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Table 6 Adverse events reported during the course of the double-blind phase*

From: Safety of phosphatidylserine containing omega-3 fatty acids in non-demented elderly: a double-blind placebo-controlled trial followed by an open-label extension

 

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

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