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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125380022 | 12538002 | 2 | F | 20160626 | 20160721 | 20160707 | 20160809 | PER | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-41763BP | BOEHRINGER INGELHEIM | 87.32 | YR | M | Y | 180.53000 | KG | 20160809 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125380022 | 12538002 | 1 | PS | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Respiratory (inhalation) | 18 MCG | Y | 21395 | 18 | UG | INHALATION POWDER, HARD CAPSULE | QD | |||||
| 125380022 | 12538002 | 2 | SS | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Respiratory (inhalation) | 18 MCG | Y | 21395 | 18 | UG | INHALATION POWDER, HARD CAPSULE | QD | |||||
| 125380022 | 12538002 | 3 | SS | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Oral | 18 MCG | Y | 21395 | 18 | UG | INHALATION POWDER, HARD CAPSULE | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125380022 | 12538002 | 1 | Chronic obstructive pulmonary disease |
| 125380022 | 12538002 | 2 | Pneumonia |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125380022 | 12538002 | Dry mouth | |
| 125380022 | 12538002 | Incorrect route of drug administration |
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 |
|---|---|---|---|---|---|---|
| 125380022 | 12538002 | 1 | 201101 | 0 | ||
| 125380022 | 12538002 | 2 | 201601 | 0 | ||
| 125380022 | 12538002 | 3 | 20160626 | 20160626 | 0 |