TABLE 3.

Serious adverse events

Author, Year	Serious adverse events
	Lifestyle/Reduced calorie diet arm (n)	Control (n)	p‐Value
Lean et al.27	n = 7 Two events in the same patient thought to be related to intervention—biliary colic and abdominal pain. Others were brief overnight admissions for unrelated investigations/events. None led to withdrawal from the trial.	n = 2 Including categories of infection and infestation, wound infection, nervous system disorders, seventh nerve paralysis.	Non‐significant (described in Lean et al., 2019)
Lean et al.28Year 2 results	n = 9 events in 6 participants One non‐fatal MI in a patient that did not attend for review. None led to withdrawal from the trial.	n = 22 events in 16 participants x2 cerbrovascular accident, toe amputation, aortic aneurysm rupture, sudden death.	0.029
Bhatt et al.24	Not described.
Sarathi et al.29	Not described.
Gregg et al.30	Not described for subpopulation examined in this analysis.
Ried‐Larsen et al.32 Johansen et al.33	n = 1 Atrial fibrillation.	n = 0	1.00
Ades et al.34	Not described
Umphonsathien et al.35	n = 0
Taheri et al.36	n = 0	n = 55 events in 4 participants 4 admissions to hospitals for unexpected event—supraventricular tachycardia, abdominal pain, pneumonia and epididymo‐orchitis. 1 expected event—hyperglycemia	Not reported