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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 835421610 | 8354216 | 10 | F | 201110 | 20160805 | 20120125 | 20160809 | EXP | PHHY2011CA95178 | NOVARTIS | 73.66 | YR | F | Y | 0.00000 | 20160810 | CN | COUNTRY NOT SPECIFIED | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 835421610 | 8354216 | 1 | PS | EXJADE | DEFERASIROX | 1 | Oral | 500 MG, QD | 21882 | 500 | MG | DISPERSIBLE TABLET | QD | ||||||
| 835421610 | 8354216 | 2 | SS | EXJADE | DEFERASIROX | 1 | Oral | 1000 MG, QD | 21882 | 1000 | MG | DISPERSIBLE TABLET | QD | ||||||
| 835421610 | 8354216 | 3 | SS | EXJADE | DEFERASIROX | 1 | Oral | 1000 MG, QD | 21882 | 1000 | MG | DISPERSIBLE TABLET | QD | ||||||
| 835421610 | 8354216 | 4 | C | MULTIVITAMINS | VITAMINS | 1 | Unknown | UNK | U | 0 | |||||||||
| 835421610 | 8354216 | 5 | C | FOSAVANCE | ALENDRONATE SODIUMCHOLECALCIFEROL | 1 | Unknown | UNK | U | 0 | |||||||||
| 835421610 | 8354216 | 6 | C | ENSURE | AMINO ACIDSDEXTROSEELECTROLYTES NOSSOYBEAN OILVITAMINS | 1 | Unknown | UNK | U | 0 | |||||||||
| 835421610 | 8354216 | 7 | C | BOOST | DIETARY SUPPLEMENT | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 835421610 | 8354216 | 1 | Myelodysplastic syndrome |
| 835421610 | 8354216 | 4 | Product used for unknown indication |
| 835421610 | 8354216 | 5 | Product used for unknown indication |
| 835421610 | 8354216 | 6 | Product used for unknown indication |
| 835421610 | 8354216 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 835421610 | 8354216 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 835421610 | 8354216 | Back pain | |
| 835421610 | 8354216 | Blood calcium increased | |
| 835421610 | 8354216 | Blood iron increased | |
| 835421610 | 8354216 | Blood pressure decreased | |
| 835421610 | 8354216 | Dyspnoea | |
| 835421610 | 8354216 | Influenza | |
| 835421610 | 8354216 | Malaise | |
| 835421610 | 8354216 | Micturition frequency decreased | |
| 835421610 | 8354216 | Pericarditis | |
| 835421610 | 8354216 | Peripheral swelling | |
| 835421610 | 8354216 | Protein urine present | |
| 835421610 | 8354216 | Pulmonary oedema | |
| 835421610 | 8354216 | Renal disorder | |
| 835421610 | 8354216 | Serum ferritin increased | |
| 835421610 | 8354216 | Thirst decreased | |
| 835421610 | 8354216 | Urine abnormality | |
| 835421610 | 8354216 | Urine output 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 |
|---|---|---|---|---|---|---|
| 835421610 | 8354216 | 1 | 20110701 | 0 | ||
| 835421610 | 8354216 | 2 | 201107 | 0 |