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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125452563 | 12545256 | 3 | F | 201501 | 20160830 | 20160711 | 20160902 | EXP | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-45108BP | BOEHRINGER INGELHEIM | 70.60 | YR | F | Y | 0.00000 | 20160902 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125452563 | 12545256 | 1 | PS | COMBIVENT | ALBUTEROL SULFATEIPRATROPIUM BROMIDE | 1 | Respiratory (inhalation) | 10 ANZ | U | 21747 | PRESSURISED INHALATION | ||||||||
| 125452563 | 12545256 | 2 | C | ALBUTEROL. | ALBUTEROL | 1 | Respiratory (inhalation) | 0 | NEBULISER LIQUID | ||||||||||
| 125452563 | 12545256 | 3 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | Respiratory (inhalation) | 0 | ORAL SOLUTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125452563 | 12545256 | 1 | Chronic obstructive pulmonary disease |
| 125452563 | 12545256 | 2 | Chronic obstructive pulmonary disease |
| 125452563 | 12545256 | 3 | Chronic obstructive pulmonary disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125452563 | 12545256 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125452563 | 12545256 | Cardiac failure congestive | |
| 125452563 | 12545256 | Fluid retention | |
| 125452563 | 12545256 | Full blood count decreased | |
| 125452563 | 12545256 | Incorrect dosage administered | |
| 125452563 | 12545256 | White blood cell count increased |
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 |
|---|---|---|---|---|---|---|
| 125452563 | 12545256 | 1 | 201501 | 0 |