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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126931851 | 12693185 | 1 | I | 20160816 | 20160829 | 20160829 | EXP | FR-GLENMARK PHARMACEUTICALS INC, USA.-2016GMK024075 | GLENMARK | JOLIVOT P A, POINSIGNON V, PACI A, GUIDET B, PICHEREAU C, FERNANDEZ C, HINDLET P.. A CASE OF MELPHALAN SUSTAINED ACCUMULATION IN AN 80-YEAR OLD PATIENT.. INTERNATIONAL JOURNAL OF CLINICAL PHARMACY.. 2015;37(6):984-987 | 0.00 | Y | 0.00000 | 20160829 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126931851 | 12693185 | 1 | PS | SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Unknown | 160/800 MG, THREE TIMES A WEEK | Y | 0 | |||||||||
| 126931851 | 12693185 | 2 | I | SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Y | 0 | |||||||||||
| 126931851 | 12693185 | 3 | I | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | 20 MG, QD | Y | 0 | 20 | MG | |||||||
| 126931851 | 12693185 | 4 | I | MELPHALAN | MELPHALAN | 1 | Unknown | 9 MG/M2 (16 MG), FROM DAY 1 TO 4, QD | Y | 0 | 9 | MG/M**2 | |||||||
| 126931851 | 12693185 | 5 | I | CANDESARTAN | CANDESARTAN | 1 | Unknown | UNK | Y | 0 | |||||||||
| 126931851 | 12693185 | 6 | I | ATORVASTATIN | ATORVASTATIN | 1 | Unknown | UNK | Y | 0 | |||||||||
| 126931851 | 12693185 | 7 | SS | BORTEZOMIB | BORTEZOMIB | 1 | Subcutaneous | 1.3 MG/M2, ON DAYS 1, 4, 8 AND 11 | Y | 0 | 1.3 | MG/M**2 | INJECTION | ||||||
| 126931851 | 12693185 | 8 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 60 MG/M2, UNK | 0 | 60 | MG/M**2 | ||||||||
| 126931851 | 12693185 | 9 | C | PREDNISONE. | PREDNISONE | 1 | 0 | ||||||||||||
| 126931851 | 12693185 | 10 | C | SOTALOL. | SOTALOL | 1 | Unknown | UNK | 0 | ||||||||||
| 126931851 | 12693185 | 11 | I | VALACICLOVIR | VALACYCLOVIR HYDROCHLORIDE | 1 | Unknown | 500 MG, QD | 0 | 500 | MG | ||||||||
| 126931851 | 12693185 | 12 | C | CALCIUM FOLINATE | LEUCOVORIN CALCIUM | 1 | Unknown | 25 MG, QW | 0 | 25 | MG | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126931851 | 12693185 | 1 | Prophylaxis |
| 126931851 | 12693185 | 2 | Prophylaxis |
| 126931851 | 12693185 | 3 | Prophylaxis |
| 126931851 | 12693185 | 4 | Plasma cell myeloma |
| 126931851 | 12693185 | 5 | Product used for unknown indication |
| 126931851 | 12693185 | 6 | Hypercholesterolaemia |
| 126931851 | 12693185 | 7 | Plasma cell myeloma |
| 126931851 | 12693185 | 8 | Plasma cell myeloma |
| 126931851 | 12693185 | 9 | Plasma cell myeloma |
| 126931851 | 12693185 | 10 | Hypertension |
| 126931851 | 12693185 | 11 | Prophylaxis |
| 126931851 | 12693185 | 12 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126931851 | 12693185 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126931851 | 12693185 | Acute kidney injury | |
| 126931851 | 12693185 | Candida infection | |
| 126931851 | 12693185 | Diarrhoea | |
| 126931851 | 12693185 | Drug interaction | |
| 126931851 | 12693185 | Escherichia infection | |
| 126931851 | 12693185 | Hyperkalaemia | |
| 126931851 | 12693185 | Hypersensitivity | |
| 126931851 | 12693185 | Hyponatraemia | |
| 126931851 | 12693185 | Hypotension | |
| 126931851 | 12693185 | Muscular weakness | |
| 126931851 | 12693185 | Oliguria | |
| 126931851 | 12693185 | Pancytopenia | |
| 126931851 | 12693185 | Polyneuropathy | |
| 126931851 | 12693185 | Product use issue | |
| 126931851 | 12693185 | Pyrexia | |
| 126931851 | 12693185 | Septic shock | |
| 126931851 | 12693185 | Skin discolouration | |
| 126931851 | 12693185 | Toxicity to various agents | |
| 126931851 | 12693185 | 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 |
|---|---|---|---|---|---|---|
| 126931851 | 12693185 | 4 | 20140401 | 0 |