Table 7

Adverse events reported during the course of the open-label extension*

PS-DHA continuers

PS-DHA naive**


Adverse event

Number of related or probably related adverse events

Number of not-related or probably not related adverse events

Number of not-related or probably not related adverse events


Gastrointestinal discomfort

1

3


Hypertension

1

3


Hypotension

1


Fall

1


Tenesmus

1


Amaurosis fugax

1


Mild bleeding due to Hemorrhoids

1


Platelets decrease

1


Hand Fracture

1


Hyperlipidemia

1


Dizziness

1


Urinal tract infection

1


Arm pigmentation

1


Headache

1

1


SUM

3 events in 3 participants

9 events in 7 participants

9 events in 6 participants


* Judged by the study physicians as related, probably related, not related or probably not related to the study treatment

** There were no adverse events classified by the study physicians as related or probably related to the study treatment

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

Open Data