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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125418611 | 12541861 | 1 | I | 2011 | 20160627 | 20160708 | 20160708 | PER | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-41666BP | BOEHRINGER INGELHEIM | 0.00 | F | Y | 0.00000 | 20160708 | CN | US | US |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125418611 | 12541861 | 1 | PS | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Respiratory (inhalation) | 18 MCG | 505463A | 21395 | 18 | UG | INHALATION POWDER, HARD CAPSULE | QD | |||||
125418611 | 12541861 | 2 | SS | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Oral | 18 MCG | 505463A | 21395 | 18 | UG | INHALATION POWDER, HARD CAPSULE | QD |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
125418611 | 12541861 | 1 | Asthma |
Outcome of event
no results found |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
125418611 | 12541861 | Incorrect route of drug administration | |
125418611 | 12541861 | Off label use |
Reporting Sources (this data is often not reported and may therefore be missing here)
no results found |
Therapies reported
Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
---|---|---|---|---|---|---|
125418611 | 12541861 | 1 | 2011 | 0 | ||
125418611 | 12541861 | 2 | 20160627 | 20160627 | 0 |