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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123818183 | 12381818 | 3 | F | 201404 | 20160628 | 20160518 | 20160705 | EXP | US-JNJFOC-20160510368 | JANSSEN | SUNSERI WM, KUGATHASAN S, KELJO DJ, GREER JB, RANGANATHAN S, CROSS RK, ET AL. IBD LIVE CASE SERIES - CASE 3: VERY EARLY-ONSET INFLAMMATORY BOWEL DISEASE: WHEN GENETIC TESTING PROVES BENEFICIAL. INFLAMM BOWEL DIS DEC-2015;21 (12):2958-2968. | 8.00 | YR | C | M | Y | 0.00000 | 20160705 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123818183 | 12381818 | 1 | SS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | UNKNOWN | 0 | 10 | MG/KG | LYOPHILIZED POWDER | |||||
| 123818183 | 12381818 | 2 | SS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | UNKNOWN | 0 | 5 | MG/KG | LYOPHILIZED POWDER | |||||
| 123818183 | 12381818 | 3 | SS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | UNKNOWN | 0 | 10 | MG/KG | LYOPHILIZED POWDER | |||||
| 123818183 | 12381818 | 4 | SS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | AT 0, 2, AND 6 WEEKS | Y | N | UNKNOWN | 0 | 5 | MG/KG | LYOPHILIZED POWDER | ||||
| 123818183 | 12381818 | 5 | SS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | UNKNOWN | 0 | 10 | MG/KG | LYOPHILIZED POWDER | |||||
| 123818183 | 12381818 | 6 | PS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | UNKNOWN | 103772 | 10 | MG/KG | LYOPHILIZED POWDER | /wk | ||||
| 123818183 | 12381818 | 7 | SS | ADALIMUMAB | ADALIMUMAB | 1 | Unknown | Y | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123818183 | 12381818 | 1 | Crohn's disease |
| 123818183 | 12381818 | 2 | Crohn's disease |
| 123818183 | 12381818 | 3 | Crohn's disease |
| 123818183 | 12381818 | 4 | Crohn's disease |
| 123818183 | 12381818 | 5 | Crohn's disease |
| 123818183 | 12381818 | 6 | Crohn's disease |
| 123818183 | 12381818 | 7 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123818183 | 12381818 | HO |
| 123818183 | 12381818 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123818183 | 12381818 | Cellulitis | |
| 123818183 | 12381818 | Chills | |
| 123818183 | 12381818 | Colitis | |
| 123818183 | 12381818 | Crohn's disease | |
| 123818183 | 12381818 | Drug effect incomplete | |
| 123818183 | 12381818 | Drug level below therapeutic | |
| 123818183 | 12381818 | Drug specific antibody present | |
| 123818183 | 12381818 | Fatigue | |
| 123818183 | 12381818 | Hereditary disorder | |
| 123818183 | 12381818 | Histiocytosis haematophagic | |
| 123818183 | 12381818 | Hypophagia | |
| 123818183 | 12381818 | Leukopenia | |
| 123818183 | 12381818 | Mental status changes | |
| 123818183 | 12381818 | Off label use | |
| 123818183 | 12381818 | Product use issue | |
| 123818183 | 12381818 | Psoriasis | |
| 123818183 | 12381818 | Pyrexia | |
| 123818183 | 12381818 | Rash morbilliform | |
| 123818183 | 12381818 | Staphylococcal 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 |
|---|---|---|---|---|---|---|
| 123818183 | 12381818 | 3 | 201405 | 0 | ||
| 123818183 | 12381818 | 4 | 201308 | 0 | ||
| 123818183 | 12381818 | 5 | 201406 | 0 | ||
| 123818183 | 12381818 | 6 | 201407 | 0 |