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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 86494694 | 8649469 | 4 | F | 20120410 | 20160815 | 20120705 | 20160826 | EXP | JP-JNJFOC-20120614016 | JANSSEN | KOHEI S. A CASE WHO DEVELOPED MALIGNANT LYMPHOMA DURING INFLIXIMAB THERAPY FOR BEHCET^S DISEASE. JOURNAL OF JAPANESE OPHTHALMOLOGICAL SOCIETY 2014;118 (5):440-445. AKAHOSHI M, UEDA A, TAKEDA A, MITOMA H, ARINOBU Y, NIIRO H, ET AL. 341: THERAPY WITH TNF INHIBITORS FOR OCULAR LESIONS OF BEHCET^S DISEASE: CONSIDERATION OF LONG-TERM (5 YEAR) RESULTS AND PROGNOSTIC FACTORS. THE JOURNAL OF THE JAPANESE SOCIETY OF INTERNAL MEDICINE 2016;105:231. | 61.90 | YR | A | M | Y | 51.00000 | KG | 20160826 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 86494694 | 8649469 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | 0 | 280 | MG | LYOPHILIZED POWDER | ||||||
| 86494694 | 8649469 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | 0 | 280 | MG | LYOPHILIZED POWDER | ||||||
| 86494694 | 8649469 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | 0 | 280 | MG | LYOPHILIZED POWDER | ||||||
| 86494694 | 8649469 | 4 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | 0 | 280 | MG | LYOPHILIZED POWDER | ||||||
| 86494694 | 8649469 | 5 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | 0 | 280 | MG | LYOPHILIZED POWDER | ||||||
| 86494694 | 8649469 | 6 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | 103772 | 280 | MG | LYOPHILIZED POWDER | ||||||
| 86494694 | 8649469 | 7 | SS | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Oral | 0 | 20 | MG | UNSPECIFIED | ||||||||
| 86494694 | 8649469 | 8 | SS | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Oral | 0 | 2 | MG | UNSPECIFIED | ||||||||
| 86494694 | 8649469 | 9 | SS | NEORAL | CYCLOSPORINE | 1 | Oral | 50 MG | Y | 0 | 100 | MG | UNSPECIFIED | ||||||
| 86494694 | 8649469 | 10 | C | COLCHICINE. | COLCHICINE | 1 | Oral | 0 | .5 | MG | UNSPECIFIED | ||||||||
| 86494694 | 8649469 | 11 | C | PARIET | RABEPRAZOLE SODIUM | 1 | Oral | 0 | 20 | MG | UNSPECIFIED | ||||||||
| 86494694 | 8649469 | 12 | C | ALFAROL | ALFACALCIDOL | 1 | Oral | 0 | .5 | UG | UNSPECIFIED | ||||||||
| 86494694 | 8649469 | 13 | C | BAYASPIRIN | ASPIRIN | 1 | Oral | 0 | 100 | MG | UNSPECIFIED | ||||||||
| 86494694 | 8649469 | 14 | C | MAGLAX | MAGNESIUM OXIDE | 1 | Oral | 0 | 250 | MG | UNSPECIFIED | ||||||||
| 86494694 | 8649469 | 15 | C | MAGLAX | MAGNESIUM OXIDE | 1 | Oral | 0 | 750 | MG | UNSPECIFIED | ||||||||
| 86494694 | 8649469 | 16 | C | METHYCOBAL | METHYLCOBALAMIN | 1 | Oral | 0 | 500 | MG | UNSPECIFIED | ||||||||
| 86494694 | 8649469 | 17 | C | METHYCOBAL | METHYLCOBALAMIN | 1 | Oral | 0 | 1500 | MG | UNSPECIFIED | ||||||||
| 86494694 | 8649469 | 18 | C | SANDIMMUN | CYCLOSPORINE | 1 | Oral | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 86494694 | 8649469 | 1 | Behcet's syndrome |
| 86494694 | 8649469 | 2 | Behcet's syndrome |
| 86494694 | 8649469 | 3 | Behcet's syndrome |
| 86494694 | 8649469 | 4 | Behcet's syndrome |
| 86494694 | 8649469 | 5 | Behcet's syndrome |
| 86494694 | 8649469 | 6 | Behcet's syndrome |
| 86494694 | 8649469 | 7 | Behcet's syndrome |
| 86494694 | 8649469 | 8 | Behcet's syndrome |
| 86494694 | 8649469 | 9 | Behcet's syndrome |
| 86494694 | 8649469 | 10 | Behcet's syndrome |
| 86494694 | 8649469 | 11 | Gastrooesophageal reflux disease |
| 86494694 | 8649469 | 12 | Osteoporosis |
| 86494694 | 8649469 | 13 | Behcet's syndrome |
| 86494694 | 8649469 | 14 | Constipation |
| 86494694 | 8649469 | 15 | Constipation |
| 86494694 | 8649469 | 16 | Hypoaesthesia |
| 86494694 | 8649469 | 17 | Hypoaesthesia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 86494694 | 8649469 | HO |
| 86494694 | 8649469 | LT |
| 86494694 | 8649469 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 86494694 | 8649469 | Cellulitis | |
| 86494694 | 8649469 | Decubitus ulcer | |
| 86494694 | 8649469 | Herpes zoster | |
| 86494694 | 8649469 | Lymphoma |
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 |
|---|---|---|---|---|---|---|
| 86494694 | 8649469 | 1 | 20071001 | 0 | ||
| 86494694 | 8649469 | 2 | 20070905 | 0 | ||
| 86494694 | 8649469 | 3 | 20070820 | 0 | ||
| 86494694 | 8649469 | 5 | 20071126 | 0 | ||
| 86494694 | 8649469 | 6 | 20080124 | 0 |