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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 88191216 | 8819121 | 6 | F | 20111007 | 20160705 | 20121001 | 20160802 | EXP | JP-JNJFOC-20120912435 | JANSSEN | HIGASHI Y, SHIMOKAWA M, YAMASUJI Y, KAWAI K, KANEKURA T. A CASE OF A PATIENT WITH PUSTULAR PSORIASIS WHOSE KL-6 LEVEL INCREASED DURING INFLIXIMAB THERAPY. THE 27TH ANNUAL MEETING OF THE JAPANESE SOCIETY FOR PSORIASIS RESEARCH 2012;(-):215. HIGASHI Y, TADA K, SHIMOKAWA M, KAWAI K, KANEKURA T. ELEVATION OF SERUM KL-6 IN PATIENTS WITH PSORIASIS TREATED WITH ANTI-TUMOUR NECROSIS FACTOR-ALPHA THERAPY. CLINICAL AND EXPERIMENTAL DERMATOLOGY 2016;41 (NO. 1):88 - 90. | 58.98 | YR | A | F | Y | 52.00000 | KG | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 88191216 | 8819121 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | 0 | 5 | MG/KG | LYOPHILIZED POWDER | ||||||
| 88191216 | 8819121 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | 0 | 230 | MG | LYOPHILIZED POWDER | ||||||
| 88191216 | 8819121 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | 0 | 230 | MG | LYOPHILIZED POWDER | ||||||
| 88191216 | 8819121 | 4 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | 0 | 5 | MG/KG | LYOPHILIZED POWDER | ||||||
| 88191216 | 8819121 | 5 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | 0 | 230 | MG | LYOPHILIZED POWDER | ||||||
| 88191216 | 8819121 | 6 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | 103772 | 230 | MG | LYOPHILIZED POWDER | ||||||
| 88191216 | 8819121 | 7 | C | LOXONIN | LOXOPROFEN SODIUM | 1 | Oral | 0 | 60 | MG | UNSPECIFIED | ||||||||
| 88191216 | 8819121 | 8 | C | MUCOSTA | REBAMIPIDE | 1 | Oral | 0 | 100 | MG | UNSPECIFIED | ||||||||
| 88191216 | 8819121 | 9 | C | ALLELOCK | OLOPATADINE HYDROCHLORIDE | 1 | Oral | 0 | 10 | MG | UNSPECIFIED | ||||||||
| 88191216 | 8819121 | 10 | C | GASTER | FAMOTIDINE | 1 | Oral | 0 | 20 | MG | UNSPECIFIED | ||||||||
| 88191216 | 8819121 | 11 | C | LENDORMIN D | BROTIZOLAM | 1 | Oral | 0 | .25 | MG | UNSPECIFIED | ||||||||
| 88191216 | 8819121 | 12 | C | OXAROL | MAXACALCITOL | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 88191216 | 8819121 | 13 | C | RINDERON VG | BETAMETHASONE VALERATEGENTAMICIN SULFATE | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 88191216 | 8819121 | 1 | Pustular psoriasis |
| 88191216 | 8819121 | 2 | Pustular psoriasis |
| 88191216 | 8819121 | 3 | Pustular psoriasis |
| 88191216 | 8819121 | 4 | Pustular psoriasis |
| 88191216 | 8819121 | 5 | Pustular psoriasis |
| 88191216 | 8819121 | 6 | Pustular psoriasis |
| 88191216 | 8819121 | 7 | Arthralgia |
| 88191216 | 8819121 | 8 | Gastritis |
| 88191216 | 8819121 | 9 | Pustular psoriasis |
| 88191216 | 8819121 | 10 | Gastritis |
| 88191216 | 8819121 | 11 | Insomnia |
| 88191216 | 8819121 | 12 | Pustular psoriasis |
| 88191216 | 8819121 | 13 | Pustular psoriasis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 88191216 | 8819121 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 88191216 | 8819121 | Diffuse alveolar damage | |
| 88191216 | 8819121 | Interstitial lung disease | |
| 88191216 | 8819121 | Pyrexia |
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 |
|---|---|---|---|---|---|---|
| 88191216 | 8819121 | 1 | 201110 | 0 | ||
| 88191216 | 8819121 | 2 | 20111007 | 0 | ||
| 88191216 | 8819121 | 3 | 20111117 | 0 | ||
| 88191216 | 8819121 | 4 | 201110 | 0 | ||
| 88191216 | 8819121 | 5 | 20111117 | 0 | ||
| 88191216 | 8819121 | 6 | 20111007 | 0 | ||
| 88191216 | 8819121 | 7 | 20110802 | 20120819 | 0 | |
| 88191216 | 8819121 | 8 | 20110802 | 20120819 | 0 | |
| 88191216 | 8819121 | 9 | 20110811 | 0 | ||
| 88191216 | 8819121 | 10 | 20110816 | 20120819 | 0 | |
| 88191216 | 8819121 | 11 | 20110816 | 20120213 | 0 | |
| 88191216 | 8819121 | 12 | 20110817 | 0 | ||
| 88191216 | 8819121 | 13 | 20111117 | 0 |