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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120917833 | 12091783 | 3 | F | 20151211 | 20160825 | 20160218 | 20160831 | PER | US-CELGENEUS-USA-2016024213 | CELGENE | 76.07 | YR | F | Y | 72.64000 | KG | 20160831 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120917833 | 12091783 | 1 | PS | REVLIMID | LENALIDOMIDE | 1 | Oral | Y | N | A0610A | 21880 | 25 | MG | CAPSULES | |||||
| 120917833 | 12091783 | 2 | SS | REVLIMID | LENALIDOMIDE | 1 | Oral | Y | N | A0610A | 21880 | 25 | MG | CAPSULES | QD | ||||
| 120917833 | 12091783 | 3 | SS | VELCADE | BORTEZOMIB | 1 | Unknown | 20 MILLIGRAM | U | 0 | 3.5 | MG | INJECTION | ||||||
| 120917833 | 12091783 | 4 | SS | VELCADE | BORTEZOMIB | 1 | Unknown | U | 0 | 1.3 | MG/M**2 | UNKNOWN | /wk | ||||||
| 120917833 | 12091783 | 5 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | 0 | 40 | MG | UNKNOWN | ||||||||
| 120917833 | 12091783 | 6 | C | Ranitidine hcl | RANITIDINE HYDROCHLORIDE | 1 | Unknown | 40 MILLIGRAM | 0 | 300 | MG | UNKNOWN | |||||||
| 120917833 | 12091783 | 7 | C | FERROUS SULFATE. | FERROUS SULFATE | 1 | Unknown | 300 MILLIGRAM | 0 | 325 | MG | UNKNOWN | |||||||
| 120917833 | 12091783 | 8 | C | SIMVASTATIN. | SIMVASTATIN | 1 | Unknown | 325 MILLIGRAM | 0 | 20 | MG | UNKNOWN | |||||||
| 120917833 | 12091783 | 9 | C | Aciclovir | ACYCLOVIR | 1 | Unknown | 0 | 400 | MG | INJECTION | BID | |||||||
| 120917833 | 12091783 | 10 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | 400 MILLIGRAM | 0 | 40 | MG | UNKNOWN | /wk | ||||||
| 120917833 | 12091783 | 11 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | 0 | 4 | MG | UNKNOWN | ||||||||
| 120917833 | 12091783 | 12 | C | ASPIRIN. | ASPIRIN | 1 | Oral | 0 | 81 | MG | UNKNOWN | QD | |||||||
| 120917833 | 12091783 | 13 | C | ASPIRIN. | ASPIRIN | 1 | 0 | ||||||||||||
| 120917833 | 12091783 | 14 | C | BACTRIM DS | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 800-160 MG | 0 | UNKNOWN | BID | ||||||||
| 120917833 | 12091783 | 15 | C | BACTRIM DS | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120917833 | 12091783 | 1 | Plasma cell myeloma |
| 120917833 | 12091783 | 3 | Plasma cell myeloma |
| 120917833 | 12091783 | 5 | Gastrooesophageal reflux disease |
| 120917833 | 12091783 | 6 | Gastrooesophageal reflux disease |
| 120917833 | 12091783 | 7 | Vitamin supplementation |
| 120917833 | 12091783 | 8 | Hyperlipidaemia |
| 120917833 | 12091783 | 9 | Antiviral prophylaxis |
| 120917833 | 12091783 | 10 | Adjuvant therapy |
| 120917833 | 12091783 | 11 | Plasma cell myeloma |
| 120917833 | 12091783 | 12 | Cardiac disorder |
| 120917833 | 12091783 | 13 | Thrombosis prophylaxis |
| 120917833 | 12091783 | 14 | Antibiotic prophylaxis |
| 120917833 | 12091783 | 15 | Antifungal prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120917833 | 12091783 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120917833 | 12091783 | Neutrophil count decreased | |
| 120917833 | 12091783 | Pneumonia | |
| 120917833 | 12091783 | White blood cell count decreased |
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 |
|---|---|---|---|---|---|---|
| 120917833 | 12091783 | 1 | 20151120 | 20151230 | 0 | |
| 120917833 | 12091783 | 2 | 20160114 | 0 | ||
| 120917833 | 12091783 | 4 | 20151120 | 0 | ||
| 120917833 | 12091783 | 9 | 20151120 | 0 | ||
| 120917833 | 12091783 | 10 | 20151120 | 20160407 | 0 | |
| 120917833 | 12091783 | 12 | 20151120 | 0 | ||
| 120917833 | 12091783 | 14 | 20151120 | 20160407 | 0 |