Figure9b The upper bar of each pair represents numbers of reports from – Consumers (blue) and the lower bar reports from Health Care Professionals (red) (Population 2) Figure 10 For a small dataset, a display of PTs may be adequate – SOC Infections and infestations Primary SOC Analysis 25 mg Placebo Adverse Event (MedDRA v18.0) MyDrug (N=15) (N=44) SOC Infections and infestations 14 (31.8%) 4 (26.7%) PT Upper respiratory tract infection 5 2 PT Sinusitis 3 0 PT Urinary tract infection 2 1 PT Ear infection 2 0 PT Viral infection 2 0 PT Bronchitis 1 0 PT Influenza 1 0 PT Localised infection 0 1 PT Lower respiratory tract infection 1 0 PT Pneumonia 1 0 PT Tooth abscess 1 0 Secondary SOC Analysis (same data as above) 25 mg Placebo Adverse Event (MedDRA v18.0) MyDrug (N=15) (N=44) SOC Respiratory, thoracic and mediastinal disorders PT Upper respiratory tract infection 5 2 PT Sinusitis 3 0 PT Bronchitis 1 0 PT Influenza 1 0 PT Lower respiratory tract infection 1 0 PT Pneumonia 1 0
Figure9b – The upper bar of each pair represents numbers of reports from Consumers (blue) and the lower bar reports from Health Care Professionals (red) (Population 2) Figure 10 – For a small dataset, a display of PTs may be adequate SOC Infections and infestations Primary SOC Analysis Adverse Event (MedDRA v18.0) 25 mg MyDrug (N=44) Placebo (N=15) SOC Infections and infestations 14 (31.8%) 4 (26.7%) PT Upper respiratory tract infection 5 2 PT Sinusitis 3 0 PT Urinary tract infection 2 1 PT Ear infection 2 0 PT Viral infection 2 0 PT Bronchitis 1 0 PT Influenza 1 0 PT Localised infection 0 1 PT Lower respiratory tract infection 1 0 PT Pneumonia 1 0 PT Tooth abscess 1 0 Secondary SOC Analysis (same data as above) Adverse Event (MedDRA v18.0) 25 mg MyDrug (N=44) Placebo (N=15) SOC Respiratory, thoracic and mediastinal disorders PT Upper respiratory tract infection 5 2 PT Sinusitis 3 0 PT Bronchitis 1 0 PT Influenza 1 0 PT Lower respiratory tract infection 1 0 PT Pneumonia 1 0
9610-1800_DatRetPTC_R3.9_mar2015.docx