The Safety Rates Drug Report

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Person who experienced the adverse event (patient)

Event ID CASEID CASEVERSION I F COD EVENT DT MFR DT INIT FDA DT FDA DT REPT COD AUTH NUM MFR NUM MFR SNDR LIT REF AGE AGE COD AGE GRP GNDR COD E SUB WT WT COD REPT DT TO MFR OCCP COD REPORTER COUNTRY OCCR COUNTRY
125647092 12564709 2 F 20160704 20160718 20160718 EXP UG-CIPLA LTD.-2016UG09322 CIPLA RHEIN J, MORAWSKI BM, HULLSIEK KH, NABETA HW, KIGGUNDU R, TUGUME L ET AL.,. EFFICACY OF ADJUNCTIVE SERTRALINE FOR THE TREATMENT OF HIV-ASSOCIATED CRYPTOCOCCAL MENINGITIS: AN OPEN-LABEL DOSE-RANGING STUDY. LANCET INFECT DIS. 2016;16:809 TO 818 0.00 Y 0.00000 20160718 OT UG UG

Drug(s) used by person

Event ID CASEID DRUG SEQ ROLE COD DRUGNAME PROD AI VAL VBM ROUTE DOSE VBM CUM DOSE CHR CUM DOSE UNIT DECHAL RECHAL LOT NUM EXP DT NDA NUM DOSE AMT DOSE UNIT DOSE FORM DOSE FREQ
125647092 12564709 1 SS Efavirenz EFAVIRENZ 1 Unknown UNK U U 0
125647092 12564709 2 SS NEVIRAPINE. NEVIRAPINE 1 Unknown UNK U U 0
125647092 12564709 3 PS SERTRALINE SERTRALINE HYDROCHLORIDE 1 Oral 200 MG, DAILY, INDUCTION U U 77397 200 MG
125647092 12564709 4 SS SERTRALINE SERTRALINE HYDROCHLORIDE 1 Oral 200 MG, DAILY, CONSOLIDATION U U 77397 200 MG
125647092 12564709 5 SS AMPHOTERICIN B. AMPHOTERICIN B 1 Unknown 0.7 TO 1.0 MG/KG, QD U U 0
125647092 12564709 6 SS FLUCONAZOLE. FLUCONAZOLE 1 Unknown UNK U U 0
125647092 12564709 7 SS Rifampicin RIFAMPIN 1 Unknown UNK U U 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
125647092 12564709 1 Antiretroviral therapy
125647092 12564709 2 Antiretroviral therapy
125647092 12564709 3 Meningitis cryptococcal
125647092 12564709 5 Meningitis cryptococcal
125647092 12564709 6 Meningitis cryptococcal

Outcome of event

Event ID CASEID OUTC COD
125647092 12564709 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
125647092 12564709 Immune reconstitution inflammatory syndrome

Reporting Sources (this data is often not reported and may therefore be missing here)

no results found

Therapies reported

no results found