Table 2

Number (percentage) of subjects with at least one suspected (or not assessable) adverse event, according to intensity

Initial phase


System organ class/preferred terma

All (n = 43)

Mild

Moderate

Severe

At least one suspected AEb

40 (93.0%)

29 (67.4%)

27 (62.8%)

9 (20.9%)

Rash-All categories

13 (30.2%)

7 (16.3%)

8 (18.6%)

2 (4.7%)

Oedema-All categories

11 (25.6%)

2 (4.7%)

6 (14.0%)

3 (7.0%)

Nausea

10 (23.3%)

6 (14.0%)

5 (11.6%)

Diarrhoea

8 (18.6%)

5 (11.6%)

2 (4.7%)

1 (2.3%)

Headache

6 (14.0%)

4 (9.3%)

2 (4.7%)

Abdominal pain, upper

5 (11.6%)

4 (9.3%)

1 (2.3%)

Vomiting

5 (11.6%)

1 (2.3%)

4 (9.3%)

Asthenia

5 (11.6%)

4 (9.3%)

1 (2.3%)

Pyrexia

3 (7.0%)

1 (2.3%)

1 (2.3%)

1 (2.3%)

Herpes simplex

3 (7.0%)

2 (4.7%)

1 (2.3%)

Weight decreased

3 (7.0%)

2 (4.7%)

1 (2.3%)

Dyspnoea

3 (7.0%)

1 (2.3%)

1 (2.3%)

1 (2.3%)

Abdominal pain

2 (4.7%)

1 (2.3%)

1 (2.3%)

Dry mouth

2 (4.7%)

1 (2.3%)

1 (2.3%)

Hyperthermia

2 (4.7%)

1 (2.3%)

1 (2.3%)

Gastroenteritis

2 (4.7%)

2 (4.7%)

Blood creatinine increased

2 (4.7%)

1 (2.3%)

1 (2.3%)

Cough

2 (4.7%)

1 (2.3%)

1 (2.3%)

Alopecia

2 (4.7%)

2 (4.7%)

Petechiae

2 (4.7%)

1 (2.3%)

1 (2.3%)

Extension phase


System organ class/preferred term

All (n = 21)

Mild

Moderate

Severe

At least one suspected AE

10 (47.6%)

4 (19.0%)

3 (14.3%)

3 (14.3%)

Oedema-All categories

2 (9.5%)

2 (9.5%)

Leukopenia

1 (4.8%)

1 (4.8%)

Vertigo

1 (4.8%)

1 (4.8%)

Aphthous stomatitis

1 (4.8%)

1 (4.8%)

Asthenia

1 (4.8%)

1 (4.8%)

Pyrexia

1 (4.8%)

1 (4.8%)

Liver disorder

1 (4.8%)

1 (4.8%)

Gastroenteritis

1 (4.8%)

1 (4.8%)

Nasopharyngitis

1 (4.8%)

1 (4.8%)

Rhinitis

1 (4.8%)

1 (4.8%)

Neutrophil count decreased

1 (4.8%)

1 (4.8%)

Rheumatoid arthritis

1 (4.8%)

1 (4.8%)

Bronchopneumopathy

1 (4.8%)

1 (4.8%)

Pleural effusion

1 (4.8%)

1 (4.8%)

Eczema

1 (4.8%)

1 (4.8%)

Onychoclasis

1 (4.8%)

1 (4.8%)

Photosensitivity reaction

1 (4.8%)

1 (4.8%)


Table includes those adverse events (AEs) that occurred commonly (that is, in greater than 4% of patients). aMedDRA (medical dictionary for regulatory activities) terminology. bAE intensity count is cumulative. AEs were recorded only once (at their start date).

Tebib et al. Arthritis Research & Therapy 2009 11:R95   doi:10.1186/ar2740

Open Data