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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124571602 | 12457160 | 2 | F | 201604 | 20160706 | 20160610 | 20160712 | EXP | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-36851BP | BOEHRINGER INGELHEIM | 82.52 | YR | F | Y | 47.17000 | KG | 20160712 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124571602 | 12457160 | 1 | PS | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Respiratory (inhalation) | 18 MCG | Y | 21395 | 18 | UG | INHALATION POWDER, HARD CAPSULE | QD | |||||
| 124571602 | 12457160 | 2 | SS | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Respiratory (inhalation) | 18 MCG | Y | 21395 | 18 | UG | INHALATION POWDER, HARD CAPSULE | QD | |||||
| 124571602 | 12457160 | 3 | SS | XOPENEX | LEVALBUTEROL HYDROCHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 124571602 | 12457160 | 4 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124571602 | 12457160 | 1 | Chronic obstructive pulmonary disease |
| 124571602 | 12457160 | 3 | Product used for unknown indication |
| 124571602 | 12457160 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124571602 | 12457160 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124571602 | 12457160 | Atrial fibrillation | |
| 124571602 | 12457160 | Cardiac failure congestive |
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 |
|---|---|---|---|---|---|---|
| 124571602 | 12457160 | 1 | 2011 | 0 |