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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125663694 | 12566369 | 4 | F | 201607 | 20160729 | 20160718 | 20160810 | EXP | US-JNJFOC-20160709862 | PHARMACYCLICS | 71.03 | YR | E | M | Y | 0.00000 | 20160810 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125663694 | 12566369 | 1 | PS | IMBRUVICA | IBRUTINIB | 1 | Oral | U | U | L0503309A1 | 205552 | 420 | MG | CAPSULE | QD | ||||
| 125663694 | 12566369 | 2 | SS | ALLOPURINOL. | ALLOPURINOL | 1 | Y | 0 | |||||||||||
| 125663694 | 12566369 | 3 | SS | PREDNISONE. | PREDNISONE | 1 | U | 0 | |||||||||||
| 125663694 | 12566369 | 4 | SS | ASPIRIN. | ASPIRIN | 1 | UNK UNK, QD | U | 0 | ||||||||||
| 125663694 | 12566369 | 5 | C | SIMVASTATIN. | SIMVASTATIN | 1 | 0 | UNSPECIFIED | |||||||||||
| 125663694 | 12566369 | 6 | C | LISINOPRIL. | LISINOPRIL | 1 | 0 | ||||||||||||
| 125663694 | 12566369 | 7 | C | ULORIC | FEBUXOSTAT | 1 | 0 | ||||||||||||
| 125663694 | 12566369 | 8 | C | BACLOFEN. | BACLOFEN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125663694 | 12566369 | 1 | Chronic lymphocytic leukaemia |
| 125663694 | 12566369 | 2 | Product used for unknown indication |
| 125663694 | 12566369 | 3 | Product used for unknown indication |
| 125663694 | 12566369 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125663694 | 12566369 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125663694 | 12566369 | Blood urine present | |
| 125663694 | 12566369 | Contusion | |
| 125663694 | 12566369 | Dry skin | |
| 125663694 | 12566369 | Dysphonia | |
| 125663694 | 12566369 | Gastrooesophageal reflux disease | |
| 125663694 | 12566369 | Insomnia | |
| 125663694 | 12566369 | Muscle spasms | |
| 125663694 | 12566369 | Nasal congestion | |
| 125663694 | 12566369 | Pyrexia | |
| 125663694 | 12566369 | Rash | |
| 125663694 | 12566369 | Skin exfoliation | |
| 125663694 | 12566369 | Skin fissures | |
| 125663694 | 12566369 | Stomatitis | |
| 125663694 | 12566369 | Urticaria | |
| 125663694 | 12566369 | White blood cell disorder |
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 |
|---|---|---|---|---|---|---|
| 125663694 | 12566369 | 1 | 20160701 | 0 | ||
| 125663694 | 12566369 | 4 | 20160707 | 0 |