Table 6.
Adverse events reported during the study.
System Organ Classification/ Preferred Term (PT) |
Reported Incidence by Treatment Group | |
---|---|---|
MTK Film (N = 8) | MTK Tablet (N = 8) | |
Nervous System Disorders | ||
Somnolence | 2 (25.0%)) | 0 (0.0%) |
Headache | 1 (12.5%) | 0 (0.0%) |
Skin and Subcutaneous Tissue Disorders | ||
Pruritus | 1 (12.5%) | 0 (0.0%) |
Mechanical urticaria | 1 (12.5%) | 0 (0.0%) |
Musculoskeletal and Connective Tissue Disorders | ||
Back pain | 1 (12.5%) | 0 (0.0%) |
Total | 6 (75.0%) | 0 (0.0%) |
MTK Film: Montelukast 10 mg Oral Film; Lot No: 16E-MOT010-0001, by IntelGenx Corp. MTK Tablet: Singulair® 10 mg Tablets; Lot No: L044452, by Merck Sharp & Dohme Ltd., Hertfordshire, UK.