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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126490872 | 12649087 | 2 | F | 2016 | 20160926 | 20160812 | 20160928 | EXP | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-51880BP | BOEHRINGER INGELHEIM | 0.00 | F | Y | 100.69000 | KG | 20160928 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126490872 | 12649087 | 1 | PS | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Respiratory (inhalation) | 10 MCG | Y | 21936 | 5 | UG | PRESSURISED INHALATION | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126490872 | 12649087 | 1 | Chronic obstructive pulmonary disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126490872 | 12649087 | OT |
| 126490872 | 12649087 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126490872 | 12649087 | Gastrointestinal haemorrhage | |
| 126490872 | 12649087 | Incorrect dose administered | |
| 126490872 | 12649087 | Rectal haemorrhage |
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 |
|---|---|---|---|---|---|---|
| 126490872 | 12649087 | 1 | 2016 | 0 |