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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127105081 | 12710508 | 1 | I | 20160620 | 20160818 | 20160902 | 20160902 | EXP | PHJP2016JP023342 | NOVARTIS | 60.51 | YR | M | Y | 0.00000 | 20160902 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127105081 | 12710508 | 1 | PS | FARYDAK | PANOBINOSTAT | 1 | Oral | 15 MG, QD (6 DAYS, CYCLE-1) | 205353 | 15 | MG | CAPSULE | QD | ||||||
| 127105081 | 12710508 | 2 | SS | FARYDAK | PANOBINOSTAT | 1 | Oral | 10 MG, QD | 205353 | 10 | MG | CAPSULE | QD | ||||||
| 127105081 | 12710508 | 3 | SS | VELCADE | BORTEZOMIB | 1 | Subcutaneous | 1.3 MG/M2, QW | 5 | MG/M2 | 0 | 1.3 | MG/M**2 | INJECTION | /wk | ||||
| 127105081 | 12710508 | 4 | SS | VELCADE | BORTEZOMIB | 1 | Subcutaneous | 1.3 MG/M2, QW | 5 | MG/M2 | 0 | 1.3 | MG/M**2 | INJECTION | /wk | ||||
| 127105081 | 12710508 | 5 | SS | LENADEX | DEXAMETHASONE ACETATE | 1 | Unknown | 0 | |||||||||||
| 127105081 | 12710508 | 6 | C | FEBURIC | FEBUXOSTAT | 1 | Oral | 20 MG, UNK | 0 | 20 | MG | ||||||||
| 127105081 | 12710508 | 7 | C | ACICLOVIR | ACYCLOVIR | 1 | Oral | 200 MG, UNK | 0 | 200 | MG | ||||||||
| 127105081 | 12710508 | 8 | C | FAMOTIDINE. | FAMOTIDINE | 1 | Oral | 20 MG, UNK | 0 | 20 | MG | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127105081 | 12710508 | 1 | Plasma cell myeloma |
| 127105081 | 12710508 | 3 | Plasma cell myeloma |
| 127105081 | 12710508 | 5 | Plasma cell myeloma |
| 127105081 | 12710508 | 6 | Prophylaxis |
| 127105081 | 12710508 | 7 | Prophylaxis |
| 127105081 | 12710508 | 8 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127105081 | 12710508 | DE |
| 127105081 | 12710508 | LT |
| 127105081 | 12710508 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127105081 | 12710508 | Blood creatinine increased | |
| 127105081 | 12710508 | Hypokalaemia | |
| 127105081 | 12710508 | Interstitial lung disease | |
| 127105081 | 12710508 | Malignant neoplasm progression | |
| 127105081 | 12710508 | Nausea | |
| 127105081 | 12710508 | Plasma cell myeloma | |
| 127105081 | 12710508 | Pneumonia | |
| 127105081 | 12710508 | Sepsis | |
| 127105081 | 12710508 | Thrombocytopenia |
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 |
|---|---|---|---|---|---|---|
| 127105081 | 12710508 | 1 | 20160613 | 20160703 | 0 | |
| 127105081 | 12710508 | 2 | 20160704 | 20160708 | 0 | |
| 127105081 | 12710508 | 3 | 20160613 | 20160703 | 0 | |
| 127105081 | 12710508 | 4 | 20160704 | 20160708 | 0 | |
| 127105081 | 12710508 | 5 | 20160613 | 20160708 | 0 | |
| 127105081 | 12710508 | 6 | 20160707 | 0 | ||
| 127105081 | 12710508 | 7 | 20160707 | 0 | ||
| 127105081 | 12710508 | 8 | 20160707 | 0 |