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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127037511 | 12703751 | 1 | I | 20160505 | 20160510 | 20160831 | 20160831 | PER | US-MYLANLABS-2016M1019691 | MYLAN | 82.18 | YR | F | Y | 57.60000 | KG | 20160831 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127037511 | 12703751 | 1 | PS | LIDOCAINE PATCH | LIDOCAINE | 1 | Cutaneous | 1 DF/ QD ON EACH SIDE OF BACK, 12 HRS ON, 12 HRS OFF | 615209 | 202346 | 1 | DF | CUTANEOUS PATCH | QD | |||||
| 127037511 | 12703751 | 2 | SS | LIDOCAINE PATCH | LIDOCAINE | 1 | Cutaneous | 1 DF/ QD ON EACH SIDE OF BACK, 12 HRS ON, 12 HRS OFF | 615227 | 202346 | 1 | DF | CUTANEOUS PATCH | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127037511 | 12703751 | 1 | Arthralgia |
| 127037511 | 12703751 | 2 | Off label use |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127037511 | 12703751 | Drug ineffective for unapproved indication | |
| 127037511 | 12703751 | Product adhesion issue | |
| 127037511 | 12703751 | Product quality issue |
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 |
|---|---|---|---|---|---|---|
| 127037511 | 12703751 | 1 | 20160505 | 0 | ||
| 127037511 | 12703751 | 2 | 20160505 | 0 |