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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1227378111 | 12273781 | 11 | F | 20160308 | 20160815 | 20160415 | 20160819 | EXP | PL-TAKEDA-2016MPI002308 | TAKEDA | 77.00 | YR | F | Y | 87.00000 | KG | 20160819 | MD | PL | PL |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1227378111 | 12273781 | 1 | PS | VELCADE | BORTEZOMIB | 1 | Subcutaneous | 2.6 MG, 1/WEEK | Y | 4371089;V15547-02 | 21602 | 2.6 | MG | INJECTION | /wk | ||||
| 1227378111 | 12273781 | 2 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 90 MG, UNK | Y | 4370217; 4371050 | 0 | 90 | MG | ||||||
| 1227378111 | 12273781 | 3 | SS | MELPHALAN | MELPHALAN | 1 | Oral | 14 MG, UNK | Y | 4371736 | 0 | 14 | MG | ||||||
| 1227378111 | 12273781 | 4 | C | PRESTARIUM /00790701/ | PERINDOPRIL | 1 | Oral | 10 MG, QD | 2510 | MG | 0 | 10 | MG | TABLET | QD | ||||
| 1227378111 | 12273781 | 5 | C | FURSEMIDE | 2 | Oral | 20 MG, QD | 0 | 20 | MG | TABLET | QD | |||||||
| 1227378111 | 12273781 | 6 | C | BETALOC /00376902/ | METOPROLOL TARTRATE | 1 | Oral | 100 MG, QD | 26000 | MG | 0 | 100 | MG | TABLET | QD | ||||
| 1227378111 | 12273781 | 7 | C | BETALOC /00376902/ | METOPROLOL TARTRATE | 1 | Oral | 50 MG, QD | 26000 | MG | 0 | 50 | MG | TABLET | QD | ||||
| 1227378111 | 12273781 | 8 | C | HEVIRAN /00587301/ | 2 | Oral | 400 MG, BID | 36800 | MG | 0 | 400 | MG | TABLET | BID | |||||
| 1227378111 | 12273781 | 9 | C | ZOMETA | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | 4 MG, QD | 8 | MG | 0 | 4 | MG | INJECTION | QD | ||||
| 1227378111 | 12273781 | 10 | C | ZOMETA | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | 4 MG, QD | 8 | MG | 0 | 4 | MG | INJECTION | QD | ||||
| 1227378111 | 12273781 | 11 | C | POLOCARD | ASPIRIN | 1 | Oral | 75 MG, QD | 3450 | MG | 0 | 75 | MG | TABLET | QD | ||||
| 1227378111 | 12273781 | 12 | C | CONTROLOC /01263201/ | 2 | Oral | 20 MG, UNK | 0 | 20 | MG | TABLET | BID | |||||||
| 1227378111 | 12273781 | 13 | C | CONTROLOC /01263201/ | 2 | Oral | 20 MG, UNK | 0 | 20 | MG | TABLET | ||||||||
| 1227378111 | 12273781 | 14 | C | TRAMAL | TRAMADOL | 1 | Oral | 0.15 G, BID | 4.5 | G | 0 | .15 | G | TABLET | BID | ||||
| 1227378111 | 12273781 | 15 | C | KLACID /00984601/ | CLARITHROMYCIN | 1 | Oral | 0.5 G, BID | 4 | G | 0 | .5 | G | TABLET | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1227378111 | 12273781 | 1 | Plasma cell myeloma |
| 1227378111 | 12273781 | 2 | Plasma cell myeloma |
| 1227378111 | 12273781 | 3 | Plasma cell myeloma |
| 1227378111 | 12273781 | 4 | Hypertension |
| 1227378111 | 12273781 | 5 | Cardiac failure |
| 1227378111 | 12273781 | 6 | Cardiac failure |
| 1227378111 | 12273781 | 8 | Prophylaxis |
| 1227378111 | 12273781 | 9 | Osteolysis |
| 1227378111 | 12273781 | 11 | Pulmonary embolism |
| 1227378111 | 12273781 | 12 | Gastrointestinal disorder therapy |
| 1227378111 | 12273781 | 14 | Arthralgia |
| 1227378111 | 12273781 | 15 | Upper respiratory tract infection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1227378111 | 12273781 | HO |
| 1227378111 | 12273781 | OT |
| 1227378111 | 12273781 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1227378111 | 12273781 | Arthralgia | |
| 1227378111 | 12273781 | Decreased appetite | |
| 1227378111 | 12273781 | Dehydration | |
| 1227378111 | 12273781 | Dyspnoea exertional | |
| 1227378111 | 12273781 | Hypotension | |
| 1227378111 | 12273781 | Pharyngitis | |
| 1227378111 | 12273781 | Sudden death | |
| 1227378111 | 12273781 | Thrombocytopenia | |
| 1227378111 | 12273781 | Upper respiratory tract infection |
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 |
|---|---|---|---|---|---|---|
| 1227378111 | 12273781 | 1 | 20160223 | 20160405 | 0 | |
| 1227378111 | 12273781 | 2 | 20160223 | 20160408 | 0 | |
| 1227378111 | 12273781 | 3 | 20160223 | 20160405 | 0 | |
| 1227378111 | 12273781 | 4 | 20150716 | 20160322 | 0 | |
| 1227378111 | 12273781 | 5 | 20150716 | 20160322 | 0 | |
| 1227378111 | 12273781 | 6 | 20150716 | 20160322 | 0 | |
| 1227378111 | 12273781 | 7 | 20160322 | 20160408 | 0 | |
| 1227378111 | 12273781 | 8 | 20160223 | 20160408 | 0 | |
| 1227378111 | 12273781 | 9 | 20160226 | 20160226 | 0 | |
| 1227378111 | 12273781 | 10 | 20160325 | 20160325 | 0 | |
| 1227378111 | 12273781 | 11 | 20160223 | 20160408 | 0 | |
| 1227378111 | 12273781 | 12 | 20160223 | 20160226 | 0 | |
| 1227378111 | 12273781 | 13 | 20160405 | 20160408 | 0 | |
| 1227378111 | 12273781 | 14 | 20160325 | 20160408 | 0 | |
| 1227378111 | 12273781 | 15 | 20160315 | 20160318 | 0 |