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

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