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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123489033 | 12348903 | 3 | F | 201509 | 20160705 | 20160509 | 20160711 | EXP | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-26277BP | BOEHRINGER INGELHEIM | 76.94 | YR | F | Y | 0.00000 | 20160711 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123489033 | 12348903 | 1 | PS | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Respiratory (inhalation) | 18 MCG | 501305A | 21395 | 18 | UG | INHALATION POWDER, HARD CAPSULE | QD | |||||
| 123489033 | 12348903 | 2 | SS | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Respiratory (inhalation) | 18 MCG | 501305A | 21395 | 18 | UG | INHALATION POWDER, HARD CAPSULE | QD | |||||
| 123489033 | 12348903 | 3 | SS | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Respiratory (inhalation) | 1 PUF | 501305A | 21395 | INHALATION POWDER, HARD CAPSULE | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123489033 | 12348903 | 1 | Chronic obstructive pulmonary disease |
| 123489033 | 12348903 | 2 | Bronchiectasis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123489033 | 12348903 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123489033 | 12348903 | Adverse drug reaction | |
| 123489033 | 12348903 | Asthenia | |
| 123489033 | 12348903 | Bronchiectasis | |
| 123489033 | 12348903 | Bronchitis | |
| 123489033 | 12348903 | Diabetes mellitus | |
| 123489033 | 12348903 | Dizziness | |
| 123489033 | 12348903 | Dyspnoea | |
| 123489033 | 12348903 | Haemoptysis | |
| 123489033 | 12348903 | Osteoporosis | |
| 123489033 | 12348903 | Productive cough | |
| 123489033 | 12348903 | Thrombosis |
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 |
|---|---|---|---|---|---|---|
| 123489033 | 12348903 | 1 | 2000 | 0 | ||
| 123489033 | 12348903 | 2 | 2010 | 0 | ||
| 123489033 | 12348903 | 3 | 20150514 | 0 |