Table 3.
Summary of treatment-emergent adverse events
| Parameter | CZP+MTX n=159 PY=136.2 n (%) |
PBO+MTX n=157 PY=116.0 n (%) |
|---|---|---|
| AE summary | ||
| Any AEs | 153 (96.2) 542.0* |
148 (94.3) 548.2* |
| Serious AEs | 13 (8.2) 11.0* |
14 (8.9) 12.9* |
| Deaths | 0 | 0 |
| AEs of interest | ||
| Infections and infestations | 97 (61.0) | 87 (55.4) |
| Serious infection | 5 (3.1) | 7 (4.5) |
| Pneumocystis jiroveci pneumonia | 3 (1.9) | 2 (1.3) |
| Bronchitis | 1 (0.6) | 0 |
| Meningitis fungal | 1 (0.6) | 0 |
| Pneumonia bacterial | 1 (0.6) | 2 (1.3) |
| Pneumonia | 0 | 1 (0.6) |
| Pneumonia mycoplasmal | 0 | 1 (0.6) |
| Pyelonephritis acute | 0 | 1 (0.6) |
| Pneumonia | 7 (4.4) | 8 (5.1) |
| Pneumonia bacterial | 4 (2.5) | 2 (1.3) |
| Pneumocystis jiroveci pneumonia | 3 (1.9) | 3 (1.9) |
| Bronchopneumonia | 1 (0.6) | 0 |
| Pneumonia | 0 | 2 (1.3) |
| Pneumonia mycoplasmal | 0 | 1 (0.6) |
| Tuberculosis | 0 | 0 |
| Interstitial lung disease | 5 (3.1) | 1 (0.6) |
| Malignancies† | 1 (0.6) | 0 |
| Hepatic disorders‡ | 68 (42.8) | 70 (44.6) |
| Hematopoietic cytopenias§ | 12 (7.5) | 13 (8.3) |
| Nausea/vomiting/decreased appetite | 39 (24.5) | 32 (20.4) |
| Stomatitis | 19 (11.9) | 26 (16.6) |
| Injection site reaction | 5 (3.1) | 2 (1.3) |
*Event rate: per 100 patients-years.
†Cervix carcinoma.
‡Including following preferred terms: alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyltransferase increased, hepatic function abnormal, hepatic enzyme increased, hepatic steatosis, hyperbilirubinaemia, liver disorder, liver function test abnormal.
§Including following preferred terms: granulocytopenia, leucopenia, lymphopenia, lymphocyte count decreased, white blood cell count decreased.
AE, adverse event; CZP, certolizumab pegol; MTX, methotrexate; PBO, placebo; PY, total summation of individual patient-years.