56 Chapter 3 Tolerability and Adverse Events There were no intraoperative adverse events in any of the four patients. However, 28 SAE’s occurred during this study, with two being probably and nine possibly related to the intervention (table 3). In addition 73 AE’s occurred, with three being probably and 34 possibly related to the intervention (supplement 1). All five probably related events (SAE’s and AE’s) were (hypo)manic symptoms. Possibly related events mostly consisted of self-destructive behavior (41) (autointoxication, auto-mutilation and aggression), other possibly related events were seizures (2), migraine (4) and pain at battery site (1). Severely compromised somatic condition related to severe malnutrition (hypokalemia; hypoglycemia; hypothermia; hyponatremia; low consciousness; edema), characteristic for malnourished AN-patients, presented itself 39 times in this study (table 3 and supplement 1). Table 3. Serious adverse events and their relation to the intervention. Related to DBS Event Times Reported n DBSAN-001 DBSAN-002 DBSAN-003 DBSAN-004 Probable (2) Hypomanic/manic symptoms (admission) 2 1 2 Possible (9) Auto-intoxication 6 3 4 1 1 Seizure 2 1 2 Severe auto mutilation 1 1 1 Unlikely (17) Severely compromised somatic condition related to severe malnutrition (hypokalemia; hypoglycemia; hypothermia; hyponatremia)¹ 11 2 2 7 Low consciousness 2 1 2 Edema 1 1 1 Appendicitis acuta 1 1 1 Conversion 1 1 1 Fracture of cervical vertebrae after collapse 1 1 1 Total number SAE’s 28 8 14 4 0 This number of (S)AE’s reflects the challenging nature of the study, with severely affected patients undergoing a last-resort intervention. The hypomanic symptoms and impulsive character of some (S)AE’s may reflect the adverse effects of DBS. Nevertheless, all patients, the DSMB and the research team deemed it safe to continue the study. DBS did not need to be paused or stopped in any of the patients. Patient reported outcome It proved challenging to adequately measure ‘outcome’ in this chronically ill patient group, with symptoms and consequences of their long history of anorexia nervosa and compromised
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