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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125576431 | 12557643 | 1 | I | 20160705 | 20160714 | 20160714 | EXP | DK-JNJFOC-20160709307 | JANSSEN | JULSGAARD M, CHRISTENSEN LA, GIBSON PR, GEARRY RB, FALLINGBORG J, HVAS CL, ET AL. CONCENTRATIONS OF ADALIMUMAB AND INFLIXIMAB IN MOTHERS AND NEWBORNS, AND EFFECTS ON INFECTION. GASTROENTEROLOGY 2016;151:110-119. | 0.00 | Y | 0.00000 | 20160714 | OT | DK | DK |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125576431 | 12557643 | 1 | PS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 103772 | LYOPHILIZED POWDER |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125576431 | 12557643 | 1 | Inflammatory bowel disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125576431 | 12557643 | CA |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125576431 | 12557643 | Drug specific antibody present | |
| 125576431 | 12557643 | Foetal exposure during pregnancy | |
| 125576431 | 12557643 | Vascular malformation |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |