Table 5 Adverse events during the study in the safety population. Given are numbers of subjects with events and number of events (absolute/% of total)

Subjects eligible for AES (after drugging)

7

13

4

5

Subjects with AEs or Numbers of events

7

11

12

29

4

10

5

17

Any AE

6 (75%)

11 (100%)

10 (83%)

29 (100%)

3 (75%)

10 (100%)

5 (100%)

17 (100%)

Any related AEs

1 (13%)

3 (27%)

1 (8%)

2 (7%)

–

–

–

–

Any serious AEs/deaths

–

–

1 (8%)

1 (3%)

–

–

–

–

Any AEs leading to premature study discontinuation

–

–

1 (8%)

1 (3%)

–

–

–

–

Details on AEs*

Infections (sinusitis, otitis, upper/lower respiratory tract infection)

3 (43%)

4 (36%)

9 (75%)

15 (52%)

2 (50%)

6 (60%)

4 (80%)

13 (76%)

Blood (White blood cell disorder)

–

–

1 (8%)

1 (4%)

–

–

–

–

Psychiatric disorders (restlessness)

–

–

1 (8%)

1 (4%)

–

–

–

–

Nervous system disorders

–

–

1 (8%)

1 (4%)

–

–

–

–

Eye disorders (Cataract)

–

–

1 (8%)

1 (4%)

–

–

–

–

Respiratory disorders (cough, pain)

1 (14%)

2 (18%)

2 (17%)

3 (10%)

2 (50%)

2 (20%)

1 (20%)

1 (6%)

Gastrointestinal disorders (constipation, stomatitis)

2 (29%)

4 (36%)

2 (17%)

3 (10%)

2 (50%)

2 (20%)

1 (20%)

1 (6%)

Musculoskeletal and connective tissue disorders (Arthralgia)

–

–

1 (8%)

2 (7%)

–

–

1 (20%)

1 (6%)

General disorders (exercise tolerance decreased, hyperthermia malignant, pyrexia)

1 (14%)

1 (9%)

1 (8%)

1 (4%)

–

–

1 (20%)

1 (6%)