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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125180592 | 12518059 | 2 | F | 20160627 | 20160630 | 20160816 | PER | US-APOTEX-2016AP009277 | APOTEX | SELIM K, ELHAZIN B, LONG W, KARMANOVA M, SALAZAR J, VOLK M.. SAFETY AND TOLERABILITY OF RECURRENT HEPATITIS C TREATMENT IN POST LIVER AND LIVER/KIDNEY TRANSPLANT PATIENTS TREATED WITH LEDIPASVIR/SOFOSBUVIR WITH AND WITHOUT RIBAVIRIN OR SOFOSBUVIR WITH RIBAVIRIN: SINGLE CENTER EXPERIENCE.. J-HEPATOL. 2016;64 (SUPPL.1)(2):S788-S789 ABSTR. SAT-197 | 0.00 | Y | 0.00000 | 20160816 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125180592 | 12518059 | 1 | PS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | UNK, UNKNOWN | 90499 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125180592 | 12518059 | 1 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125180592 | 12518059 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125180592 | 12518059 | Neutropenia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |