reporttype1receiptdateformat102companynumbUS-DRREDDYS-USA/USA/14/0037307occurcountryUSVersion of Safety Report ID1receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10089617Date Received21/04/2014transmissiondate12/12/2014serious2Date Last Updated21/04/2014primarysourcecountryUS
Receiver
receivertype6receiverorganizationFDA
Primary Source
reportercountryUSqualification1
Sender
sendertype2senderorganizationFDA-Public Use
Patient
Onset Age18Unit of Onset AgeyearsSexMale
Reaction
1)
reactionmeddraversionpt17.0ReactionLiver function test abnormalOutcomeUnknown
Drug
1)
drugcharacterization1medicinalproductZENATANEdrugbatchnumbUNKNOWNdrugauthorizationnumb202099drugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate07/10/2013actiondrug5drugrecurreadministration3