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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125518382 | 12551838 | 2 | F | 20160525 | 20160713 | 20160714 | EXP | JP-009507513-1607JPN004112 | MERCK | 70.00 | YR | F | Y | 0.00000 | 20160714 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125518382 | 12551838 | 1 | PS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Subcutaneous | 20 MG/KG BODY WEIGHT, UNK | 12675 | 20 | MG/KG | INJECTION | |||||||
| 125518382 | 12551838 | 2 | SS | BORTEZOMIB | BORTEZOMIB | 1 | Subcutaneous | 1.3 MG/M2, UNK | 0 | 1.3 | MG/M**2 | ||||||||
| 125518382 | 12551838 | 3 | SS | BORTEZOMIB | BORTEZOMIB | 1 | 0 | ||||||||||||
| 125518382 | 12551838 | 4 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | 300 MG/M2, UNK | 0 | 300 | MG/M**2 | ||||||||
| 125518382 | 12551838 | 5 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125518382 | 12551838 | 1 | Light chain disease |
| 125518382 | 12551838 | 2 | Chemotherapy |
| 125518382 | 12551838 | 3 | Light chain disease |
| 125518382 | 12551838 | 4 | Chemotherapy |
| 125518382 | 12551838 | 5 | Light chain disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125518382 | 12551838 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125518382 | 12551838 | Drug ineffective | |
| 125518382 | 12551838 | Hepatotoxicity | |
| 125518382 | 12551838 | Off label use |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |