Adverse event reporting and harms {22}
dysphagia, pneumonitis, nausea, fatigue, fibrosis, odynophagia, pain, fistula, dyspnoea, stenosis
DYSPHAGIA, PNEUMONITIS, ADVERSE EVENTS, RESPIRATORY FAILURE, EVENT, FIBROSIS, SLEEP APNOEA, ADVERSE EFFECTS, OESOPHAGITIS, STENOSIS
The principal investigator and sub-investigators will report adverse events to the Radiation Safety Officer on site and to the Human Research Ethics Committee and the Research Governance Officer within 72 hours of the event occurring unless immediate notification is required.Radiation therapy has known potential adverse effects. No additional adverse events are expected related to the introduction of new technology in the Breathe Well arm. The following are the known potential adverse events to radiotherapy of the breast: pneumonitis, radiation fibrosis, dyspnoea, dysphagia, odynophagia, pleuritic pain, oesophagitis, fistula, respiratory failure, sleep apnoea, fatigue, stenosis, lung function, nausea, sexual function.