Table 2 Relatedness and severity of reported adverse events

From: Efficacy and safety of using auditory-motor entrainment to improve walking after stroke: a multi-site randomized controlled trial of InTandemTM

Adverse event relatedness and severity

InTandem

Control

Not related

Mild

    covid (infected)

2

 

    covid vaccine

1

 

    fall

1

4

    headache

 

1

    hypertension

1

 

    pain

2

 

    tonsillitis

1

 

Moderate

    hospitalization

 

1a

Severe

    weakness

1a

 

Life-threatening

    seizures

 

1a

Unlikely related

Mild

    fall

1

 

Possibly related

Mild

    hypertension

1

 

Severe

    chest pain/diaphoresis/tachycardia

1a

 

Probably related

Mild

    pain

 

5

Grand total

12

12

  1. aDenotes ent (SAE)