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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127387131 | 12738713 | 1 | I | 2015 | 20160902 | 20160913 | 20160913 | PER | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-57803BP | BOEHRINGER INGELHEIM | 0.00 | F | Y | 0.00000 | 20160913 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127387131 | 12738713 | 1 | PS | COMBIVENT | ALBUTEROL SULFATEIPRATROPIUM BROMIDE | 1 | Respiratory (inhalation) | DOSE PER APPLICATION: 20 MCG / 100 MCG; DAILY DOSE: 80 MCG / 400 MCG | 21747 | PRESSURISED INHALATION | QID | ||||||||
| 127387131 | 12738713 | 2 | C | ALBUTEROL INHALER | ALBUTEROL | 1 | Respiratory (inhalation) | FORMULATION: INHALER | 0 | ||||||||||
| 127387131 | 12738713 | 3 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | Respiratory (inhalation) | DOSE PER APPLICATION: 500 MCG/50 MCG; DAILY DOSE: 1000 MCG/ 100 MCG | 0 | BID | |||||||||
| 127387131 | 12738713 | 4 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | Oral | 10 MG | 0 | 10 | MG | TABLET | QD | ||||||
| 127387131 | 12738713 | 5 | C | CETIRIZINE | CETIRIZINE HYDROCHLORIDE | 1 | Oral | 10 MG | 0 | 10 | MG | ORAL SOLUTION | QD | ||||||
| 127387131 | 12738713 | 6 | C | LOSARTAN. | LOSARTAN | 1 | Oral | 100 MG | 0 | 100 | MG | TABLET | QD | ||||||
| 127387131 | 12738713 | 7 | C | ATORVASTATIN | ATORVASTATIN | 1 | Oral | 20 MG | 0 | 20 | MG | TABLET | QD | ||||||
| 127387131 | 12738713 | 8 | C | ESTRADIOL. | ESTRADIOL | 1 | Topical | 0.0071 MG | 0 | .05 | MG | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127387131 | 12738713 | 1 | Chronic obstructive pulmonary disease |
| 127387131 | 12738713 | 2 | Asthma |
| 127387131 | 12738713 | 3 | Asthma |
| 127387131 | 12738713 | 4 | Product used for unknown indication |
| 127387131 | 12738713 | 5 | Asthma |
| 127387131 | 12738713 | 6 | Blood cholesterol increased |
| 127387131 | 12738713 | 7 | Hypertension |
| 127387131 | 12738713 | 8 | Hot flush |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127387131 | 12738713 | Drug ineffective | |
| 127387131 | 12738713 | Total lung capacity abnormal | |
| 127387131 | 12738713 | Unevaluable event |
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 |
|---|---|---|---|---|---|---|
| 127387131 | 12738713 | 1 | 2011 | 0 | ||
| 127387131 | 12738713 | 5 | 2011 | 0 | ||
| 127387131 | 12738713 | 6 | 2011 | 0 | ||
| 127387131 | 12738713 | 7 | 2011 | 0 | ||
| 127387131 | 12738713 | 8 | 1991 | 0 |