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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126071602 | 12607160 | 2 | F | 2016 | 20160727 | 20160729 | 20160803 | EXP | US-SUNOVION-2016SUN001827 | SUNOVION | 89.00 | YR | F | Y | 37.64000 | KG | 20160803 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126071602 | 12607160 | 1 | PS | BROVANA | ARFORMOTEROL TARTRATE | 1 | Respiratory (inhalation) | 15MCG/2ML, BID | S15K011 | 21912 | 15 | UG | NEBULISER SOLUTION | BID | |||||
| 126071602 | 12607160 | 2 | SS | BROVANA | ARFORMOTEROL TARTRATE | 1 | 21912 | NEBULISER SOLUTION | |||||||||||
| 126071602 | 12607160 | 3 | SS | BROVANA | ARFORMOTEROL TARTRATE | 1 | 21912 | NEBULISER SOLUTION | |||||||||||
| 126071602 | 12607160 | 4 | SS | BUDESONIDE. | BUDESONIDE | 1 | UNK | Y | 0 | ||||||||||
| 126071602 | 12607160 | 5 | SS | PREDNISONE. | PREDNISONE | 1 | UNK | U | 0 | ||||||||||
| 126071602 | 12607160 | 6 | SS | LEVAQUIN | LEVOFLOXACIN | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126071602 | 12607160 | 1 | Bronchiectasis |
| 126071602 | 12607160 | 2 | Asthma |
| 126071602 | 12607160 | 3 | Cough |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126071602 | 12607160 | OT |
| 126071602 | 12607160 | HO |
| 126071602 | 12607160 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126071602 | 12607160 | Candida infection | |
| 126071602 | 12607160 | Cough | |
| 126071602 | 12607160 | Epistaxis | |
| 126071602 | 12607160 | Fall | |
| 126071602 | 12607160 | Off label use | |
| 126071602 | 12607160 | Pelvic fracture | |
| 126071602 | 12607160 | Thyroid disorder | |
| 126071602 | 12607160 | Unresponsive to stimuli |
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 |
|---|---|---|---|---|---|---|
| 126071602 | 12607160 | 1 | 2016 | 2016 | 0 |