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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
126079241 | 12607924 | 1 | I | 201506 | 20150717 | 20160729 | 20160729 | EXP | US-MYLANLABS-2015M1024435 | MYLAN | 17.76 | YR | M | Y | 0.00000 | 20160729 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
126079241 | 12607924 | 1 | PS | AMNESTEEM | ISOTRETINOIN | 1 | Oral | 40 MG, BID | Y | N | 75945 | 40 | MG | CAPSULE | BID | ||||
126079241 | 12607924 | 2 | SS | AMNESTEEM | ISOTRETINOIN | 1 | Oral | 40 MG, BID | Y | N | 75945 | 40 | MG | CAPSULE | BID |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
126079241 | 12607924 | 1 | Acne |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
126079241 | 12607924 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
126079241 | 12607924 | Staphylococcal infection |
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 |
---|---|---|---|---|---|---|
126079241 | 12607924 | 1 | 201504 | 201506 | 0 | |
126079241 | 12607924 | 2 | 20150713 | 0 |