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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127146511 | 12714651 | 1 | I | 201608 | 20160825 | 20160905 | 20160905 | EXP | CA-JNJFOC-20160822743 | JANSSEN | 0.00 | N | M | Y | 3.20000 | KG | 20160905 | OT | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127146511 | 12714651 | 1 | PS | REMICADE | INFLIXIMAB | 1 | Transplacental | N | 103772 | LYOPHILIZED POWDER | |||||||||
| 127146511 | 12714651 | 2 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127146511 | 12714651 | 1 | Colitis ulcerative |
| 127146511 | 12714651 | 2 | Colitis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127146511 | 12714651 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127146511 | 12714651 | Foetal exposure during pregnancy | |
| 127146511 | 12714651 | Lung infection |
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 |
|---|---|---|---|---|---|---|
| 127146511 | 12714651 | 1 | 20160715 | 0 | ||
| 127146511 | 12714651 | 2 | 20160615 | 0 |