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Table 3 Adverse events associated with stroke, that do not have to be reported

From: Brain‐oscillation-synchronized stimulation to enhance motor recovery in early subacute stroke: a randomized controlled double‐blind three‐ arm parallel‐group exploratory trial comparing personalized, non‐ personalized and sham repetitive transcranial magnetic stimulation (Acronym: BOSS-STROKE)

a) Acute stroke-related deficits

New neurological deficits which may appear within several days after stroke

Abnormal gaze (partial gaze palsy, forced deviation)

Visual field (partial hemianopia, complete hemianopia, bilateral hemianopia)

Facial paresis (minor paresis, partial paresis, complete palsy)

Limb ataxia

Sensory deficits (pinpricks)

Dysarthria (mild to moderate, unintelligible)

Neglect (partial, complete)

Speech/comprehension deficits (mild to moderate aphasia, severe aphasia, mute)

Neurological deficits which may display post-stroke

Deterioration in level of consciousness

Deterioration of neurologic deficits, especially motor deficits

Complications due to stroke

Cerebral edema, cerebral incarceration

Need for external ventricular drainage or decompression surgery

b) Other Adverse Events (AEs)

 

AEs that are likely observed in stroke patients

• falls with subsequent fractures

• subsequent stroke or transitory ischemic attack

• heart infarction

• pneumonia

• urinary tract infection

• sepsis

• dehydration

• delirium