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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125379141 | 12537914 | 1 | I | 20160523 | 20160624 | 20160707 | 20160707 | PER | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-41231BP | BOEHRINGER INGELHEIM | 84.19 | YR | M | Y | 0.00000 | 20160707 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125379141 | 12537914 | 1 | PS | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Respiratory (inhalation) | 2.5 MCG | 21936 | 2.5 | UG | PRESSURISED INHALATION | QD | ||||||
| 125379141 | 12537914 | 2 | C | NAPROSYN | NAPROXEN | 1 | Oral | 0 | TABLET | ||||||||||
| 125379141 | 12537914 | 3 | C | ASPIRIN. | ASPIRIN | 1 | Oral | 325 MG | 0 | 325 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125379141 | 12537914 | 1 | Pulmonary fibrosis |
| 125379141 | 12537914 | 2 | Arthritis |
| 125379141 | 12537914 | 3 | Cardiac disorder |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125379141 | 12537914 | Hyperaesthesia | |
| 125379141 | 12537914 | 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 |
|---|---|---|---|---|---|---|
| 125379141 | 12537914 | 1 | 20160523 | 0 |