Table 4.
Data on Adverse Events and Percentage of Intent-to-Treat Sample for All Adverse Events Occurring for at Least 5% of the Participants in Any Treatment Group
| Treatment Group | ||||||
|---|---|---|---|---|---|---|
| Placebo | 20 IU of Insulin | 40 IU of Insulin | ||||
| Adverse Event | Events, No. | Sample, % | Events, No. | Sample, % | Events, No. | Sample, % |
| Light-headedness and/or dizziness | 3 | 10.0 | 3 | 8.3 | 5 | 13.2 |
| Headache not related to lumbar puncture | 1 | 3.3 | 4 | 8.3 | 2 | 5.3 |
| Nose bleed | 0 | 0.0 | 6 | 8.3 | 3 | 2.6 |
| Rhinitis | 1 | 3.3 | 8 | 16.7 | 4 | 7.9 |
| Upper respiratory tract infection | 2 | 6.7 | 2 | 5.6 | 1 | 2.6 |
| Fall | 2 | 6.7 | 1 | 2.8 | 1 | 2.6 |
| Rash | 2 | 6.7 | 1 | 2.8 | 2 | 2.6 |
| Other | 16 | 46.7 | 30 | 58.3 | 33 | 60.5 |
| Total | 27 | 56.7 | 55a | 72.2 | 51b | 68.4 |
P < .05 for comparison of 20-IU dose insulin group vs placebo group.
P < .10 for comparison of 40-IU dose insulin group vs placebo group.