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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126370141 | 12637014 | 1 | I | 20110803 | 20160706 | 20160809 | 20160809 | EXP | US-ASTELLAS-2016US030361 | ASTELLAS | 79.00 | YR | F | Y | 0.00000 | 20160809 | CN | GB | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126370141 | 12637014 | 1 | PS | Erlotinib | ERLOTINIB | 1 | Oral | 75 MG ONCE DAILY,TOTAL DOSE ADMINISTERED: 525 MG | 525 | MG | Y | 21743 | 75 | MG | TABLET | QD | |||
| 126370141 | 12637014 | 2 | SS | VISMODEGIB | VISMODEGIB | 1 | Oral | TOTAL DOSE ADMINISTERED:1050 MG, ONCE DAILY | 7350 | MG | Y | 0 | 1050 | MG | CAPSULE | QD | |||
| 126370141 | 12637014 | 3 | SS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 1000 MG/M2, ONCE WEEKLY, TOTAL DOSE ADMINISTERED:1000 MG, OVER 30 MINUTES. | 1000 | MG/M2 | Y | 0 | 1000 | MG/M**2 | FORMULATION UNKNOWN | /wk | |||
| 126370141 | 12637014 | 4 | C | ATIVAN | LORAZEPAM | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 126370141 | 12637014 | 5 | C | CREON | PANCRELIPASE AMYLASEPANCRELIPASE LIPASEPANCRELIPASE PROTEASE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 126370141 | 12637014 | 6 | C | LOVENOX | ENOXAPARIN SODIUM | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126370141 | 12637014 | 1 | Adenocarcinoma pancreas |
| 126370141 | 12637014 | 2 | Adenocarcinoma pancreas |
| 126370141 | 12637014 | 3 | Adenocarcinoma pancreas |
| 126370141 | 12637014 | 4 | Product used for unknown indication |
| 126370141 | 12637014 | 5 | Product used for unknown indication |
| 126370141 | 12637014 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126370141 | 12637014 | OT |
| 126370141 | 12637014 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126370141 | 12637014 | Abdominal pain | |
| 126370141 | 12637014 | Neutrophil count decreased | |
| 126370141 | 12637014 | White blood cell count decreased |
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 |
|---|---|---|---|---|---|---|
| 126370141 | 12637014 | 1 | 20110728 | 20110803 | 0 | |
| 126370141 | 12637014 | 2 | 20110728 | 20110803 | 0 | |
| 126370141 | 12637014 | 3 | 20110728 | 20110728 | 0 |