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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126152903 | 12615290 | 3 | F | 201106 | 20160908 | 20160802 | 20160913 | EXP | PT-JNJFOC-20160724287 | JANSSEN | ANDRADE P, LOPES S, COELHO R, TERROSO G, LAGE J, MACEDO G. SQUAMOUS CELL CARCINOMA ARISING FROM A PRESACRAL CYST IN A PATIENT WITH ULCERATIVE COLITIS UNDER AZATHIOPRINE AND INFLIXIMAB: FIRST CASE REPORT. INT J COLORECTAL DIS 2016;31 (8):1509 - 10. | 58.71 | YR | A | F | Y | 0.00000 | 20160913 | MD | PT | PT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126152903 | 12615290 | 1 | PS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | 103772 | 5 | MG/KG | LYOPHILIZED POWDER | ||||||
| 126152903 | 12615290 | 2 | SS | AZATHIOPRINE. | AZATHIOPRINE | 1 | Oral | U | 0 | 2.2 | MG/KG | UNSPECIFIED | |||||||
| 126152903 | 12615290 | 3 | SS | MESALAZINE | MESALAMINE | 1 | Oral | U | 0 | 3 | G | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126152903 | 12615290 | 1 | Colitis ulcerative |
| 126152903 | 12615290 | 2 | Colitis ulcerative |
| 126152903 | 12615290 | 3 | Colitis ulcerative |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126152903 | 12615290 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126152903 | 12615290 | Off label use | |
| 126152903 | 12615290 | Product use issue | |
| 126152903 | 12615290 | Squamous cell carcinoma |
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 |
|---|---|---|---|---|---|---|
| 126152903 | 12615290 | 1 | 201106 | 201412 | 0 | |
| 126152903 | 12615290 | 2 | 200604 | 0 | ||
| 126152903 | 12615290 | 3 | 200604 | 0 |