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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124696182 | 12469618 | 2 | F | 20160607 | 20160802 | 20160615 | 20160804 | EXP | FR-JNJFOC-20160609069 | JANSSEN | 63.31 | YR | A | F | Y | 70.00000 | KG | 20160804 | MD | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124696182 | 12469618 | 1 | PS | DARATUMUMAB | DARATUMUMAB | 1 | Intravenous (not otherwise specified) | N | N | 100638 | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||||
| 124696182 | 12469618 | 2 | SS | DARATUMUMAB | DARATUMUMAB | 1 | Intravenous (not otherwise specified) | N | N | 761036 | 1100 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||
| 124696182 | 12469618 | 3 | SS | VELCADE | BORTEZOMIB | 1 | Subcutaneous | N | 0 | 1.3 | MG/M**2 | LYOPHILIZED POWDER | |||||||
| 124696182 | 12469618 | 4 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | N | 0 | 40 | MG | UNSPECIFIED | |||||||
| 124696182 | 12469618 | 5 | SS | THALIDOMIDE | THALIDOMIDE | 1 | Oral | N | 0 | 100 | MG | UNSPECIFIED | QD | ||||||
| 124696182 | 12469618 | 6 | C | VALACICLOVIR | VALACYCLOVIR HYDROCHLORIDE | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124696182 | 12469618 | 2 | Plasma cell myeloma |
| 124696182 | 12469618 | 3 | Plasma cell myeloma |
| 124696182 | 12469618 | 4 | Plasma cell myeloma |
| 124696182 | 12469618 | 5 | Plasma cell myeloma |
| 124696182 | 12469618 | 6 | Herpes zoster |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124696182 | 12469618 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124696182 | 12469618 | Herpes zoster |
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 |
|---|---|---|---|---|---|---|
| 124696182 | 12469618 | 2 | 20160308 | 20160509 | 0 | |
| 124696182 | 12469618 | 3 | 20160308 | 20160513 | 0 | |
| 124696182 | 12469618 | 4 | 20160308 | 20160518 | 0 | |
| 124696182 | 12469618 | 5 | 20160308 | 20160517 | 0 | |
| 124696182 | 12469618 | 6 | 20160517 | 0 |