Australian public assessment for Ibuprofen - Therapeutic Goods ...

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AusPAR Caldolor Ibuprofen Phebra Pty Ltd PM-2010-02393-3-1 Final 2 January 2013 Therapeutic Goods Administration P-values are for pairwise comparisons with placebo. Results with p
AusPAR Caldolor Ibuprofen Phebra Pty Ltd PM-2010-02393-3-1 Final 2 January 2013 Therapeutic Goods Administration Table 10. CPI-CL-004: Efficacy results according to illness severity stratum. ITT population. (continued) Maximum temperature decrease during 0-4 h (°C) (From ISE) †‡ mean ± SD median treatment - placebo diff. (95% CI for median trt - plac diff.) Maximum temperature decrease during 0-24 h (°C) (From ISE) †‡ mean ± SD median treatment - placebo diff. (95% CI for median trt - plac diff.) AUC-T 0-4 (°F×h) (From ISE) †‡ mean ± SD median treatment - placebo diff. (95% CI for median trt - plac diff.) AUC-T 0-24 (°F×h) (From ISE) †‡ mean ± SD median treatment - placebo diff. (95% CI for median trt - plac diff.) Illness stratum Placebo Caldolor 100 mg Caldolor 200 mg Caldolor 400 mg Critical N=13 N=14 N=12 N=14 Non-critical N=15 N=17 N=18 N=17 Critical 0.4 ± 0.59 Non-critical 1.0 ± 0.80 Critical 1.2 ± 1.07 Non-critical 2.2 ± 0.95 Critical 13.1 ± 2.88 Non-critical 11.7 ± 5.42 Critical 64.7 ± 24.69 Non-critical 46.5 ± 21.14 0.9 ± 0.73 0.5 (0.1, 0.9) 1.7 ± 0.66 0.8 (0.2, 1.2) 1.6 ± 0.94 0.5 (-0.1, 1.0) 2.7 ± 0.86 0.5 (-0.1, 1.1) 9.6 ± 4.01 -3.8 (-6.3, -1.3) 9.1 ± 4.84 -2.6 (-5.9, 0.5) 45.5 ± 26.69 -22.3 (-39.5, -1.9) 30.0 ± 21.50 -18.5 (-33.2, -2.9) P-values are for pairwise comparisons with placebo. Results with p
Page 1 and 2: Australian Public Assessment Report
Page 3 and 4: Contents AusPAR Caldolor Ibuprofen
Page 5 and 6: AusPAR Caldolor Ibuprofen Phebra Pt
Page 11 and 12: Carcinogenicity AusPAR Caldolor Ibu
Page 13 and 14: Nonclinical summary and conclusions
Page 31: Time to afebrility (temp
Page 39 and 40: Table 12. CPI-CL-006: Patient dispo
Page 41 and 42: Other efficacy studies IND 32803 Au
Page 49 and 50: Baseline data AusPAR Caldolor Ibupr
Page 57 and 58: Dose-response and non-pivotal effic
Page 59 and 60: Combined indications AusPAR Caldolo
Page 79 and 80: continued next page AusPAR Caldolor
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AusPAR Caldolor Ibuprofen Phebra Pt
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IVIb = Caldolor. AusPAR Caldolor Ib
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Table 37. IND 32803 (Sepsis syndrom
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Pivotal studies AusPAR Caldolor Ibu
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Pharmacovigilance plan AusPAR Caldo
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Table 44. Other efficacy outcomes.
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Caldolor is indicated for the reduc
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Australian public assessment for Ibuprofen - Therapeutic Goods ...

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