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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122493442 | 12249344 | 2 | F | 20151020 | 20160818 | 20160408 | 20160823 | EXP | IT-TAKEDA-2016MPI002512 | TAKEDA | 76.00 | YR | F | Y | 86.00000 | KG | 20160823 | MD | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122493442 | 12249344 | 1 | PS | VELCADE | BORTEZOMIB | 1 | Subcutaneous | 1.9 MG, 1/WEEK | 4370492 | 21602 | 1.9 | MG | INJECTION | /wk | |||||
| 122493442 | 12249344 | 2 | SS | VELCADE | BORTEZOMIB | 1 | Subcutaneous | 2.5 MG, UNK | 4370492 | 21602 | 2.5 | MG | INJECTION | ||||||
| 122493442 | 12249344 | 3 | SS | VELCADE | BORTEZOMIB | 1 | Subcutaneous | 1.9 MG, UNK | 4370492 | 21602 | 1.9 | MG | INJECTION | ||||||
| 122493442 | 12249344 | 4 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Intravenous (not otherwise specified) | 20 MG, UNK | Y | 0 | 20 | MG | |||||||
| 122493442 | 12249344 | 5 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 120 MG, UNK | U | 0 | 120 | MG | |||||||
| 122493442 | 12249344 | 6 | SS | DARATUMUMAB | DARATUMUMAB | 1 | Intravenous (not otherwise specified) | 1376 MG, 1/WEEK | Y | 4370774 | 0 | 1376 | MG | /wk | |||||
| 122493442 | 12249344 | 7 | SS | MELPHALAN | MELPHALAN | 1 | Oral | 17.28 MG, UNK | Y | 4370783 | 0 | 17.28 | MG | ||||||
| 122493442 | 12249344 | 8 | C | IRBESARTAN. | IRBESARTAN | 1 | Unknown | UNK | 0 | ||||||||||
| 122493442 | 12249344 | 9 | C | IDROCLOROTIAZIDE | HYDROCHLOROTHIAZIDE | 1 | Unknown | UNK | 0 | ||||||||||
| 122493442 | 12249344 | 10 | C | SOTALEX | SOTALOL | 1 | Unknown | UNK | 0 | ||||||||||
| 122493442 | 12249344 | 11 | C | CARDIOASPIRIN | ASPIRIN | 1 | Unknown | UNK | 0 | ||||||||||
| 122493442 | 12249344 | 12 | C | ALLOPURINOL. | ALLOPURINOL | 1 | Unknown | UNK | 0 | ||||||||||
| 122493442 | 12249344 | 13 | C | ANTRA /00661201/ | OMEPRAZOLE | 1 | Unknown | UNK | 0 | ||||||||||
| 122493442 | 12249344 | 14 | C | BACTRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Unknown | UNK | 0 | ||||||||||
| 122493442 | 12249344 | 15 | C | ZELITREX | VALACYCLOVIR HYDROCHLORIDE | 1 | Unknown | UNK | 0 | ||||||||||
| 122493442 | 12249344 | 16 | C | ZELITREX | VALACYCLOVIR HYDROCHLORIDE | 1 | Unknown | UNK | 0 | ||||||||||
| 122493442 | 12249344 | 17 | C | COAPROVEL | HYDROCHLOROTHIAZIDEIRBESARTAN | 1 | Unknown | UNK | 0 | ||||||||||
| 122493442 | 12249344 | 18 | C | PANTOPRAZOLE | PANTOPRAZOLE SODIUM | 1 | Unknown | UNK | 0 | ||||||||||
| 122493442 | 12249344 | 19 | C | ESKIM | OMEGA-3 FATTY ACIDS | 1 | Unknown | UNK | 0 | ||||||||||
| 122493442 | 12249344 | 20 | C | ARIXTRA | FONDAPARINUX SODIUM | 1 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122493442 | 12249344 | 1 | Plasma cell myeloma |
| 122493442 | 12249344 | 4 | Plasma cell myeloma |
| 122493442 | 12249344 | 5 | Plasma cell myeloma |
| 122493442 | 12249344 | 6 | Plasma cell myeloma |
| 122493442 | 12249344 | 7 | Plasma cell myeloma |
| 122493442 | 12249344 | 8 | Hypertension |
| 122493442 | 12249344 | 9 | Hypertension |
| 122493442 | 12249344 | 10 | Prophylaxis |
| 122493442 | 12249344 | 11 | Prophylaxis |
| 122493442 | 12249344 | 12 | Prophylaxis |
| 122493442 | 12249344 | 13 | Prophylaxis |
| 122493442 | 12249344 | 14 | Prophylaxis |
| 122493442 | 12249344 | 15 | Prophylaxis |
| 122493442 | 12249344 | 17 | Prophylaxis |
| 122493442 | 12249344 | 18 | Prophylaxis |
| 122493442 | 12249344 | 19 | Prophylaxis |
| 122493442 | 12249344 | 20 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122493442 | 12249344 | OT |
| 122493442 | 12249344 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122493442 | 12249344 | Atrial fibrillation | |
| 122493442 | 12249344 | Dyspnoea | |
| 122493442 | 12249344 | Hypocalcaemia | |
| 122493442 | 12249344 | Relapsing fever | |
| 122493442 | 12249344 | Thrombocytopenia | |
| 122493442 | 12249344 | Tremor |
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 |
|---|---|---|---|---|---|---|
| 122493442 | 12249344 | 1 | 20151020 | 0 | ||
| 122493442 | 12249344 | 2 | 20151023 | 0 | ||
| 122493442 | 12249344 | 3 | 20151201 | 0 | ||
| 122493442 | 12249344 | 4 | 20151020 | 20151201 | 0 | |
| 122493442 | 12249344 | 5 | 20151021 | 20151023 | 0 | |
| 122493442 | 12249344 | 6 | 20151020 | 20151201 | 0 | |
| 122493442 | 12249344 | 7 | 20151020 | 20151201 | 0 |