TABLE 3.
Incidence Rates Per 100 Patient-Years and 95% Confidence Intervals for Adverse Events Listed in Adverse Reactions Section of IFN β-1a SC tiw Prescribing Informationa
| Adverse Event | Study Participants (N = 8,107) IR (95% CI) |
|---|---|
| General disorders and influenza-like symptoms | |
| Influenza-like symptoms | 15.65 (14.96-16.36) |
| Headache | 6.94 (6.52-7.38) |
| Fatigue | 15.02 (14.35-15.72) |
| Pyrexia | 2.65 (2.42-2.89) |
| Rigors | 1.29 (1.13-1.46) |
| Chest pain | 8.48 (8.03-8.95) |
| Malaise | 15.33 (14.65-16.04) |
| Injection-site disorders | |
| Injection-site necrosis | 0.01 (0.00-0.03) |
| Injection-site reaction | 0.03 (0.01-0.07) |
| Central and peripheral nervous system disorder | |
| Hypertonia | 0.23 (0.16-0.30) |
| Coordination abnormal | 2.08 (1.88-2.30) |
| Convulsions | 1.38 (1.22-1.56) |
| Endocrine disorders | |
| Thyroid disorder | 5.08 (4.74-5.44) |
| Gastrointestinal disorders | |
| Abdominal pain | 10.18 (9.67-10.70) |
| Dry mouth | 0.12 (0.08-0.18) |
| Hepatobiliary disorders | |
| Hepatic function abnormal | 0.50 (0.41-0.61) |
| Bilirubinemia | 0.02 (0.01-0.05) |
| Musculoskeletal and connective tissue disorders | |
| Myalgia | 3.11 (2.86-3.38) |
| Back pain | 4.16 (3.87-4.48) |
| Skeletal pain | 0.35 (0.27-0.44) |
| Hematologic disorders | |
| Lymphadenopathy | 1.16 (1.01-1.32) |
| Thrombocytopenia | 0.54 (0.44-0.65) |
| Anemia | 6.25 (5.88-6.65) |
| Psychiatric disorders | |
| Somnolence | 1.11 (0.96-1.27) |
| Skin and subcutaneous tissue disorders | |
| Rash, erythematous | 1.20 (1.05-1.37) |
| Rash, maculo-papular | 0.01 (0.00-0.04) |
| Renal and urinary disorders | |
| Micturition frequency | 3.50 (3.24-3.79) |
| Urinary incontinence | 3.13 (2.87-3.39) |
| Eye disorders | |
| Vision abnormal | 4.04 (3.74-4.36) |
| Xerophthalmia | 0.00 (0.00-0.02) |
a List of adverse reactions does not include those already presented in Table 2 (i.e., psychiatric disorders [depression, suicide], seizures, hepatobiliary disorders, and leukopenia).
CI = confidence interval; IFN β-1a SC tiw = interferon beta-1a administered subcutaneously 3 times weekly; IR = incidence rate.