Table 4 Summary of adverse events during the study period according to treatment groups (Safety set)

Overall AE, n (%) [no. of cases]

13 (6.37) [15]

7 (6.86) [7]

6 (5.88) [8]

0.774^a)

ADR

5 (2.45) [5]

3 (2.94) [3]

2 (1.96) [2]

1.000^b)

SAE

–

–

–

Infections and infestations

3 (1.47) [3]

1 (0.98) [1]

2 (1.96) [2]

1.000^b)

Herpes zoster

1 (0.49) [1]

1 (0.98%) [1]

–

1.000^b)

Nasopharyngitis

1 (0.49) [1]

–

1 (0.98) [1]

1.000^b)

Otitis media chronic

1 (0.49) [1]

–

1 (0.98) [1]

1.000^b)

Skin and subcutaneous tissue disorders

3 (1.47) [3]

2 (1.96) [2]

1 (0.98) [1]

1.000^b)

Photosensitivity reaction

1 (0.49) [1]

1 (0.98) [1]

–

1.000^b)

Pruritus generalised

1 (0.49) [1]

–

1 (0.98) [1]

1.000^b)

Urticaria

1 (0.49) [1]

1 (0.98) [1]

–

1.000^b)

Investigations

2 (0.98) [2]

1 (0.98) [1]

1 (0.98) [1]

1.000^b)

Blood glucose increased

1 (0.49) [1]

–

1 (0.98) [1]

1.000^b)

Low density lipoprotein increased

1 (0.49) [1]

1 (0.98) [1]

–

1.000^b)

Nervous system disorders

2 (0.98) [2]

–

2 (1.96) [2]

0.498^b)

Headache

1 (0.49) [1]

–

1 (0.98) [1]

1.000^b)

Migraine without aura

1 (0.49) [1]

–

1 (0.98) [1]

1.000^b)

Cardiac disorders

1 (0.49) [1]

–

1 (0.98) [1]

1.000^b)

Palpitations

1 (0.49) [1]

–

1 (0.98) [1]

1.000^b)

Eye disorders

1 (0.49) [1]

–

1 (0.98) [1]

1.000^b)

Dry eye

1 (0.49) [1]

–

1 (0.98) [1]

1.000^b)

General disorders and administration site conditions

1 (0.49) [1]

1 (0.98) [1]

–

1.000^b)

Oedema peripheral

1 (0.49) [1]

1 (0.98) [1]

–

1.000^b)

Psychiatric disorders

1 (0.49) [1]

1 (0.98) [1]

–

1.000^b)

Insomnia

1 (0.49) [1]

1 (0.98) [1]

–

1.000^b)

Vascular disorders

1 (0.49) [1]

1 (0.98) [1]

–

1.000^b)

Hypotension

1 (0.49) [1]

1 (0.98) [1]

–

1.000^b)