Table 2: Summary of treatment-emergent adverse events in patients exposed to etanercept in the study.

Adverse Event No. of Events (Events per PY)
Totala
(N=365)
Cumulative Etanercept Exposure=798.11 PY
Total adverse events 1,354 (1.70)
Infections and infestations 471 (0.59)
Neoplasmsb 17 (0.02)
Most frequent adverse eventsc
     Bronchitis
     Influenza
     Nasopharyngitis
     Urinary tract infection
     Pharyngitis
     Nausea
     Headache
     Hypertension
     Sinusitis
     Back pain
     Cough		  
58 (0.07)
50 (0.06)
56 (0.07)
45 (0.06)
38 (0.05)
29 (0.04)
27 (0.03)
28 (0.04)
19 (0.02)
21 (0.03)
19 (0.02)
Total serious adverse events 57 (0.07)
Serious infections and infestations
     Appendicitis
     Bronchopneumonia
     Dengue fever
     Latent tuberculosis
     Perirectal abscess
     Pneumonia
     Postoperative abscess
     Postoperative wound infection
     Septic shock
     Urinary tract infection		 15 (0.02)
2 (0.003)
1 (0.001)
2 (0.003)
1 (0.001)
1 (0.001)
2 (0.003)
1 (0.001)
1 (0.001)
1 (0.001)
3 (0.004)
Serious neoplasmsb
     Basal cell carcinoma
     Breast cancer
     Cervix carcinoma
     Malignant lung neoplasm
     Ovarian tumor
     Prostate cancer		 6 (0.01)
1 (0.001)
1 (0.001)
1 (0.001)
1 (0.001)
1 (0.001)
1 (0.001)

DMARD indicates disease-modifying anti-rheumatic drug; PY, patient-year.
a Events were calculated for all patients exposed to etanercept from the start of the randomized phase in the etanercept-plus-methotrexate group and from the start of the extension in the DMARD-plus-methotrexate group.
b Benign, malignant, and unspecified.
c Excluding injection site reactions.