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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