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Table 3 (Serious) adverse events collected at 6-month intervals after randomisation, including serious adverse events, diagnoses and symptoms of low iron

From: The INTERVAL trial to determine whether intervals between blood donations can be safely and acceptably decreased to optimise blood supply: study protocol for a randomised controlled trial

Type of adverse event

Description

Data collected at 6, 12, 18 and 24 months

Serious adverse events, diagnosed/

treated at hospital or by a doctor

Heart problems including heart attack, stroke, mini-stroke, angina, heart failure

Falls

Transport accidents (when in charge of a vehicle)

New illness

Diagnoses of low iron

Diagnosis of low haemoglobin by NHSBT

Diagnosis of anaemia by general practitioner (GP) or hospital

Prescription of iron supplements

Symptoms

Tiredness

Dizziness

Feeling faint

Fainting

Fit or seizure

Breathlessness

Palpitations

Chest pain

Restless legs [22]

Additional data collected at 24 months

Symptoms

Severity of breathlessness [23]

Severity of palpitations (that is, resulted in ECG?)

Severity of chest pain (that is, resulted in ECG?)

Headaches

Sleep disturbances

Irritability

Reduced ability to concentrate

Restlessness/inability to relax

Pica