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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
127033502 | 12703350 | 2 | F | 2014 | 20160927 | 20160831 | 20160930 | PER | US-SHIRE-US201611415 | SHIRE | 9.40 | YR | M | Y | 22.68000 | KG | 20160930 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
127033502 | 12703350 | 1 | PS | PENTASA | MESALAMINE | 1 | Oral | 500 MG, 1X/DAY:QD | U | U | 20049 | 500 | MG | CAPSULE | QD | ||||
127033502 | 12703350 | 2 | SS | SINGULAIR | MONTELUKAST SODIUM | 1 | Oral | 5 MG, 1X/DAY:QD | 0 | 5 | MG | QD | |||||||
127033502 | 12703350 | 3 | C | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | UNK UNK, OTHER(Q 6 WEEKS) | D | 0 |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
127033502 | 12703350 | 1 | Crohn's disease |
127033502 | 12703350 | 2 | Product used for unknown indication |
127033502 | 12703350 | 3 | Product used for unknown indication |
Outcome of event
no results found |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
127033502 | 12703350 | Drug eruption | |
127033502 | 12703350 | Product use 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 |
---|---|---|---|---|---|---|
127033502 | 12703350 | 1 | 2014 | 2016 | 0 |