Table 2.
Summary of unexpected adverse events (AEs) in the two patient groups.
| Unexpected Adverse event | NFII group (n=207) | CIP group (n=209) | p-Value | ||||
|---|---|---|---|---|---|---|---|
| Episodes | Patients | % | Episodes | Patients | % | ||
| All adverse events | 14 | 11 | 5.31 | 9 | 7 | 3.35 | 0.3468 |
| Related to the device | 0 | 0 | 0.00 | 0 | 0 | 0.00 | 1.0000 |
| Unrelated to the device | 14 | 11 | 5.31 | 9 | 7 | 3.35 | 0.3468 |
| AEs leading to treat-ment withdrawal | 1 | 1 | 0.48 | 0 | 0 | 0.00 | 0.4976 |
| Severe adverse events (bone disorders) | 2 | 2 | 0.97 | 0 | 0 | 0.00 | 0.2470 |
| Unexpected adverse events: | |||||||
| All adverse events | 14 | 11 | 5.31 | 9 | 7 | 3.35 | 0.3468 |
| Bone disorders | 3 | 3 | 1.45 | 0 | 0 | 0.00 | 0.1223 |
| Upper respiratory tract infection | 3 | 3 | 1.45 | 3 | 3 | 1.44 | 1.0000 |
| Fever | 2 | 2 | 0.97 | 0 | 0 | 0.00 | 0.2470 |
| Hyperuricemia | 1 | 1 | 0.48 | 0 | 0 | 0.00 | 0.4976 |
| Abnormal liver function test | 1 | 1 | 0.48 | 0 | 0 | 0.00 | 0.4976 |
| Disc disorder | 1 | 1 | 0.48 | 0 | 0 | 0.00 | 0.4976 |
| Bacterial infection | 1 | 1 | 0.48 | 0 | 0 | 0.00 | 0.4976 |
| Diarrhea | 1 | 1 | 0.48 | 2 | 2 | 0.96 | 1.0000 |
| Angina | 1 | 1 | 0.48 | 0 | 0 | 0.00 | 0.4976 |
| Joint disorder | 0 | 0 | 0.00 | 1 | 1 | 0.48 | 1.0000 |
| Virus infection | 0 | 0 | 0.00 | 1 | 1 | 0.48 | 1.0000 |
| Toothache | 0 | 0 | 0.00 | 1 | 1 | 0.48 | 1.0000 |
| Spastic paralysis | 0 | 0 | 0.00 | 1 | 1 | 0.48 | 1.0000 |