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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127354661 | 12735466 | 1 | I | 2014 | 20160829 | 20160912 | 20160912 | EXP | US-JNJFOC-20160907284 | PHARMACYCLICS | 75.27 | YR | E | M | Y | 0.00000 | 20160912 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127354661 | 12735466 | 1 | SS | IMBRUVICA | IBRUTINIB | 1 | Unknown | Y | N | 0 | CAPSULE | ||||||||
| 127354661 | 12735466 | 2 | PS | IMBRUVICA | IBRUTINIB | 1 | Unknown | Y | N | 205552 | CAPSULE | ||||||||
| 127354661 | 12735466 | 3 | SS | WARFARIN | WARFARIN | 1 | 0 | 2.5 | MG | TABLET | |||||||||
| 127354661 | 12735466 | 4 | C | ACYCLOVIR. | ACYCLOVIR | 1 | 0 | 400 | MG | TABLET | |||||||||
| 127354661 | 12735466 | 5 | C | ALBUTEROL SULFATE. | ALBUTEROL SULFATE | 1 | 0 | ||||||||||||
| 127354661 | 12735466 | 6 | C | BUDESONIDE. | BUDESONIDE | 1 | 0 | NASAL SPRAY | |||||||||||
| 127354661 | 12735466 | 7 | C | CLOBETASOL | CLOBETASOL | 1 | 0 | ||||||||||||
| 127354661 | 12735466 | 8 | C | HYDROCHLOROTHIAZIDE. | HYDROCHLOROTHIAZIDE | 1 | 0 | 25 | MG | TABLET | |||||||||
| 127354661 | 12735466 | 9 | C | IRON | IRON | 1 | 0 | 325 | MG | TABLET | |||||||||
| 127354661 | 12735466 | 10 | C | METOPROLOL SUCCINATE. | METOPROLOL SUCCINATE | 1 | 0 | 50 | MG | TABLET | |||||||||
| 127354661 | 12735466 | 11 | C | PERCOCET | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | 5 MG-325 MG | 0 | |||||||||||
| 127354661 | 12735466 | 12 | C | PERFOROMIST | FORMOTEROL FUMARATE DIHYDRATE | 1 | 20MCG/2ML | 0 | |||||||||||
| 127354661 | 12735466 | 13 | C | PROAIR HFA | ALBUTEROL SULFATE | 1 | 0 | AEROSOLS | |||||||||||
| 127354661 | 12735466 | 14 | C | SIMVASTATIN. | SIMVASTATIN | 1 | 0 | 10 | MG | TABLET | |||||||||
| 127354661 | 12735466 | 15 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | 0 | 50 | MG | TABLET | |||||||||
| 127354661 | 12735466 | 16 | C | VALIUM | DIAZEPAM | 1 | 0 | 10 | MG | TABLET | |||||||||
| 127354661 | 12735466 | 17 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | 0 | 500 | UG | TABLET | |||||||||
| 127354661 | 12735466 | 18 | C | VITAMIN B-6 | PYRIDOXINE | 1 | 0 | 100 | MG | TABLET | |||||||||
| 127354661 | 12735466 | 19 | C | IMMUNOGLOBULIN HUMAN NORMAL | HUMAN IMMUNOGLOBULIN G | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127354661 | 12735466 | 1 | Chronic lymphocytic leukaemia |
| 127354661 | 12735466 | 2 | Chronic lymphocytic leukaemia |
| 127354661 | 12735466 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127354661 | 12735466 | OT |
| 127354661 | 12735466 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127354661 | 12735466 | Anxiety | |
| 127354661 | 12735466 | Depression | |
| 127354661 | 12735466 | Disease progression | |
| 127354661 | 12735466 | Family stress | |
| 127354661 | 12735466 | Fatigue | |
| 127354661 | 12735466 | Heart rate irregular | |
| 127354661 | 12735466 | Hot flush | |
| 127354661 | 12735466 | Insomnia | |
| 127354661 | 12735466 | Meningioma | |
| 127354661 | 12735466 | Purpura senile | |
| 127354661 | 12735466 | Rash | |
| 127354661 | 12735466 | Seizure | |
| 127354661 | 12735466 | Subdural haematoma | |
| 127354661 | 12735466 | White blood cell count increased |
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 |
|---|---|---|---|---|---|---|
| 127354661 | 12735466 | 1 | 201406 | 201407 | 0 | |
| 127354661 | 12735466 | 2 | 201410 | 201411 | 0 |