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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124895573 | 12489557 | 3 | F | 2014 | 20160825 | 20160622 | 20160901 | PER | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-37434BP | BOEHRINGER INGELHEIM | 0.00 | M | Y | 0.00000 | 20160901 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124895573 | 12489557 | 1 | PS | COMBIVENT | ALBUTEROL SULFATEIPRATROPIUM BROMIDE | 1 | Respiratory (inhalation) | DOSE PER APPLICATION 20 MG/100 MCG; DAILY DOSE: 80MG/400 MCG, SPRAY | 504737A,502317C,502762A | 21747 | PRESSURISED INHALATION | QID | |||||||
| 124895573 | 12489557 | 2 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 10 MG | 0 | 10 | MG | TABLET | QD | ||||||
| 124895573 | 12489557 | 3 | C | MONTELUKAST | MONTELUKAST SODIUM | 1 | Oral | 1 ANZ | 0 | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124895573 | 12489557 | 1 | Asthma |
| 124895573 | 12489557 | 2 | Asthma |
| 124895573 | 12489557 | 3 | Asthma |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124895573 | 12489557 | Dyspnoea | |
| 124895573 | 12489557 | Off label use | |
| 124895573 | 12489557 | Product quality issue |
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 |
|---|---|---|---|---|---|---|
| 124895573 | 12489557 | 1 | 2014 | 0 |