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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 103470452 | 10347045 | 2 | F | 20160712 | 20140729 | 20160725 | EXP | GB-JNJFOC-20140710494 | JANSSEN | COOK G, WILLIAMS C, BROWN JM, CAIRNS DA, CAVENAGH J, SNOWDEN JA, ET AL. HIGH-DOSE CHEMOTHERAPY PLUS AUTOLOGOUS STEM-CELL TRANSPLANTATION AS CONSOLIDATION THERAPY IN PATIENTS WITH RELAPSED MULTIPLE MYELOMA AFTER PREVIOUS AUTOLOGOUS STEM-CELL TRANSPLANTATION (NCRI MYELOMA XRELAPSE [INTENSIVE TRIAL]): A RANDOMISED, OPEN-LAB. THE LANCET ONCOLOGY JUL-2014;15 (8):874-885. COOK G, ASHCROFT AJ, CAIRNS DA, WILLIAMS CD, BROWN JM, CAVENAGH JD, ET AL. THE EFFECT OF SALVAGE AUTOLOGOUS STEM-CELL TRANSPLANTAT | 0.00 | Y | 0.00000 | 20160725 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 103470452 | 10347045 | 1 | PS | DOXORUBICIN | DOXORUBICIN | 1 | Intravenous (not otherwise specified) | ON DAYS 1 TO 4 | U | 50718 | 9 | MG/M**2 | LIPOSOME INJECTION | ||||||
| 103470452 | 10347045 | 2 | SS | BORTEZOMIB | BORTEZOMIB | 1 | Intravenous (not otherwise specified) | ON DAYS 1, 4, 8 AND 11 | 0 | 1.3 | MG/M**2 | UNSPECIFIED | |||||||
| 103470452 | 10347045 | 3 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | ON DAYS 1 TO 4, 8 TO 11 AND 15 TO 18 DURING CYCLE 1 AND DAYS 1 TO 4 DURING CYCLES 2 TO 4 | 0 | 40 | MG | UNSPECIFIED | |||||||
| 103470452 | 10347045 | 4 | C | GRANULOCYTE COLONY-STIMULATING FACTOR | GRANULOCYTE COLONY-STIMULATING FACTOR NOS | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 103470452 | 10347045 | 1 | Plasma cell myeloma |
| 103470452 | 10347045 | 2 | Plasma cell myeloma |
| 103470452 | 10347045 | 3 | Plasma cell myeloma |
| 103470452 | 10347045 | 4 | Palliative care |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 103470452 | 10347045 | DE |
| 103470452 | 10347045 | OT |
| 103470452 | 10347045 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 103470452 | 10347045 | Anaemia | |
| 103470452 | 10347045 | Cerebrovascular accident | |
| 103470452 | 10347045 | Death | |
| 103470452 | 10347045 | Diarrhoea | |
| 103470452 | 10347045 | Infection | |
| 103470452 | 10347045 | Nausea | |
| 103470452 | 10347045 | Neutropenia | |
| 103470452 | 10347045 | Peripheral motor neuropathy | |
| 103470452 | 10347045 | Peripheral sensory neuropathy | |
| 103470452 | 10347045 | Respiratory tract infection | |
| 103470452 | 10347045 | Thrombocytopenia | |
| 103470452 | 10347045 | Vomiting |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |