / 7.8 / 5.5 / 9.4 |
[n] hospitalisation (T1/ T2 / C1 / total) |
? |
? |
? |
? |
[%] hospitalisation (T1/ T2 / C1 / total) |
? |
? |
? |
? |
[n] out‐patient treatment (T1/ T2 / C1 / total) |
NA |
NA |
NA |
NA |
[%] out‐patient treatment (T1/ T2 / C1 / total) |
NA |
NA |
NA |
NA |
[n] hypoglycaemic episodes (T1/ T2 / C1 / total) |
NA |
NA |
NA |
NA |
[%] hypoglycaemic episodes (T1/ T2 / C1 / total) |
NA |
NA |
NA |
NA |
[n] severe hypoglycaemic episodes (T1/ T2 / C1 / total) |
NA |
NA |
NA |
NA |
[%] severe hypoglycaemic episodes (T1/ T2 / C1 / total) |
NA |
NA |
NA |
NA |
[n] nocturnal hypoglycaemic episodes (T1/ T2 / C1 / total) |
NA |
NA |
NA |
NA |
[%] nocturnal hypoglycaemic episodes (T1/ T2 / C1 / total) |
NA |
NA |
NA |
NA |
[n] with symptoms (T1/ T2 / C1 / total) |
NA |
NA |
NA |
NA |
[%] with symptoms (T1/ T2 / C1 / total) |
NA |
NA |
NA |
NA |
Notes |
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Symbols: unclear=? |
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Abbreviations: T=treatment, C=control, NA=not applied |
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