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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125565922 | 12556592 | 2 | F | 20160825 | 20160714 | 20160830 | EXP | US-JNJFOC-20160707345 | JANSSEN | MOSTAMAND S, SCHROEDER S, SCHENKEIN J, MILOH T. INFLIXIMAB-ASSOCIATED IMMUNOMEDIATED HEPATITIS IN CHILDREN WITH INFLAMMATORY BOWELDISEASE.. J PEDIATR GASTROENTEROL NUTR 2016;63 (1):94-97. | 15.00 | YR | T | F | Y | 0.00000 | 20160830 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125565922 | 12556592 | 1 | SS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | UNKNOWN | 0 | 5 | MG/KG | LYOPHILIZED POWDER | |||||
| 125565922 | 12556592 | 2 | SS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | UNKNOWN | 0 | 10 | MG/KG | LYOPHILIZED POWDER | |||||
| 125565922 | 12556592 | 3 | SS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | UNKNOWN | 0 | LYOPHILIZED POWDER | |||||||
| 125565922 | 12556592 | 4 | PS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | UNKNOWN | 103772 | 100 | MG/KG | LYOPHILIZED POWDER | |||||
| 125565922 | 12556592 | 5 | SS | AZATHIOPRINE. | AZATHIOPRINE | 1 | Unknown | U | 0 | UNKNOWN | |||||||||
| 125565922 | 12556592 | 6 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 3 WEEKS TOTAL | 0 | 30 | MG | UNSPECIFIED | Q12H |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125565922 | 12556592 | 1 | Colitis ulcerative |
| 125565922 | 12556592 | 2 | Colitis ulcerative |
| 125565922 | 12556592 | 3 | Colitis ulcerative |
| 125565922 | 12556592 | 4 | Colitis ulcerative |
| 125565922 | 12556592 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125565922 | 12556592 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125565922 | 12556592 | Autoimmune hepatitis | |
| 125565922 | 12556592 | Colitis ulcerative | |
| 125565922 | 12556592 | Dizziness | |
| 125565922 | 12556592 | Drug level decreased | |
| 125565922 | 12556592 | Drug resistance | |
| 125565922 | 12556592 | Fatigue | |
| 125565922 | 12556592 | Off label use | |
| 125565922 | 12556592 | Palpitations | |
| 125565922 | 12556592 | Product use issue |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |