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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125053642 | 12505364 | 2 | F | 20160618 | 20160705 | 20160628 | 20160715 | EXP | US-JNJFOC-20160623970 | PHARMACYCLICS | 72.00 | YR | E | M | Y | 0.00000 | 20160715 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125053642 | 12505364 | 1 | SS | IBRUTINIB | IBRUTINIB | 1 | Unknown | Y | N | 0 | CAPSULE | ||||||||
| 125053642 | 12505364 | 2 | SS | IBRUTINIB | IBRUTINIB | 1 | Unknown | Y | N | 0 | CAPSULE | ||||||||
| 125053642 | 12505364 | 3 | SS | IBRUTINIB | IBRUTINIB | 1 | Unknown | Y | N | 0 | CAPSULE | ||||||||
| 125053642 | 12505364 | 4 | PS | IBRUTINIB | IBRUTINIB | 1 | Unknown | Y | N | 205552 | CAPSULE | ||||||||
| 125053642 | 12505364 | 5 | SS | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Intravenous (not otherwise specified) | Y | N | 0 | INTRAVENOUS INFUSION | ||||||||
| 125053642 | 12505364 | 6 | SS | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Intravenous (not otherwise specified) | Y | N | 0 | INTRAVENOUS INFUSION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125053642 | 12505364 | 1 | Chronic lymphocytic leukaemia |
| 125053642 | 12505364 | 2 | Chronic lymphocytic leukaemia |
| 125053642 | 12505364 | 3 | Therapy naive |
| 125053642 | 12505364 | 4 | Therapy naive |
| 125053642 | 12505364 | 5 | Chronic lymphocytic leukaemia |
| 125053642 | 12505364 | 6 | Therapy naive |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125053642 | 12505364 | OT |
| 125053642 | 12505364 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125053642 | 12505364 | Acute kidney injury | |
| 125053642 | 12505364 | Dehydration | |
| 125053642 | 12505364 | Haemoglobin decreased | |
| 125053642 | 12505364 | Hyperbilirubinaemia | |
| 125053642 | 12505364 | 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 |
|---|---|---|---|---|---|---|
| 125053642 | 12505364 | 1 | 20160130 | 20160618 | 0 | |
| 125053642 | 12505364 | 2 | 20160624 | 0 | ||
| 125053642 | 12505364 | 3 | 20160130 | 20160618 | 0 | |
| 125053642 | 12505364 | 4 | 20160624 | 0 | ||
| 125053642 | 12505364 | 5 | 20160130 | 20160618 | 0 | |
| 125053642 | 12505364 | 6 | 20160130 | 20160618 | 0 |