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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120693084 | 12069308 | 4 | F | 2016 | 20160817 | 20160211 | 20160824 | EXP | US-TAKEDA-2016MPI000641 | TAKEDA | 83.02 | YR | F | Y | 0.00000 | 20160824 | OT | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120693084 | 12069308 | 1 | PS | NINLARO | IXAZOMIB | 1 | Oral | 3 MG, 1/WEEK | 208462 | 3 | MG | CAPSULE | /wk | ||||||
| 120693084 | 12069308 | 2 | SS | NINLARO | IXAZOMIB | 1 | Unknown | UNK | 208462 | CAPSULE | |||||||||
| 120693084 | 12069308 | 3 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | UNK | U | 0 | |||||||||
| 120693084 | 12069308 | 4 | SS | REVLIMID | LENALIDOMIDE | 1 | Oral | 10 MG, QD | 55 | MG | 0 | 10 | MG | CAPSULE | QD | ||||
| 120693084 | 12069308 | 5 | SS | REVLIMID | LENALIDOMIDE | 1 | Oral | 5 MG, QD | 55 | MG | 0 | 5 | MG | CAPSULE | QD | ||||
| 120693084 | 12069308 | 6 | SS | REVLIMID | LENALIDOMIDE | 1 | Oral | 5 MG, QD | 55 | MG | 0 | 5 | MG | CAPSULE | QD | ||||
| 120693084 | 12069308 | 7 | C | ALLOPURINOL. | ALLOPURINOL | 1 | Unknown | UNK | U | 0 | |||||||||
| 120693084 | 12069308 | 8 | C | AMLODIPINE BESYLATE. | AMLODIPINE BESYLATE | 1 | Unknown | UNK | U | 0 | |||||||||
| 120693084 | 12069308 | 9 | C | ASPIRIN /00002701/ | ASPIRIN | 1 | Unknown | UNK | U | 0 | |||||||||
| 120693084 | 12069308 | 10 | C | ATENOLOL. | ATENOLOL | 1 | Unknown | UNK | U | 0 | |||||||||
| 120693084 | 12069308 | 11 | C | DOXAZOSIN MESYLATE. | DOXAZOSIN MESYLATE | 1 | Unknown | UNK | U | 0 | |||||||||
| 120693084 | 12069308 | 12 | C | ERGOCALCIFEROL. | ERGOCALCIFEROL | 1 | Unknown | UNK | U | 0 | |||||||||
| 120693084 | 12069308 | 13 | C | HYDROCODONE | HYDROCODONE | 1 | Unknown | U | 0 | ||||||||||
| 120693084 | 12069308 | 14 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Unknown | UNK | U | 0 | |||||||||
| 120693084 | 12069308 | 15 | C | GEMFIBROZIL. | GEMFIBROZIL | 1 | Unknown | UNK | U | 0 | |||||||||
| 120693084 | 12069308 | 16 | C | LOSARTAN POTASSIUM. | LOSARTAN POTASSIUM | 1 | Unknown | UNK | U | 0 | |||||||||
| 120693084 | 12069308 | 17 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | UNK | U | 0 | |||||||||
| 120693084 | 12069308 | 18 | C | OXYCODONE HYDROCHLORIDE. | OXYCODONE HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 120693084 | 12069308 | 19 | C | SIMVASTATIN. | SIMVASTATIN | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120693084 | 12069308 | 1 | Plasma cell myeloma |
| 120693084 | 12069308 | 3 | Plasma cell myeloma |
| 120693084 | 12069308 | 4 | Plasma cell myeloma |
| 120693084 | 12069308 | 8 | Product used for unknown indication |
| 120693084 | 12069308 | 9 | Product used for unknown indication |
| 120693084 | 12069308 | 10 | Product used for unknown indication |
| 120693084 | 12069308 | 11 | Product used for unknown indication |
| 120693084 | 12069308 | 12 | Product used for unknown indication |
| 120693084 | 12069308 | 16 | Product used for unknown indication |
| 120693084 | 12069308 | 19 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120693084 | 12069308 | DS |
| 120693084 | 12069308 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120693084 | 12069308 | Chronic kidney disease | |
| 120693084 | 12069308 | Dehydration | |
| 120693084 | 12069308 | Diarrhoea | |
| 120693084 | 12069308 | Nausea | |
| 120693084 | 12069308 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 120693084 | 12069308 | 1 | 20160115 | 0 | ||
| 120693084 | 12069308 | 2 | 20160125 | 0 | ||
| 120693084 | 12069308 | 3 | 20160125 | 0 | ||
| 120693084 | 12069308 | 4 | 200910 | 0 | ||
| 120693084 | 12069308 | 5 | 201002 | 0 | ||
| 120693084 | 12069308 | 6 | 20160115 | 20160125 | 0 |