Adverse Events

Adverse events are defined as unfavourable or unintended treatment-associated signs, symptoms, or diseases regardless of causality. Adverse events were assessed in 19 trials with 3,289 patients, but reporting quality varied. No statistically significant group differences were observed across reported specific adverse effects, but the certainty of adverse event evidence was low. Adverse events are treated as events of scientific interest because they can be clearly connected to the treatment or medical condition under investigation. Patient survival is documented at every follow-up visit and confirmed by phone if a visit is missed. Reported adverse events with TXL included abdominal discomfort, gastrointestinal symptoms, and breathlessness. Examples of adverse events include increased local pain, dizziness, vasovagal response, or dyspnoea during or immediately after treatment. The observational registry documents only anticipated condition-related, treatment-related, or implant-related adverse events from consent onward. Documented adverse events include implant fixation failure, wound complications, neurological events, bleeding, ankylosis, malocclusion, material sensitivity, hete…