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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125413481 | 12541348 | 1 | I | 20160621 | 20160708 | 20160708 | EXP | JP-JNJFOC-20160704817 | JANSSEN | HIBI T, SHUNSEI H, HIROTOSHI K, UKIHIDE T, NORIKO S, KUNIHIKO O, ET AL. INFLIXIMAB THERAPY FOR INTESTINAL, NEUROLOGICAL, AND VASCULAR INVOLVEMENT IN BEHCET DISEASE: EFFICACY,SAFETY, AND PHARMACOKINETICS IN A MULTICENTER,PROSPECTIVE, OPEN-LABEL, SINGLE-ARM PHASE 3 STUDY. CLINICAL TRIAL/EXPERIMENTAL STUDY 2016;95 (24):E3863. | 0.00 | Y | 0.00000 | 20160708 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125413481 | 12541348 | 1 | SS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 0 | 10 | MG/KG | LYOPHILIZED POWDER | |||||||
| 125413481 | 12541348 | 2 | PS | INFLIXIMAB, RECOMBINANT | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 103772 | 5 | MG/KG | LYOPHILIZED POWDER |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125413481 | 12541348 | 1 | Behcet's syndrome |
| 125413481 | 12541348 | 2 | Behcet's syndrome |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125413481 | 12541348 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125413481 | 12541348 | Abdominal pain | |
| 125413481 | 12541348 | Behcet's syndrome | |
| 125413481 | 12541348 | C-reactive protein increased | |
| 125413481 | 12541348 | Diarrhoea | |
| 125413481 | 12541348 | Melaena | |
| 125413481 | 12541348 | Pyrexia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |