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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125903661 | 12590366 | 1 | I | 20160707 | 20160711 | 20160725 | 20160725 | PER | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-45507BP | BOEHRINGER INGELHEIM | 66.62 | YR | F | Y | 77.56000 | KG | 20160726 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125903661 | 12590366 | 1 | PS | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Respiratory (inhalation) | 18 MCG | 507914A,15C3219 | 21395 | 18 | UG | INHALATION POWDER, HARD CAPSULE | QD | |||||
| 125903661 | 12590366 | 2 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 0 | 25 | MG | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125903661 | 12590366 | 1 | Chronic obstructive pulmonary disease |
| 125903661 | 12590366 | 2 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125903661 | 12590366 | Drug ineffective | |
| 125903661 | 12590366 | Incorrect dose administered | |
| 125903661 | 12590366 | Product quality issue |
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 |
|---|---|---|---|---|---|---|
| 125903661 | 12590366 | 1 | 2012 | 0 |