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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123063852 | 12306385 | 2 | F | 20160624 | 20160426 | 20160704 | EXP | JP-JNJFOC-20160420146 | JANSSEN | MORI T. A CASE OF INTRACTABLE DERMATOMYOSITIS WITH VARIOUS SYMPTOMS SUCH AS CALCINOSIS AND ACQUIRED BROWN^S SYNDROME SUCCESSFULLY TREATED WITH ADALIMUMAB. THE 60TH ANNUAL GENERAL ASSEMBLY AND SCIENTIFIC MEETING OF THE JAPAN COLLEGE OF RHEUMATOLOGY APR-2016:653. | 48.00 | YR | A | F | Y | 0.00000 | 20160704 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123063852 | 12306385 | 1 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | UNSPECIFIED | 103772 | LYOPHILIZED POWDER |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123063852 | 12306385 | 1 | Dermatomyositis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123063852 | 12306385 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123063852 | 12306385 | Drug ineffective | |
| 123063852 | 12306385 | Human antichimeric antibody positive | |
| 123063852 | 12306385 | Infusion related reaction | |
| 123063852 | 12306385 | Myalgia | |
| 123063852 | 12306385 | Off label use | |
| 123063852 | 12306385 | Panniculitis | |
| 123063852 | 12306385 | Product use issue | |
| 123063852 | 12306385 | Pyrexia | |
| 123063852 | 12306385 | Strabismus | |
| 123063852 | 12306385 | Surgery | |
| 123063852 | 12306385 | Therapeutic response unexpected |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |