Table 5.

Adverse drug reaction

	Rovelito® (N=2,770)
System organ class/preferred term	No of subjectsa (%) [case]
Subjects with adverse drug reaction	31 (1.12) [37]
Metabolism and nutrition disorders	1 (0.04) [1]
Hyperkalemia	1 (0.04) [1]
Nervous system disorders	17 (0.61) [19]
Dizziness	9 (0.32) [9]
Headache	9 (0.32) [9]
Dysarthria	1 (0.04) [1]
Cardiac disorders	1 (0.04) [1]
Palpitations	1 (0.04) [1]
Vascular disorders	2 (0.07) [2]
Aneurysm	1 (0.04) [1]
Hypertension	1 (0.04) [1]
Gastrointestinal disorders	5 (0.18) [5]
Gastrointestinal disorder	2 (0.07) [2]
Abdominal pain	1 (0.04) [1]
Dyspepsia	1 (0.04) [1]
Epigastric discomfort	1 (0.04) [1]
Skin and subcutaneous tissue disorders	1 (0.04) [1]
Pruritus	1 (0.04) [1]
Musculoskeletal and connective tissue disorders	1 (0.04) [1]
Myalgia	1 (0.04) [1]
General disorders and administration site conditions	4 (0.14) [4]
Chest discomfort	1 (0.04) [1]
Chest pain	1 (0.04) [1]
Fatigue	1 (0.04) [1]
Edema	1 (0.04) [1]
Investigations	3 (0.11) [3]
Blood creatinine increased	1 (0.04) [1]
Blood pressure increased	1 (0.04) [1]
Blood triglycerides increased	1 (0.04) [1]

Notes: The drug adverse reactions refers to the cases which fall into one of the following: “certainly,” “probable/likely,” “possible,” “unlikely,” “conditional/ unclassified,” “unassessible/unclassifiable,” except for “unlikely” where the correlation with the study medicine can be dismissed. Coded through the system organ class and preferred term of MedDRA (version 19.1).

^aOverlapping participants acceptable.