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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126350883 | 12635088 | 3 | F | 201405 | 20160830 | 20160809 | 20160909 | EXP | US-JNJFOC-20160624064 | PHARMACYCLICS | 60.49 | YR | A | F | Y | 60.00000 | KG | 20160909 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126350883 | 12635088 | 1 | SS | IMBRUVICA | IBRUTINIB | 1 | Oral | Y | U | L0502856A1;0502856A1 | 0 | 140 | MG | CAPSULE | QD | ||||
| 126350883 | 12635088 | 2 | SS | IMBRUVICA | IBRUTINIB | 1 | Oral | Y | U | L0502856A1;0502856A1 | 0 | 560 | MG | CAPSULE | QD | ||||
| 126350883 | 12635088 | 3 | SS | IMBRUVICA | IBRUTINIB | 1 | Oral | Y | U | L0502856A1;0502856A1 | 0 | 560 | MG | CAPSULE | QD | ||||
| 126350883 | 12635088 | 4 | PS | IMBRUVICA | IBRUTINIB | 1 | Oral | Y | U | L0502856A1;0502856A1 | 205552 | 560 | MG | CAPSULE | QD | ||||
| 126350883 | 12635088 | 5 | SS | ALBUTEROL. | ALBUTEROL | 1 | Unknown | Y | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126350883 | 12635088 | 1 | Marginal zone lymphoma |
| 126350883 | 12635088 | 2 | Marginal zone lymphoma |
| 126350883 | 12635088 | 3 | Marginal zone lymphoma |
| 126350883 | 12635088 | 4 | Marginal zone lymphoma |
| 126350883 | 12635088 | 5 | Bronchitis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126350883 | 12635088 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126350883 | 12635088 | Anaemia | |
| 126350883 | 12635088 | Arrhythmia | |
| 126350883 | 12635088 | Blood alkaline phosphatase increased | |
| 126350883 | 12635088 | Blood count abnormal | |
| 126350883 | 12635088 | Bronchitis | |
| 126350883 | 12635088 | Dehydration | |
| 126350883 | 12635088 | Fatigue | |
| 126350883 | 12635088 | Insomnia | |
| 126350883 | 12635088 | Malaise | |
| 126350883 | 12635088 | Nasopharyngitis | |
| 126350883 | 12635088 | Nausea | |
| 126350883 | 12635088 | Night sweats | |
| 126350883 | 12635088 | Off label use | |
| 126350883 | 12635088 | Product use issue | |
| 126350883 | 12635088 | Pyrexia | |
| 126350883 | 12635088 | Thrombocytopenia | |
| 126350883 | 12635088 | Tremor |
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 |
|---|---|---|---|---|---|---|
| 126350883 | 12635088 | 1 | 20160613 | 20160719 | 0 | |
| 126350883 | 12635088 | 3 | 201405 | 20160724 | 0 | |
| 126350883 | 12635088 | 4 | 20160518 | 0 | ||
| 126350883 | 12635088 | 5 | 201607 | 0 |