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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
126076492 | 12607649 | 2 | F | 20160721 | 20160727 | 20160729 | 20160803 | EXP | FR-JNJFOC-20160722374 | JANSSEN | 69.00 | YR | E | M | Y | 60.00000 | KG | 20160803 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
126076492 | 12607649 | 1 | PS | DARATUMUMAB | DARATUMUMAB | 1 | Intravenous (not otherwise specified) | U | U | 761036 | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||||
126076492 | 12607649 | 2 | SS | DARATUMUMAB | DARATUMUMAB | 1 | Intravenous (not otherwise specified) | MEDICINE KIT NUMBER: 4371676 | U | U | 100638 | 1040 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||
126076492 | 12607649 | 3 | SS | LENALIDOMIDE | LENALIDOMIDE | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
126076492 | 12607649 | 4 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | U | 0 | 40 | MG | UNSPECIFIED |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
126076492 | 12607649 | 2 | Plasma cell myeloma |
126076492 | 12607649 | 3 | Plasma cell myeloma |
126076492 | 12607649 | 4 | Plasma cell myeloma |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
126076492 | 12607649 | HO |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
126076492 | 12607649 | Cardiac murmur | |
126076492 | 12607649 | Dyspnoea exertional | |
126076492 | 12607649 | Pneumonia |
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 |
---|---|---|---|---|---|---|
126076492 | 12607649 | 2 | 20160721 | 0 | ||
126076492 | 12607649 | 4 | 20160721 | 0 |