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Table 5 Adverse event reporting

From: Co-designed neck exercise (EPIC-Neck) vs usual exercise care for people with chronic non-specific neck pain: protocol for a randomised feasibility study with process evaluation

Term

Definition

Related event

Any non-serious untoward medical occurrence which a participant experiences to whom an intervention (experimental or control) has been administered, that is, or possibly caused by or related to the intervention,

e.g. temporary increases in neck pain symptoms and delayed-onset muscle soreness

Serious adverse event (SAE)

Any serious untoward medical occurrence which a participant experiences to whom an intervention (experimental or control) has been administered, that is not caused by or related to the intervention

Serious related event

Any serious untoward medical occurrence which a participant experiences to whom an intervention (experimental or control) has been administered, that is, or possibly caused by or related to the intervention and is consistent with the available information (i.e. expected)

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Pilot and Feasibility Studies

ISSN: 2055-5784