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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 97878963 | 9787896 | 3 | F | 20160725 | 20131230 | 20160802 | EXP | JP-JNJFOC-20131216288 | JANSSEN | HIGASHI Y, TADA K, YAMASUJI Y, SHIMOKAWA M, KANEKURA T. ELEVATION OF SERUM KL-6 IN PATIENTS WITH PSORIASIS TREATED WITH ANTI-TUMOUR NECROSIS FACTOR- THERAPY. CLINICAL AND EXPERIMENTAL DERMATOLOGY 2016;41(1):88-90. HIGASHI Y, TADA K, YAMASUJI Y, SHIMOKAWA M, KANEKURA T. A CASE OF PSORIATIC ARTHRITIS WITH ELEVATED KL-6 LEVEL UNDER ANTI-TNF-ALPHA THERAPY. THE 28TH ANNUAL MEETING OF THE JAPANESE SOCIETY FOR PSORIASIS RESEARCH 2013:195. | 50.00 | YR | A | M | Y | 0.00000 | 20160802 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 97878963 | 9787896 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | UNKNOWN | 0 | 5 | MG/KG | LYOPHILIZED POWDER | ||||||
| 97878963 | 9787896 | 2 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | UNKNOWN | 103772 | 5 | MG/KG | LYOPHILIZED POWDER | ||||||
| 97878963 | 9787896 | 3 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 0 | 4 | MG | UNSPECIFIED | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 97878963 | 9787896 | 1 | Pustular psoriasis |
| 97878963 | 9787896 | 2 | Psoriatic arthropathy |
| 97878963 | 9787896 | 3 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 97878963 | 9787896 | Cell marker increased | |
| 97878963 | 9787896 | Drug ineffective |
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 |
|---|---|---|---|---|---|---|
| 97878963 | 9787896 | 1 | 201003 | 0 | ||
| 97878963 | 9787896 | 2 | 201003 | 0 |