TABLE 2

Subjects with AEs of bronchitis, by cohorta

Cohort and site no.Subject gender/age (yr)Bronchitis start/stop (days)GradeAdditional TEAEs (start/stop)Relevant concomitant medicationsPotentially relevant medical historyViral clearance/titersb log10 (genome copies/ml)Influenza subtype
Cohort 1 (750 mg MEDI8852 + OS)
    2001836Female/426/132NoneAzithromycin, brompheniramine + pseudoephedrineRenal cystectomy, cholecystectomyDay 5: <3.097 (LOQ)A/H1N1
    2001836Male/479/182Pharyngitis (day 20/26)Methylprednisolone sodium succinate, brompheniramine + dextromethorphan + pseudoephedrine, salbutamol, sulfamethoxazole + trimethoprimNoneDay 7: NDA/H1N1
    2001836Female/547/152Upper respiratory tract infection (day 7/12); bronchial hyperreactivity (day 9/12)Azithromycin, salbutamol, methylprednisolone sodium succinate, prednisoneTachycardia, depressionDay 7: <3.097 (LOQ); day 9: NDA/H1N1
    2001836Male/585/132Sinusitis (day 9/17)Azithromycin, amoxicillin + clavulanic acidDiabetes mellitus, hypertensionDay 5: 3.16; day 7: 4.40; day 9: 6.61A/H1N1
Cohort 2 (3,000 mg MEDI8852 + OS)
    2001152Male/397/112NoneSalbutamol, beclomethasone dipropionate, amoxicillin + clavulanic acidInfluenza, obesity, bronchospasmDay 5: <3.097 (LOQ); day 7: NDA/H1N1
    2001152Male/433/73NoneTheophylline, salbutamol, fluticasone + salmeterol, amoxicillin + clavulanic acidInfluenza, asthma, hypertensionDay 5: <3.097 (LOQ); day 7: NDA/H1N1
    2001836Female/437/142NoneAzithromycin, methylprednisolone Sodium succinateNoneDay 5: NDA/H1N1
    2001836Male/305/112NoneAzithromycin, methylprednisolone Sodium succinate, salbutamolSeasonal allergiesDay 9: <3.097 (LOQ)A/H1N1
    2001836Female/457/141NoneAzithromycinAsthmaDay 7: NDA/H1N1
Cohort 3 (placebo + OS)
    2001836Male/388/152NoneAzithromycin, brompheniramine + pseudoephedrineHypertriglyceridemia, diabetes mellitusDay 5: NDA/H1N1
Cohort 4 (3,000 mg MEDI8852)
    2001163Female/637/91NonePrednisone, alcophyllex liquidHypertensionDay 5: NDA/H1N1
    2001836Female/2512/202NoneAzithromycin, prednisoneMeningitis, asthmaNo influenza A detected at baselineND
  • a LOQ, limit of quantitation; ND, not detected; OS, oseltamivir; TEAE, treatment-emergent adverse event.

  • b Viral clearance/titers refer to the day by which virus titers were below the limit of quantitation (<3.097 log10) or were not detected during the AE of bronchitis or, if virus was not cleared, provides titer values.