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 |
||||
|
Vakhapova et al. BMC Neurology 2011 11:79 doi:10.1186/1471-2377-11-79 |
||||
