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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125534491 | 12553449 | 1 | I | 201505 | 20151111 | 20160713 | 20160713 | PER | US-PERRIGO-15US011934 | PERRIGO | 63.98 | YR | M | Y | 90.70000 | KG | 20160713 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125534491 | 12553449 | 1 | PS | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | Oral | 15 MG, QD | U | UNKNOWN | 202319 | 15 | MG | MODIFIED-RELEASE CAPSULE, HARD | |||||
| 125534491 | 12553449 | 2 | SS | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | Oral | 15 MG, QD | U | 5DE1216 | 202319 | 15 | MG | MODIFIED-RELEASE CAPSULE, HARD | |||||
| 125534491 | 12553449 | 3 | SS | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | Oral | 15 MG, QD | U | 5AE2005 | 202319 | 15 | MG | MODIFIED-RELEASE CAPSULE, HARD | |||||
| 125534491 | 12553449 | 4 | C | ASPIRIN. | ASPIRIN | 1 | Unknown | 81 MG | U | P83356 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125534491 | 12553449 | 1 | Barrett's oesophagus |
| 125534491 | 12553449 | 4 | Cardiovascular event prophylaxis |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125534491 | 12553449 | Drug ineffective for unapproved indication | |
| 125534491 | 12553449 | Incorrect drug administration duration |
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 |
|---|---|---|---|---|---|---|
| 125534491 | 12553449 | 1 | 201510 | 0 | ||
| 125534491 | 12553449 | 2 | 201510 | 201511 | 0 | |
| 125534491 | 12553449 | 3 | 201511 | 0 |