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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125847901 | 12584790 | 1 | I | 201605 | 20160705 | 20160722 | 20160722 | PER | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-44054BP | BOEHRINGER INGELHEIM | 59.23 | YR | M | Y | 0.00000 | 20160723 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125847901 | 12584790 | 1 | PS | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Respiratory (inhalation) | 5 MCG | Y | 5021790 | 21936 | 2.5 | UG | PRESSURISED INHALATION | BID | ||||
| 125847901 | 12584790 | 2 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 0 | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125847901 | 12584790 | 1 | Chronic obstructive pulmonary disease |
| 125847901 | 12584790 | 2 | Chronic obstructive pulmonary disease |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125847901 | 12584790 | Dysphonia | |
| 125847901 | 12584790 | Irritability |
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 |
|---|---|---|---|---|---|---|
| 125847901 | 12584790 | 1 | 201605 | 20160628 | 0 | |
| 125847901 | 12584790 | 2 | 2010 | 0 |