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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123253046 | 12325304 | 6 | F | 20150901 | 20160815 | 20160502 | 20160819 | EXP | GB-TAKEDA-2016MPI003559 | TAKEDA | 87.00 | YR | M | Y | 82.00000 | KG | 20160819 | OT | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123253046 | 12325304 | 1 | PS | VELCADE | BORTEZOMIB | 1 | Subcutaneous | 1.8 MG, UNK | Y | Z1501508 | 21602 | 1.8 | MG | INJECTION | |||||
| 123253046 | 12325304 | 2 | SS | VELCADE | BORTEZOMIB | 1 | Subcutaneous | 1.8 MG, UNK | Y | Z1501508 | 21602 | 1.8 | MG | INJECTION | |||||
| 123253046 | 12325304 | 3 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 10 MG, UNK | Y | MQ0401001 | 0 | 10 | MG | TABLET | |||||
| 123253046 | 12325304 | 4 | SS | DARATUMUMAB | DARATUMUMAB | 1 | Intravenous (not otherwise specified) | 1100 MG, 3/WEEK | Y | MQ0401001 | 0 | 1100 | MG | TIW | |||||
| 123253046 | 12325304 | 5 | SS | MELPHALAN | MELPHALAN | 1 | Oral | 10 MG, UNK | Y | 0 | 10 | MG | |||||||
| 123253046 | 12325304 | 6 | C | FILGRASTIM | FILGRASTIM | 1 | Subcutaneous | 300 ?G, UNK | 0 | 300 | UG | INJECTION | |||||||
| 123253046 | 12325304 | 7 | C | FILGRASTIM | FILGRASTIM | 1 | Subcutaneous | 300 ?G, UNK | 0 | 300 | UG | INJECTION | |||||||
| 123253046 | 12325304 | 8 | C | CIPROFLOXACIN. | CIPROFLOXACIN | 1 | Oral | 500 MG, BID | 5000 | MG | 0 | 500 | MG | CAPSULE | BID | ||||
| 123253046 | 12325304 | 9 | C | COTRIMOXAZOLE | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 480 MG, UNK | 0 | 480 | MG | CAPSULE | |||||||
| 123253046 | 12325304 | 10 | C | COTRIMOXAZOLE | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 480 MG, UNK | 0 | 480 | MG | CAPSULE | |||||||
| 123253046 | 12325304 | 11 | C | ACICLOVIR | ACYCLOVIR | 1 | Oral | 400 MG, BID | 0 | 400 | MG | CAPSULE | BID | ||||||
| 123253046 | 12325304 | 12 | C | CALCICHEW | CALCIUM CARBONATE | 1 | Oral | 2.25 G, UNK | 0 | 2.25 | G | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123253046 | 12325304 | 1 | Plasma cell myeloma |
| 123253046 | 12325304 | 3 | Plasma cell myeloma |
| 123253046 | 12325304 | 4 | Plasma cell myeloma |
| 123253046 | 12325304 | 5 | Plasma cell myeloma |
| 123253046 | 12325304 | 6 | Prophylaxis |
| 123253046 | 12325304 | 8 | Infection prophylaxis |
| 123253046 | 12325304 | 9 | Infection prophylaxis |
| 123253046 | 12325304 | 11 | Infection prophylaxis |
| 123253046 | 12325304 | 12 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123253046 | 12325304 | HO |
| 123253046 | 12325304 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123253046 | 12325304 | Anaemia | |
| 123253046 | 12325304 | Ear infection | |
| 123253046 | 12325304 | Hypoproteinaemia | |
| 123253046 | 12325304 | Infection | |
| 123253046 | 12325304 | Neutropenia | |
| 123253046 | 12325304 | 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 |
|---|---|---|---|---|---|---|
| 123253046 | 12325304 | 1 | 20150817 | 20160411 | 0 | |
| 123253046 | 12325304 | 2 | 20160503 | 0 | ||
| 123253046 | 12325304 | 3 | 20150817 | 20160317 | 0 | |
| 123253046 | 12325304 | 4 | 20150817 | 20160404 | 0 | |
| 123253046 | 12325304 | 5 | 20150817 | 20160317 | 0 | |
| 123253046 | 12325304 | 6 | 20160223 | 20160225 | 0 | |
| 123253046 | 12325304 | 7 | 20150908 | 20150909 | 0 | |
| 123253046 | 12325304 | 8 | 20150910 | 20150914 | 0 | |
| 123253046 | 12325304 | 9 | 20150910 | 0 | ||
| 123253046 | 12325304 | 10 | 20160118 | 0 | ||
| 123253046 | 12325304 | 11 | 20160118 | 0 | ||
| 123253046 | 12325304 | 12 | 20160201 | 0 |