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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125451331 | 12545133 | 1 | I | 20160314 | 20160408 | 20160711 | 20160711 | EXP | CA-JNJFOC-20160410890 | PHARMACYCLICS | 69.00 | YR | E | M | Y | 0.00000 | 20160711 | MD | CA | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125451331 | 12545133 | 1 | SS | IBRUTINIB | IBRUTINIB | 1 | Oral | CYCLE 2+ , 420 MG, QD, DAYS, 1-28 | 14700 | MG | Y | N | 0 | 420 | MG | CAPSULE | QD | ||
| 125451331 | 12545133 | 2 | PS | IBRUTINIB | IBRUTINIB | 1 | Oral | CYCLE 1, 420 MG, QD, DAYS 2-28 | 14700 | MG | Y | N | 205552 | 420 | MG | CAPSULE | QD | ||
| 125451331 | 12545133 | 3 | SS | LENALIDOMIDE | LENALIDOMIDE | 1 | Oral | ALL CYCLES, 10 MG, QD, DAYS 1-21 | 360 | MG | Y | N | 0 | 10 | MG | CAPSULE | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125451331 | 12545133 | 1 | Diffuse large B-cell lymphoma |
| 125451331 | 12545133 | 2 | Diffuse large B-cell lymphoma |
| 125451331 | 12545133 | 3 | Diffuse large B-cell lymphoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125451331 | 12545133 | OT |
| 125451331 | 12545133 | DE |
| 125451331 | 12545133 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125451331 | 12545133 | Anaemia | |
| 125451331 | 12545133 | Hyperkalaemia | |
| 125451331 | 12545133 | Hyponatraemia | |
| 125451331 | 12545133 | International normalised ratio increased | |
| 125451331 | 12545133 | Platelet count decreased | |
| 125451331 | 12545133 | Sepsis |
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 |
|---|---|---|---|---|---|---|
| 125451331 | 12545133 | 2 | 20160209 | 20160315 | 0 | |
| 125451331 | 12545133 | 3 | 20160208 | 20160315 | 0 |