Table 3 Adverse events of special interest (AESIs) and expected serious adverse events (ESAEs)
AESIs | ASAEs (non-reportable) |
|---|---|
Metabolic | Perioperative |
 - Hyperglycaemia necessitating treatment or stopping of trial medication  - New onset diabetes necessitating ongoing medical treatment at day 30 of follow-up  - Hyperosmolar hyperglycaemic state |  - Re-bleeding into cavity forming ASDH  - Tension pneumocephalus  - Intracerebral haemorrhage  - Residual CSDH exerting mass effect  - Seizures  - Neurological worsening  - Anaesthetic complications |
Psychiatric | Early |
 - New onset psychosis |  - Residual CSDH  - Expansion of contralateral CSDH  - Seizures |
Gastric | Intermediate and Late |
 - Upper gastrointestinal side (e.g. heartburn, vomiting)  - Peptic ulceration and gastro-intestinal bleeding |  - Recollection of CSDH  - Wound complications  - Surgical site infection and subdural empyema  - Epilepsy |