Table 5.

Treatment-emergent adverse events in ≥ 1% of patients (N = 151)

MedDRA preferred term	Frequency	Serious	Possibly related to treatment	Discontinued treatmenta	Resolvedb
Renal failurec	12 (7.9)	7 (4.6)	11 (7.3)	7 (4.6)	6 (4.0)
Cardiac arrest	3 (2.0)	3 (2.0)	1 (0.7)	3 (2.0)	0
Respiratory failure	3 (2.0)	3 (2.0)	0	3 (2.0)	0
Sepsis	3 (2.0)	3 (2.0)	1 (0.7)	3 (2.0)	0

Data presented as n (%)

MedDRA medical dictionary of regulatory activities, TEAE treatment-emergent adverse event

^aDiscontinued treatment includes those patients who had drug withdrawn or withdrew from the study

^bResolved includes those events that were Recovered/Resolved, Recovered/Resolved with Sequelae, or Recovering/Resolving

^cIncludes TEAEs reported as MedDRA terms “renal failure” or “renal failure acute”