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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125285492 | 12528549 | 2 | F | 20150203 | 20160726 | 20160705 | 20160805 | EXP | ES-CELGENEUS-ESP-2015071036 | CELGENE | 78.47 | YR | M | Y | 0.00000 | 20160805 | OT | ES | ES |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125285492 | 12528549 | 1 | PS | REVLIMID | LENALIDOMIDE | 1 | Oral | U | 21880 | 25 | MG | CAPSULES | |||||||
| 125285492 | 12528549 | 2 | SS | REVLIMID | LENALIDOMIDE | 1 | Oral | U | 21880 | 25 | MG | CAPSULES | |||||||
| 125285492 | 12528549 | 3 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | U | 0 | 20 | MG | UNKNOWN | |||||||
| 125285492 | 12528549 | 4 | SS | Daratumumab | DARATUMUMAB | 1 | Oral | U | U | 0 | 16 | MG/KG | UNKNOWN | ||||||
| 125285492 | 12528549 | 5 | C | neorrecormon | 2 | Unknown | 0 | 10000 | IU | UNKNOWN | |||||||||
| 125285492 | 12528549 | 6 | C | neorrecormon | 2 | Unknown | 0 | 30000 | IU | UNKNOWN | |||||||||
| 125285492 | 12528549 | 7 | C | neorrecormon | 2 | Unknown | 0 | 10000 | IU | UNKNOWN | |||||||||
| 125285492 | 12528549 | 8 | C | neorrecormon | 2 | Unknown | 0 | 30000 | IU | UNKNOWN | |||||||||
| 125285492 | 12528549 | 9 | C | neorrecormon | 2 | Unknown | 30000 UI (WEDNESDAY) + 10000 UI (SUNDAY) | 0 | UNKNOWN | ||||||||||
| 125285492 | 12528549 | 10 | C | nivestim | FILGRASTIM | 1 | Unknown | 0 | UNKNOWN | QD | |||||||||
| 125285492 | 12528549 | 11 | C | phosphate sandoz forte | 2 | Unknown | 0 | UNKNOWN | BID | ||||||||||
| 125285492 | 12528549 | 12 | C | phosphate sandoz forte | 2 | Unknown | 0 | UNKNOWN | TID | ||||||||||
| 125285492 | 12528549 | 13 | C | phosphate sandoz forte | 2 | Unknown | 0 | UNKNOWN | Q12H | ||||||||||
| 125285492 | 12528549 | 14 | C | phosphate sandoz forte | 2 | Unknown | 0 | UNKNOWN | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125285492 | 12528549 | 1 | Plasma cell myeloma recurrent |
| 125285492 | 12528549 | 3 | Plasma cell myeloma recurrent |
| 125285492 | 12528549 | 4 | Plasma cell myeloma recurrent |
| 125285492 | 12528549 | 5 | Product used for unknown indication |
| 125285492 | 12528549 | 10 | Product used for unknown indication |
| 125285492 | 12528549 | 11 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125285492 | 12528549 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125285492 | 12528549 | Anaemia | |
| 125285492 | 12528549 | Electrocardiogram QT prolonged | |
| 125285492 | 12528549 | Hypophosphataemia | |
| 125285492 | 12528549 | Neutropenia | |
| 125285492 | 12528549 | Platelet count decreased | |
| 125285492 | 12528549 | Rash |
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 |
|---|---|---|---|---|---|---|
| 125285492 | 12528549 | 1 | 20150621 | 0 | ||
| 125285492 | 12528549 | 5 | 20150427 | 20150629 | 0 | |
| 125285492 | 12528549 | 6 | 20150629 | 20150831 | 0 | |
| 125285492 | 12528549 | 7 | 20150831 | 20160523 | 0 | |
| 125285492 | 12528549 | 8 | 20160523 | 20160620 | 0 | |
| 125285492 | 12528549 | 9 | 20160620 | 0 | ||
| 125285492 | 12528549 | 10 | 20150706 | 20160718 | 0 | |
| 125285492 | 12528549 | 11 | 20151026 | 20160620 | 0 | |
| 125285492 | 12528549 | 12 | 20160621 | 0 | ||
| 125285492 | 12528549 | 13 | 20150507 | 20150511 | 0 | |
| 125285492 | 12528549 | 14 | 20150512 | 20151026 | 0 |