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Adverse Events.
| Adverse Event | Placebo (N = 78) | Ivacaftor (N = 83) |
|---|---|---|
| no. of subjects (%) | ||
| Any adverse event | 78 (100) | 82 (99) |
|
| ||
| Serious adverse event* | 33 (42) | 20 (24) |
|
| ||
| Pulmonary exacerbation | 26 (33) | 11 (13) |
|
| ||
| Hemoptysis | 4 (5) | 1 (1) |
|
| ||
| Hypoglycemia | 0 | 2 (2) |
|
| ||
| Adverse event leading to study-drug interruption | 5 (6) | 11 (13) |
|
| ||
| Adverse event leading to study-drug discontinuation | 4 (5) | 1 (1) |
Included are serious adverse events that occurred in more than one subject per group.
