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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126352011 | 12635201 | 1 | I | 20160727 | 20160728 | 20160809 | 20160809 | EXP | ES-JNJFOC-20160803126 | PHARMACYCLICS | 75.45 | YR | E | M | Y | 59.00000 | KG | 20160809 | MD | ES | ES |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126352011 | 12635201 | 1 | PS | blinded; IBRUTINI | IBRUTINIB | 1 | N | 205552 | CAPSULE | ||||||||||
| 126352011 | 12635201 | 2 | SS | blinded; IBRUTINI | IBRUTINIB | 1 | N | 124674 | CAPSULE | ||||||||||
| 126352011 | 12635201 | 3 | SS | PLACEBO | UNSPECIFIED INGREDIENT | 1 | 0 | CAPSULE | |||||||||||
| 126352011 | 12635201 | 4 | SS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | N | 0 | 1000 | MG/M**2 | INTRAVENOUS INFUSION | |||||||
| 126352011 | 12635201 | 5 | SS | NAB-PACLITAXEL | PACLITAXEL | 1 | Intravenous (not otherwise specified) | N | 0 | 125 | MG/M**2 | INTRAVENOUS INFUSION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126352011 | 12635201 | 2 | Pancreatic carcinoma metastatic |
| 126352011 | 12635201 | 3 | Pancreatic carcinoma metastatic |
| 126352011 | 12635201 | 4 | Pancreatic carcinoma metastatic |
| 126352011 | 12635201 | 5 | Pancreatic carcinoma metastatic |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126352011 | 12635201 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126352011 | 12635201 | Gastrointestinal haemorrhage | |
| 126352011 | 12635201 | Neutropenia | |
| 126352011 | 12635201 | Thrombocytopenia |
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 |
|---|---|---|---|---|---|---|
| 126352011 | 12635201 | 2 | 20160407 | 0 | ||
| 126352011 | 12635201 | 3 | 20160407 | 0 | ||
| 126352011 | 12635201 | 4 | 20160407 | 0 | ||
| 126352011 | 12635201 | 5 | 20160407 | 0 |