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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
120854833 | 12085483 | 3 | F | 201509 | 20160812 | 20160217 | 20160822 | PER | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-06791BP | BOEHRINGER INGELHEIM | 63.20 | YR | M | Y | 0.00000 | 20160822 | PH | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
120854833 | 12085483 | 1 | PS | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Respiratory (inhalation) | 5 MCG | 503071,15L0212 | 21936 | 2.5 | UG | PRESSURISED INHALATION | BID | |||||
120854833 | 12085483 | 2 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | Oral | 10 MG | 0 | 10 | MG | TABLET | QD | ||||||
120854833 | 12085483 | 3 | C | DULERA | FORMOTEROL FUMARATE DIHYDRATEMOMETASONE FUROATE | 1 | Respiratory (inhalation) | 1 ANZ | 0 | NEBULISER LIQUID | QD |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
120854833 | 12085483 | 1 | Asthma |
120854833 | 12085483 | 2 | Product used for unknown indication |
120854833 | 12085483 | 3 | Product used for unknown indication |
Outcome of event
no results found |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
120854833 | 12085483 | Drug ineffective | |
120854833 | 12085483 | Dyspnoea | |
120854833 | 12085483 | Off label use | |
120854833 | 12085483 | Product quality issue | |
120854833 | 12085483 | Pulmonary function test decreased |
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 |
---|---|---|---|---|---|---|
120854833 | 12085483 | 1 | 201509 | 0 |