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Table 2 Types of adverse events

From: Folate Augmentation of Treatment – Evaluation for Depression (FolATED): protocol of a randomised controlled trial

 

Adverse Events (AE)

Adverse Reactions (AR)

Serious Adverse Events (SAE)

Serious Adverse Reactions (SAR)

Suspected Unexpected Serious Adverse Reactions (SUSAR)

Is the medical occurrence considered to be related to trial drug?

N

Y

N

Y

Y

Is the medical occurrence serious?

N

N

Y

Y

Y

Is the medical occurrence unexpected?

N

N

N

N

Y

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BMC Psychiatry

ISSN: 1471-244X

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