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