Table 2.

Adverse events and drug-related adverse events during the multiple-dose period (a) and extension period (b)

(a)
[System Organ Class] Preferred term	Adverse events				Drug-related adverse events
	1 mg N = 27		4 mg N = 24		1 mg N = 27		4 mg N = 24
	n	(%)	n	(%)	n	(%)	n	(%)
Patients with any events	8	29.6	15	62.5	0		9	37.5
[Cardiac disorders]	0		1	4.2	0		0
Supraventricular tachycardia	0		1	4.2	0		0
[Eye disorders]	0		2	8.3	0		0
Retinal hemorrhage	0		1	4.2	0		0
Vitreous detachment	0		1	4.2	0		0
[Gastrointestinal disorders]	2	7.4	1	4.2	0		0
Diarrhea	1	3.7	0		0		0
Enterocolitis	1	3.7	0		0		0
Nausea	0		1	4.2	0		0
[Infections and infestations]	3	11.1	3	12.5	0		0
Nasopharyngitis	2	7.4	3	12.5	0		0
Pneumonia	1	3.7	0		0		0
[Injury, poisoning and procedural complications]	0		2	8.3	0		0
Excoriation	0		1	4.2	0		0
Wound	0		1	4.2	0		0
[Investigations]	2	7.4	8	33.3	0		8	33.3
Blood calcium decreased	0		8	33.3	0		8	33.3
Hemoglobin decreased	1	3.7	0		0		0
Liver function test abnormal	1	3.7	0		0		0
[Musculoskeletal and connective tissue disorders]	2	7.4	0		0		0
Musculoskeletal pain	1	3.7	0		0		0
Pain in extremity	1	3.7	0		0		0
[Nervous system disorders]	0		1	4.2	0		1	4.2
Hypoesthesia	0		1	4.2	0		1	4.2
[Respiratory, thoracic, and mediastinal disorders]	1	3.7	0		0		0
Oropharyngeal pain	1	3.7	0		0		0
[Skin and subcutaneous tissue disorders]	0		1	4.2	0		0
Hemorrhage subcutaneous	0		1	4.2	0		0

(b)
[System Organ Class] Preferred term	Adverse events				Drug-related adverse events
	8 mg N = 5		12 mg N = 4		8 mg N = 5		12 mg N = 4
	n	(%)	n	(%)	n	(%)	n	(%)
Patients with any events	0		1	25.0	0		0
[Infections and infestations]	0		1	25.0	0		0
Nasopharyngitis	0		1	25.0	0		0
[Musculoskeletal and connective tissue disorders]	0		1	25.0	0		0
Musculoskeletal pain	0		1	25.0	0		0