Table 4. Adverse Events.
| Event | AZA | IFN | p-value1 |
| (Npatients = 69, Nevents = 308, PY = 108) | (Npatients = 77, Nevents = 241, PY = 136) | ||
| All AEs 2 | |||
| Patients – No./PY and rate (95%CI) | 65/108 | 68/136 | p = 0.28 |
| 0.60 (0.47–0.77) | 0.50 (0.40–0.64) | ||
| AEs - No./PY and rate (95%CI) | 308/108 | 241/136 | p<0.01 |
| 2.85 (2.54–3.19) | 1.77 (1.56–2.01) | ||
| Most frequently reported AEs 2 | |||
| Influenza-like illness | |||
| Patients – No./PY and rate (95%CI) | 3/108 | 39/136 | p<0.01 |
| 0.03 (0.01–0.08) | 0.29 (0.20–0.39) | ||
| AEs - No./PY and rate (95%CI) | 3/108 | 41/136 | p<0.01 |
| 0.03 (0.01–0.08) | 0.30 (0.22–0.41) | ||
| Fever | |||
| Patients – No./PY and rate (95%CI) | 2/108 | 19/136 | p<0.01 |
| 0.02 (0.00–0.07) | 0.14 (0.08–0.22) | ||
| AEs - No./PY and rate (95%CI) | 2/108 | 20/136 | p = 0.01 |
| 0.02 (0.00–0.07) | 0.15 (0.09–0.23) | ||
| Local allergic reaction | |||
| Patients – No./PY and rate (95%CI) | 0/108 | 13/136 | - |
| 0.10 (0.05–0.16) | |||
| AEs - No./PY and rate (95%CI) | 0/108 | 14/136 | - |
| 0.10 (0.06–0.17) | |||
| Systemic allergic reaction | |||
| Patients – No./PY and rate (95%CI) | 3/108 | 0/136 | - |
| 0.03 (0.01–0.08) | |||
| AEs - No./PY and rate (95%CI) | 3/108 | 0/136 | - |
| 0.03 (0.01–0.08) | |||
| Nausea/vomiting | |||
| Patients – No./PY and rate (95%CI) | 30/108 | 1/136 | p<0.01 |
| 0.28 (0.19–0.40) | 0.01 (0.00–0.04) | ||
| AEs - No./PY and rate (95%CI) | 35/108 | 1/136 | p<0.01 |
| 0.32 (0.23–0.45) | 0.01 (0.00–0.04) | ||
| Abnormal blood count | |||
| Patients – No./PY and rate (95%CI) | 46/108 | 24/136 | p<0.01 |
| 0.43 (0.31–0.57) | 0.18 (0.11–0.26) | ||
| AEs - No./PY and rate (95%CI) | 106/108 | 39/136 | p<0.01 |
| 0.98 (0.80–1.19) | 0.29 (0.20–0.39) | ||
| Other abnormal blood tests3 | |||
| Patients – No./PY and rate (95%CI) | 24/108 | 37/136 | p = 0.44 |
| 0.22 (0.14–0.33) | 0.27 (0.19–0.37) | ||
| AEs - No./PY and rate (95%CI) | 46/108 | 54/136 | p = 0.72 |
| 0.43 (0.31–0.57) | 0.40 (0.30–0.52) | ||
| Other AE | |||
| Patients – No./PY and rate (95%CI) | 51/108 | 47/136 | p = 0.12 |
| 0.47 (0.35–0.62) | 0.35 (0.25–0.46) | ||
| AEs - No./PY and rate (95%CI) | 70/108 | 54/136 | p<0.01 |
| 0.65 (0.51–0.82) | 0.40 (0.30–0.52) | ||
| Discontinued interventions due to AEs | |||
| No. of patients with discontinued interventions due to AEs (%) | 14 (20.3%) | 6 (7.8%) | p = 0.03 |
| Seriousness of AE 5 | |||
| No. of events (%)4 | |||
| Minor/Moderate | 291 (96.0%) | 236 (98.3%) | p = 0.12 |
| Major/Serious | 12 (4.0%) | 4 (1.7%) | |
| Correlation with study treatment | |||
| No. of events (%)4 | |||
| Non-correlated/Unlikely | 63 (20.7%) | 49 (20.4%) | p = 0.95 |
| Possible/Likely | 242 (79.3%) | 191 (79.6%) |
Abbreviations: AZA, azathioprine; IFN, interferon; PY, person-years.
1
P-values for AZA vs. IFN comparison were obtained through χ2 test with one degree of freedom for rate comparison, discontinued interventions due to adverse events, seriousness of adverse event, and correlation of event with treatment.
2
All 95% CI were estimated using the exact method.
3
Liver enzymes, thyroid function and bilirubin level.
4
The sum does not add up to the total because of some missing values.