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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126454471 | 12645447 | 1 | I | 201601 | 20160726 | 20160811 | 20160811 | PER | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-49137BP | BOEHRINGER INGELHEIM | 81.92 | YR | F | Y | 0.00000 | 20160811 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126454471 | 12645447 | 1 | PS | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Respiratory (inhalation) | 2 ANZ | 21936 | PRESSURISED INHALATION | QD | ||||||||
| 126454471 | 12645447 | 2 | C | LOSARTAN. | LOSARTAN | 1 | Oral | 2 ANZ | 0 | TABLET | BID | ||||||||
| 126454471 | 12645447 | 3 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Oral | 1 ANZ | 0 | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126454471 | 12645447 | 1 | Chronic obstructive pulmonary disease |
| 126454471 | 12645447 | 2 | Hypertension |
| 126454471 | 12645447 | 3 | Hypertension |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126454471 | 12645447 | Dysphonia | |
| 126454471 | 12645447 | Nasopharyngitis | |
| 126454471 | 12645447 | Vocal cord paralysis |
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 |
|---|---|---|---|---|---|---|
| 126454471 | 12645447 | 1 | 2015 | 0 | ||
| 126454471 | 12645447 | 2 | 2014 | 0 | ||
| 126454471 | 12645447 | 3 | 2008 | 0 |