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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122971474 | 12297147 | 4 | F | 20160707 | 20160422 | 20160712 | EXP | FR-JNJFOC-20160416917 | JANSSEN | 39.00 | YR | A | M | Y | 87.00000 | KG | 20160712 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122971474 | 12297147 | 1 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | U | U | 103772 | 400 | MG | LYOPHILIZED POWDER | QOW | |||||
| 122971474 | 12297147 | 2 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Intravenous (not otherwise specified) | 0 | 40 | MG | UNSPECIFIED | QD | |||||||
| 122971474 | 12297147 | 3 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 0 | 40 | MG | UNSPECIFIED | QD | |||||||
| 122971474 | 12297147 | 4 | C | LOVENOX | ENOXAPARIN SODIUM | 1 | Subcutaneous | 0 | 400 | MG | UNSPECIFIED | QD | |||||||
| 122971474 | 12297147 | 5 | C | SPASFON | PHLOROGLUCINOL | 1 | Oral | 0 | 40 | MG | UNSPECIFIED | QD | |||||||
| 122971474 | 12297147 | 6 | C | CEFOTAXIME | CEFOTAXIME SODIUM | 1 | Intravenous (not otherwise specified) | 0 | 1 | G | UNSPECIFIED | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122971474 | 12297147 | 1 | Colitis ulcerative |
| 122971474 | 12297147 | 2 | Colitis ulcerative |
| 122971474 | 12297147 | 3 | Colitis ulcerative |
| 122971474 | 12297147 | 4 | Prophylaxis |
| 122971474 | 12297147 | 5 | Pain |
| 122971474 | 12297147 | 6 | Colitis ulcerative |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122971474 | 12297147 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122971474 | 12297147 | Colitis ulcerative |
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 |
|---|---|---|---|---|---|---|
| 122971474 | 12297147 | 1 | 20090502 | 20090518 | 0 | |
| 122971474 | 12297147 | 2 | 20090523 | 20090605 | 0 | |
| 122971474 | 12297147 | 3 | 200904 | 20090522 | 0 | |
| 122971474 | 12297147 | 4 | 200904 | 20090603 | 0 | |
| 122971474 | 12297147 | 5 | 20090516 | 20090705 | 0 | |
| 122971474 | 12297147 | 6 | 20090513 | 20090705 | 0 |