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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123528152 | 12352815 | 2 | F | 20160328 | 20160811 | 20160510 | 20160819 | EXP | AR-TAKEDA-2016MPI003889 | TAKEDA | 60.32 | YR | F | Y | 53.00000 | KG | 20160819 | MD | AR | AR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123528152 | 12352815 | 1 | PS | VELCADE | BORTEZOMIB | 1 | Subcutaneous | 1.95 MG, UNK | 4370492 | 21602 | 1.95 | MG | INJECTION | ||||||
| 123528152 | 12352815 | 2 | SS | VELCADE | BORTEZOMIB | 1 | Subcutaneous | 1.95 MG, UNK | 4370492 | 21602 | 1.95 | MG | INJECTION | ||||||
| 123528152 | 12352815 | 3 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 90 MG, UNK | Y | 4371073;4371050 | 0 | 90 | MG | ||||||
| 123528152 | 12352815 | 4 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 90 MG, UNK | Y | 4371073;4371050 | 0 | 90 | MG | ||||||
| 123528152 | 12352815 | 5 | SS | MELPHALAN | MELPHALAN | 1 | Oral | 14 MG, UNK | Y | 4371043 | 0 | 14 | MG | ||||||
| 123528152 | 12352815 | 6 | SS | MELPHALAN | MELPHALAN | 1 | Oral | 14 MG, UNK | Y | 4371043 | 0 | 14 | MG | ||||||
| 123528152 | 12352815 | 7 | C | FLUCONAZOL | FLUCONAZOLE | 1 | Oral | 0 | 150 | MG | CAPSULE | ||||||||
| 123528152 | 12352815 | 8 | C | ACICLOVIR | ACYCLOVIR | 1 | Oral | 0 | 800 | MG | TABLET | ||||||||
| 123528152 | 12352815 | 9 | C | LACTULOSA | LACTULOSE | 1 | Oral | 0 | 10 | ML | ORAL LIQUID | BID | |||||||
| 123528152 | 12352815 | 10 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Intravenous (not otherwise specified) | 0 | 500 | MG | INJECTION | ||||||||
| 123528152 | 12352815 | 11 | C | PIPERACILLIN/TAZOBACTAM | PIPERACILLIN SODIUMTAZOBACTAM SODIUM | 1 | Intravenous (not otherwise specified) | 0 | 4.5 | G | INJECTION | TID | |||||||
| 123528152 | 12352815 | 12 | C | ULTIBRO | GLYCOPYRRONIUMINDACATEROL | 1 | Oral | UNK UNK, BID | 0 | BID | |||||||||
| 123528152 | 12352815 | 13 | C | ATORVASTATIN | ATORVASTATIN | 1 | Oral | 10 MG, UNK | 0 | 10 | MG | TABLET | |||||||
| 123528152 | 12352815 | 14 | C | ALPRAZOLAM. | ALPRAZOLAM | 1 | Oral | 0.5 MG, UNK | 0 | .5 | MG | TABLET | |||||||
| 123528152 | 12352815 | 15 | C | BACTRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | UNK | 0 | TABLET | |||||||||
| 123528152 | 12352815 | 16 | C | RAQUIFEROL | 2 | Oral | UNK | 0 | ORAL LIQUID | ||||||||||
| 123528152 | 12352815 | 17 | C | PANTOPRAZOL | PANTOPRAZOLE SODIUM | 1 | Oral | 40 MG, 2/WEEK | 0 | 40 | MG | TABLET | BIW | ||||||
| 123528152 | 12352815 | 18 | C | NEUPOGEN | FILGRASTIM | 1 | Intravenous (not otherwise specified) | 300 ?G, UNK | 0 | 300 | UG | INJECTION | |||||||
| 123528152 | 12352815 | 19 | C | NEUPOGEN | FILGRASTIM | 1 | Subcutaneous | 300 ?G | 0 | 300 | UG | INJECTION | /wk | ||||||
| 123528152 | 12352815 | 20 | C | NEUPOGEN | FILGRASTIM | 1 | Subcutaneous | 300 ?G, UNK | 0 | 300 | UG | INJECTION | |||||||
| 123528152 | 12352815 | 21 | C | NEUPOGEN | FILGRASTIM | 1 | Subcutaneous | 300 ?G, UNK | 0 | 300 | UG | INJECTION | |||||||
| 123528152 | 12352815 | 22 | C | NEUPOGEN | FILGRASTIM | 1 | Subcutaneous | 300 ?G, 1/WEEK | 0 | 300 | UG | INJECTION | /wk | ||||||
| 123528152 | 12352815 | 23 | C | ZOMETA | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | 4 MG, UNK | 0 | 4 | MG | INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123528152 | 12352815 | 1 | Plasma cell myeloma |
| 123528152 | 12352815 | 3 | Plasma cell myeloma |
| 123528152 | 12352815 | 5 | Plasma cell myeloma |
| 123528152 | 12352815 | 7 | Antifungal prophylaxis |
| 123528152 | 12352815 | 8 | Antiviral prophylaxis |
| 123528152 | 12352815 | 9 | Constipation prophylaxis |
| 123528152 | 12352815 | 10 | Pyrexia |
| 123528152 | 12352815 | 11 | Pyrexia |
| 123528152 | 12352815 | 12 | Chronic obstructive pulmonary disease |
| 123528152 | 12352815 | 13 | Dyslipidaemia |
| 123528152 | 12352815 | 14 | Insomnia |
| 123528152 | 12352815 | 15 | Infection prophylaxis |
| 123528152 | 12352815 | 16 | Osteoporosis prophylaxis |
| 123528152 | 12352815 | 17 | Gastritis prophylaxis |
| 123528152 | 12352815 | 18 | Neutropenia |
| 123528152 | 12352815 | 19 | Prophylaxis |
| 123528152 | 12352815 | 23 | Osteoporosis prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123528152 | 12352815 | OT |
| 123528152 | 12352815 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123528152 | 12352815 | Fluid overload | |
| 123528152 | 12352815 | Neutropenia | |
| 123528152 | 12352815 | Pyrexia |
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 |
|---|---|---|---|---|---|---|
| 123528152 | 12352815 | 1 | 20160229 | 20160411 | 0 | |
| 123528152 | 12352815 | 2 | 20160418 | 0 | ||
| 123528152 | 12352815 | 3 | 20160229 | 20160412 | 0 | |
| 123528152 | 12352815 | 4 | 20160419 | 20160420 | 0 | |
| 123528152 | 12352815 | 5 | 20160229 | 20160412 | 0 | |
| 123528152 | 12352815 | 6 | 20160419 | 20160420 | 0 | |
| 123528152 | 12352815 | 7 | 20160229 | 0 | ||
| 123528152 | 12352815 | 8 | 20160229 | 0 | ||
| 123528152 | 12352815 | 9 | 20160314 | 0 | ||
| 123528152 | 12352815 | 10 | 20160413 | 20160415 | 0 | |
| 123528152 | 12352815 | 11 | 20160413 | 20160418 | 0 | |
| 123528152 | 12352815 | 12 | 201509 | 0 | ||
| 123528152 | 12352815 | 13 | 201103 | 0 | ||
| 123528152 | 12352815 | 14 | 201509 | 0 | ||
| 123528152 | 12352815 | 15 | 20160229 | 0 | ||
| 123528152 | 12352815 | 16 | 20160229 | 0 | ||
| 123528152 | 12352815 | 17 | 201509 | 0 | ||
| 123528152 | 12352815 | 18 | 20160416 | 20160416 | 0 | |
| 123528152 | 12352815 | 19 | 20160411 | 0 | ||
| 123528152 | 12352815 | 20 | 20160328 | 0 | ||
| 123528152 | 12352815 | 21 | 20160328 | 0 | ||
| 123528152 | 12352815 | 22 | 20160411 | 0 | ||
| 123528152 | 12352815 | 23 | 20160303 | 0 |