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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126195742 | 12619574 | 2 | F | 2013 | 20160829 | 20160803 | 20160831 | EXP | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-49711BP | BOEHRINGER INGELHEIM | 82.18 | YR | F | Y | 0.00000 | 20160831 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126195742 | 12619574 | 1 | PS | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Respiratory (inhalation) | 18 MCG | 508420A,15C3226 | 21395 | 18 | UG | INHALATION POWDER, HARD CAPSULE | QD | |||||
| 126195742 | 12619574 | 2 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 | |||||||||||
| 126195742 | 12619574 | 3 | C | DIAZEPAM. | DIAZEPAM | 1 | Unknown | 0 | |||||||||||
| 126195742 | 12619574 | 4 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | Unknown | DISKUS | 0 | ||||||||||
| 126195742 | 12619574 | 5 | C | Hydrocodone | HYDROCODONE | 1 | Unknown | 0 | |||||||||||
| 126195742 | 12619574 | 6 | C | GABAPENTIN. | GABAPENTIN | 1 | Unknown | 0 | |||||||||||
| 126195742 | 12619574 | 7 | C | FENOFIBRATE. | FENOFIBRATE | 1 | Unknown | 0 | |||||||||||
| 126195742 | 12619574 | 8 | C | ALLOPURINOL. | ALLOPURINOL | 1 | Unknown | 0 | |||||||||||
| 126195742 | 12619574 | 9 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | Unknown | 0 | |||||||||||
| 126195742 | 12619574 | 10 | C | TIZANIDINE. | TIZANIDINE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126195742 | 12619574 | 1 | Chronic obstructive pulmonary disease |
| 126195742 | 12619574 | 2 | Product used for unknown indication |
| 126195742 | 12619574 | 3 | Product used for unknown indication |
| 126195742 | 12619574 | 4 | Product used for unknown indication |
| 126195742 | 12619574 | 5 | Product used for unknown indication |
| 126195742 | 12619574 | 6 | Product used for unknown indication |
| 126195742 | 12619574 | 7 | Product used for unknown indication |
| 126195742 | 12619574 | 8 | Gout |
| 126195742 | 12619574 | 9 | Product used for unknown indication |
| 126195742 | 12619574 | 10 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126195742 | 12619574 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126195742 | 12619574 | Lung neoplasm malignant | |
| 126195742 | 12619574 | Product quality issue | |
| 126195742 | 12619574 | Pulmonary mass |
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 |
|---|---|---|---|---|---|---|
| 126195742 | 12619574 | 1 | 2013 | 0 |