Table 6.
Adverse events reported during the course of the double-blind phase*
| PS-DHA | Placebo | |||
|---|---|---|---|---|
| Adverse event | Number of related or probably related adverse events | Number of not-related or probably not related adverse events | Number of related or probably related adverse events | Number of not-related or probably not related adverse events |
| Adverse events among study drop-outs | ||||
| Gastrointestinal discomfort | 4 | 1 | ||
| Rush | 1 | |||
| Increased appetite and weight | 1 | |||
| Strange general feeling | 1 | |||
| Headache | 2 | |||
| dizziness | 2 | |||
| Mood swings | 1 | |||
| SUM | 5 events in 5 participants | 8 events in 5 participants | ||
| Adverse events among study completers | ||||
| Gastrointestinal discomfort | 9 | 3 | 1 | 2 |
| Weight loss | 1 | 1 | ||
| Gastritis | 1 | |||
| Headache | 1 | 1 | ||
| Pneumonia | 2 | |||
| Hypertension | 2 | 1 | ||
| Hypothyroidism | 1 | |||
| Back pain | 1 | |||
| Leg wound | 1 | |||
| Redness in the mouth | 1 | |||
| Pruritus | 1 | |||
| Eyes inflammation | 1 | |||
| SUM | 11 events in 5 participants | 13 events in 10 participants | 3 events in 3 participants | 4 events in 3 participants |
* Judged by the study physicians as related, probably related, not related or probably not related to the study treatment