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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124937104 | 12493710 | 4 | F | 20160607 | 20160830 | 20160623 | 20160912 | EXP | US-JNJFOC-20160620272 | PHARMACYCLICS | 77.60 | YR | E | M | Y | 0.00000 | 20160912 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124937104 | 12493710 | 1 | PS | IMBRUVICA | IBRUTINIB | 1 | Oral | 35280 | MG | Y | N | L0503308A1 | 205552 | 420 | MG | CAPSULE | QD | ||
| 124937104 | 12493710 | 2 | SS | COUMADIN | WARFARIN SODIUM | 1 | 0 | ||||||||||||
| 124937104 | 12493710 | 3 | C | SIMVASTATIN. | SIMVASTATIN | 1 | 0 | UNSPECIFIED | |||||||||||
| 124937104 | 12493710 | 4 | C | ACYCLOVIR. | ACYCLOVIR | 1 | 0 | ||||||||||||
| 124937104 | 12493710 | 5 | C | MIRALAX | POLYETHYLENE GLYCOL 3350 | 1 | 0 | ||||||||||||
| 124937104 | 12493710 | 6 | C | ESCITALOPRAM OXALATE. | ESCITALOPRAM OXALATE | 1 | 0 | ||||||||||||
| 124937104 | 12493710 | 7 | C | FLECAINIDE ACETATE. | FLECAINIDE ACETATE | 1 | 0 | ||||||||||||
| 124937104 | 12493710 | 8 | C | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | 0 | ||||||||||||
| 124937104 | 12493710 | 9 | C | ASPIRINA ADULTOS | 2 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124937104 | 12493710 | 1 | Waldenstrom's macroglobulinaemia |
| 124937104 | 12493710 | 2 | Atrial fibrillation |
| 124937104 | 12493710 | 3 | Atrial fibrillation |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124937104 | 12493710 | OT |
| 124937104 | 12493710 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124937104 | 12493710 | Contusion | |
| 124937104 | 12493710 | Fall | |
| 124937104 | 12493710 | Haemorrhage subcutaneous | |
| 124937104 | 12493710 | Haemothorax | |
| 124937104 | 12493710 | Hand fracture | |
| 124937104 | 12493710 | International normalised ratio increased | |
| 124937104 | 12493710 | Laceration | |
| 124937104 | 12493710 | Pulmonary haemorrhage | |
| 124937104 | 12493710 | Rib fracture | |
| 124937104 | 12493710 | Subcutaneous haematoma |
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 |
|---|---|---|---|---|---|---|
| 124937104 | 12493710 | 1 | 20160316 | 20160621 | 0 | |
| 124937104 | 12493710 | 3 | 20160621 | 0 |