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Table 4 Serious adverse events and adverse events

From: Platelet-rich plasma in Achilles tendon healing 2 (PATH-2) trial: statistical analysis plan for a multicentre, double-blinded, parallel-group, placebo-controlled randomised clinical trial

Serious adverse events An untoward medical occurrence that: • Results in death • Is life-threatening • Requires in-patient hospitalisation or prolongation of existing hospitalisation • Results in persistent or significant disability/incapacity • Leads to a congenital anomaly/birth defect • Other important medical events
Adverse events (related to study treatment or condition that do not require specific time-critical reporting but may be collected as part of standard data collection in the PATH-2 trial) Foreseeable adverse events • Bruising and discomfort at the venesection site • Mild discomfort or minor bleeding from ATR site following injection • Technical complications of the lower leg casting and splinting • Consequences of depending on walking aids • Syncopal (fainting) episode associated with venesection or tendon injection • Discomfort at ATR site during rehabilitation • Swelling or bruising of the lower leg and foot • Deep vein thrombosis in a lower limb • Re-rupture of the treated Achilles tendon (including any surgery on the Achilles tendon treated in the study) Unforeseeable adverse events • Serious infection of ATR injection site • Skin breakdown or ulceration of treated lower leg other than ‘plaster sores’ • Severe pain requiring more than simple analgesia beyond 10 days after injection Other adverse events not pre-specified but deemed related to treatment or condition will also be recorded and reported