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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125915911 | 12591591 | 1 | I | 201508 | 20160511 | 20160726 | 20160726 | EXP | US-SHIRE-US201605805 | SHIRE | 73.34 | YR | F | Y | 0.00000 | 20160726 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125915911 | 12591591 | 1 | PS | PENTASA | MESALAMINE | 1 | Oral | 500 MG (8 CAPS), UNKNOWN (A DAY) | 20049 | 500 | MG | CAPSULE | |||||||
125915911 | 12591591 | 2 | SS | PENTASA | MESALAMINE | 1 | Oral | UNK | 20049 | CAPSULE |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
125915911 | 12591591 | 1 | Colitis ulcerative |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
125915911 | 12591591 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
125915911 | 12591591 | Chills | |
125915911 | 12591591 | Colitis ulcerative | |
125915911 | 12591591 | Diarrhoea | |
125915911 | 12591591 | Drug ineffective | |
125915911 | 12591591 | Gastrointestinal haemorrhage | |
125915911 | 12591591 | Nausea |
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 |
---|---|---|---|---|---|---|
125915911 | 12591591 | 1 | 201508 | 2016 | 0 | |
125915911 | 12591591 | 2 | 2016 | 0 |