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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126191604 | 12619160 | 4 | F | 20160708 | 20160907 | 20160803 | 20160914 | EXP | IT-GILEAD-2016-0225424 | GILEAD | 53.00 | YR | A | F | Y | 83.00000 | KG | 20160914 | MD | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126191604 | 12619160 | 1 | PS | ZYDELIG | IDELALISIB | 1 | Oral | 300 MG, QD | 64200 | MG | N | 205858 | 300 | MG | TABLET | QD | |||
| 126191604 | 12619160 | 2 | SS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | 865 MG, 1 VIAL 50 MG/50ML | N | 0 | 865 | MG | /cycle | ||||||
| 126191604 | 12619160 | 3 | C | VALACICLOVIR | VALACYCLOVIR HYDROCHLORIDE | 1 | Oral | 1 G, UNK | 0 | 1 | G | ||||||||
| 126191604 | 12619160 | 4 | C | SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126191604 | 12619160 | 1 | Chronic lymphocytic leukaemia |
| 126191604 | 12619160 | 2 | Chronic lymphocytic leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126191604 | 12619160 | HO |
| 126191604 | 12619160 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126191604 | 12619160 | Central nervous system lesion | |
| 126191604 | 12619160 | Progressive multifocal leukoencephalopathy | |
| 126191604 | 12619160 | Visual acuity reduced |
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 |
|---|---|---|---|---|---|---|
| 126191604 | 12619160 | 1 | 20151207 | 20160714 | 0 | |
| 126191604 | 12619160 | 2 | 20151207 | 20160714 | 0 |