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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113364624 | 11336462 | 4 | F | 20080801 | 20160920 | 20150804 | 20160922 | EXP | FR-JNJFOC-20150715035 | JANSSEN | 43.00 | YR | A | M | Y | 99.00000 | KG | 20160922 | MD | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113364624 | 11336462 | 1 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | UNKNOWN | 103772 | LYOPHILIZED POWDER | |||||||
| 113364624 | 11336462 | 2 | SS | USTEKINUMAB | USTEKINUMAB | 1 | Subcutaneous | Y | N | UNKNOWN | 125261 | SOLUTION FOR INJECTION | |||||||
| 113364624 | 11336462 | 3 | SS | HUMIRA | ADALIMUMAB | 1 | Unknown | Y | 0 | UNSPECIFIED | |||||||||
| 113364624 | 11336462 | 4 | SS | GSK1605786A | VERCIRNON SODIUM | 1 | Unknown | Y | 0 | UNSPECIFIED | |||||||||
| 113364624 | 11336462 | 5 | SS | GSK1605786A | VERCIRNON SODIUM | 1 | Unknown | Y | 0 | UNSPECIFIED | |||||||||
| 113364624 | 11336462 | 6 | SS | GSK1605786A | VERCIRNON SODIUM | 1 | Unknown | Y | 0 | 225 | MG | UNSPECIFIED | |||||||
| 113364624 | 11336462 | 7 | SS | GSK1605786A | VERCIRNON SODIUM | 1 | Unknown | Y | 0 | UNSPECIFIED | |||||||||
| 113364624 | 11336462 | 8 | SS | GSK1605786A | VERCIRNON SODIUM | 1 | Unknown | Y | 0 | UNSPECIFIED | |||||||||
| 113364624 | 11336462 | 9 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | Y | 0 | 7 | MG | UNSPECIFIED | BID | ||||||
| 113364624 | 11336462 | 10 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Unknown | Y | 0 | UNSPECIFIED | |||||||||
| 113364624 | 11336462 | 11 | SS | IMUREL | AZATHIOPRINE SODIUM | 1 | Unknown | Y | 0 | UNSPECIFIED | |||||||||
| 113364624 | 11336462 | 12 | SS | CIMZIA | CERTOLIZUMAB PEGOL | 1 | Unknown | Y | 0 | UNSPECIFIED | |||||||||
| 113364624 | 11336462 | 13 | C | OROCAL D3 | CALCIUM CARBONATECHOLECALCIFEROL | 1 | Unknown | D | 0 | 400 | MG | UNSPECIFIED | QD | ||||||
| 113364624 | 11336462 | 14 | C | HYDROCORTISONE. | HYDROCORTISONE | 1 | Unknown | D | 0 | 30 | MG | UNSPECIFIED | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113364624 | 11336462 | 1 | Product used for unknown indication |
| 113364624 | 11336462 | 2 | Product used for unknown indication |
| 113364624 | 11336462 | 3 | Product used for unknown indication |
| 113364624 | 11336462 | 4 | Crohn's disease |
| 113364624 | 11336462 | 5 | Crohn's disease |
| 113364624 | 11336462 | 6 | Crohn's disease |
| 113364624 | 11336462 | 7 | Crohn's disease |
| 113364624 | 11336462 | 8 | Crohn's disease |
| 113364624 | 11336462 | 9 | Crohn's disease |
| 113364624 | 11336462 | 10 | Product used for unknown indication |
| 113364624 | 11336462 | 11 | Product used for unknown indication |
| 113364624 | 11336462 | 12 | Product used for unknown indication |
| 113364624 | 11336462 | 13 | Osteoporosis prophylaxis |
| 113364624 | 11336462 | 14 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113364624 | 11336462 | HO |
| 113364624 | 11336462 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113364624 | 11336462 | Adenocarcinoma of colon | |
| 113364624 | 11336462 | Arthritis | |
| 113364624 | 11336462 | Basal cell carcinoma | |
| 113364624 | 11336462 | Drug ineffective | |
| 113364624 | 11336462 | Inguinal hernia |
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 |
|---|---|---|---|---|---|---|
| 113364624 | 11336462 | 1 | 200706 | 201003 | 0 | |
| 113364624 | 11336462 | 2 | 201209 | 201304 | 0 | |
| 113364624 | 11336462 | 3 | 201005 | 201107 | 0 | |
| 113364624 | 11336462 | 4 | 20131220 | 0 | ||
| 113364624 | 11336462 | 5 | 20131127 | 0 | ||
| 113364624 | 11336462 | 6 | 20091028 | 20091221 | 0 | |
| 113364624 | 11336462 | 7 | 20120120 | 20120607 | 0 | |
| 113364624 | 11336462 | 9 | 20141127 | 201503 | 0 | |
| 113364624 | 11336462 | 10 | 201305 | 201308 | 0 | |
| 113364624 | 11336462 | 11 | 200511 | 200904 | 0 | |
| 113364624 | 11336462 | 12 | 200605 | 200705 | 0 | |
| 113364624 | 11336462 | 13 | 20131127 | 0 | ||
| 113364624 | 11336462 | 14 | 20141115 | 0 |