Table 3. Overview of adverse events.

Patient number	Treatment group	MedDRA PPT	MedDRA SOC	Serious	Intensity/grade
5	4	Leukopenia	Blood and lymphatic system disorders	no	mild/1
5	4	Partial seizures	Nervous system disorders	no	mild/1
5	4	Hyponatraemia	Metabolism and nutrition disorders	no	mild/1
9	1	Renal failure	Renal and urinary disorders	no	moderate/2
9	1	Atrial fibrillation	Cardiac disorders	no	moderate/2
11	3	Post procedural haemorrhage	Injury, poisoning and procedural complications	no	mild/1
11	3	Post procedural haemorrhage	Injury, poisoning and procedural complications	no	mild/1
11	3	General physical health deterioration	General disorders and administration site conditions	no	mild/1
2	2	Stomatitis	Gastrointestinal disorders	no	mild/1
2	2	Radiation skin injury	Injury, poisoning and procedural complications	no	mild/1
2	2	Metastasis	Neoplasms benigns, malignant and unspecified (incl. cysts and polyps)	yes	severe/3
10	4	Pneumonia	Infections and infestations	no	moderate/2
10	4	Anaemia	Blood and lymphatic system disorders	no	mild/1
7	3	Radiation skin injury	Injury, poisoning and procedural complications	no	mild/1
8	4	Leukopenia	Blood and lymphatic system disorders	no	mild/1
8	4	Hypokalaemia	Metabolisms and nutrition disorders	no	mild/1
4	1	Dehydration	Metabolism and nutrition disorders	no	mild/1
4	1	Leukopenia	Blood and lymphatic system disorders	no	mild/1
1	2	Leukopenia	Blood and lymphatic system disorders	no	mild/1
1	2	Seizure	Nervous system disorders	no	mild/1
1	2	Dehydration	Metabolism and nutrition disorders	no	mild/1
1	2	Cerebral ischaemia	Nervous system disorders	yes	moderate/2
1	2	Dehydration	Metabolism and nutrition disorders	yes	mild/1
1	2	Apathy	Psychiatric disorders	yes	moderate/2
12	1	General physical health deterioration	General disorders and administration site conditions	no	mild/1