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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120913474 | 12091347 | 4 | F | 201511 | 20160614 | 20160218 | 20160725 | EXP | FR-TAKEDA-2016MPI001041 | TAKEDA | 62.00 | YR | F | Y | 40.00000 | KG | 20160725 | OT | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120913474 | 12091347 | 1 | PS | VELCADE | BORTEZOMIB | 1 | Subcutaneous | 1.7 MG, UNK | 21602 | 1.7 | MG | INJECTION | |||||||
| 120913474 | 12091347 | 2 | SS | VELCADE | BORTEZOMIB | 1 | Subcutaneous | UNK | 21602 | INJECTION | |||||||||
| 120913474 | 12091347 | 3 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Intravenous (not otherwise specified) | UNK | 0 | ||||||||||
| 120913474 | 12091347 | 4 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Intravenous (not otherwise specified) | 40 MG, UNK | 0 | 40 | MG | ||||||||
| 120913474 | 12091347 | 5 | SS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | 170 MG, UNK | 0 | 170 | MG | ||||||||
| 120913474 | 12091347 | 6 | SS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | UNK | 0 | ||||||||||
| 120913474 | 12091347 | 7 | SS | LEVACT | BENDAMUSTINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 120 MG, UNK | 0 | 120 | MG | ||||||||
| 120913474 | 12091347 | 8 | SS | LEVACT | BENDAMUSTINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | UNK | 0 | ||||||||||
| 120913474 | 12091347 | 9 | C | POLARAMINE | DEXCHLORPHENIRAMINE MALEATE | 1 | Intravenous (not otherwise specified) | 5 MG, UNK | 0 | 5 | MG | SOLUTION FOR INJECTION | |||||||
| 120913474 | 12091347 | 10 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Intravenous (not otherwise specified) | 500 MG, UNK | 0 | 500 | MG | ||||||||
| 120913474 | 12091347 | 11 | C | ONDANSETRON | ONDANSETRON | 1 | Intravenous (not otherwise specified) | 8 MG, UNK | 0 | 8 | MG | SOLUTION FOR INJECTION | |||||||
| 120913474 | 12091347 | 12 | C | EMEND | APREPITANT | 1 | Oral | 125 MG, UNK | 0 | 125 | MG | ||||||||
| 120913474 | 12091347 | 13 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 60 MG, UNK | 0 | 60 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120913474 | 12091347 | 1 | Mantle cell lymphoma stage IV |
| 120913474 | 12091347 | 3 | Mantle cell lymphoma |
| 120913474 | 12091347 | 5 | Mantle cell lymphoma stage IV |
| 120913474 | 12091347 | 7 | Mantle cell lymphoma |
| 120913474 | 12091347 | 9 | Hypersensitivity |
| 120913474 | 12091347 | 10 | Pain |
| 120913474 | 12091347 | 11 | Prophylaxis of nausea and vomiting |
| 120913474 | 12091347 | 12 | Prophylaxis of nausea and vomiting |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120913474 | 12091347 | OT |
| 120913474 | 12091347 | DE |
| 120913474 | 12091347 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120913474 | 12091347 | Febrile bone marrow aplasia | |
| 120913474 | 12091347 | Mantle cell lymphoma | |
| 120913474 | 12091347 | Nausea | |
| 120913474 | 12091347 | Off label use |
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 |
|---|---|---|---|---|---|---|
| 120913474 | 12091347 | 1 | 20151110 | 20151121 | 0 | |
| 120913474 | 12091347 | 2 | 20151218 | 0 | ||
| 120913474 | 12091347 | 4 | 20151110 | 20151111 | 0 | |
| 120913474 | 12091347 | 5 | 20151110 | 20151111 | 0 | |
| 120913474 | 12091347 | 6 | 20151218 | 0 | ||
| 120913474 | 12091347 | 7 | 20151111 | 20151112 | 0 | |
| 120913474 | 12091347 | 9 | 20151110 | 20151111 | 0 | |
| 120913474 | 12091347 | 10 | 20151110 | 20151111 | 0 | |
| 120913474 | 12091347 | 11 | 20151110 | 20151111 | 0 | |
| 120913474 | 12091347 | 12 | 20151110 | 20151113 | 0 | |
| 120913474 | 12091347 | 13 | 20151110 | 20151111 | 0 |