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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125252241 | 12525224 | 1 | I | 20160417 | 20160418 | 20160704 | 20160704 | EXP | ES-JNJFOC-20160424220 | PHARMACYCLICS | 75.17 | YR | E | M | Y | 60.00000 | KG | 20160704 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125252241 | 12525224 | 1 | SS | blinded; IBRUTINI | IBRUTINIB | 1 | Y | N | 0 | CAPSULE | |||||||||
| 125252241 | 12525224 | 2 | SS | blinded; IBRUTINI | IBRUTINIB | 1 | Y | N | 0 | CAPSULE | |||||||||
| 125252241 | 12525224 | 3 | PS | blinded; IBRUTINI | IBRUTINIB | 1 | Y | N | 205552 | CAPSULE | |||||||||
| 125252241 | 12525224 | 4 | SS | blinded; IBRUTINI | IBRUTINIB | 1 | Y | N | 124674 | CAPSULE | |||||||||
| 125252241 | 12525224 | 5 | SS | PLACEBO | UNSPECIFIED INGREDIENT | 1 | Y | 0 | CAPSULE | ||||||||||
| 125252241 | 12525224 | 6 | SS | PLACEBO | UNSPECIFIED INGREDIENT | 1 | Y | 0 | CAPSULE | ||||||||||
| 125252241 | 12525224 | 7 | SS | PLACEBO | UNSPECIFIED INGREDIENT | 1 | Y | 0 | CAPSULE | ||||||||||
| 125252241 | 12525224 | 8 | SS | PLACEBO | UNSPECIFIED INGREDIENT | 1 | Y | 0 | CAPSULE | ||||||||||
| 125252241 | 12525224 | 9 | SS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 600 MG/M2, DAYS 1, 8, 15 | Y | N | 0 | 600 | MG/M**2 | INTRAVENOUS INFUSION | |||||
| 125252241 | 12525224 | 10 | SS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 800 MG/M2, DAYS 1, 8, 15 | Y | N | 0 | 800 | MG/M**2 | INTRAVENOUS INFUSION | |||||
| 125252241 | 12525224 | 11 | SS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 800 MG/M2, DAYS 1, 8, 15 | Y | N | 0 | 800 | MG/M**2 | INTRAVENOUS INFUSION | |||||
| 125252241 | 12525224 | 12 | SS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 1000 MG/M2, DAYS 1, 8, 15 | Y | N | 0 | 1000 | MG/M**2 | INTRAVENOUS INFUSION | |||||
| 125252241 | 12525224 | 13 | SS | NAB-PACLITAXEL | PACLITAXEL | 1 | Intravenous (not otherwise specified) | 125 MG/M2, DAYS 1, 8, 15 | Y | N | 0 | 125 | MG/M**2 | INTRAVENOUS INFUSION | |||||
| 125252241 | 12525224 | 14 | SS | NAB-PACLITAXEL | PACLITAXEL | 1 | Intravenous (not otherwise specified) | 75 MG/M2, DAYS 1, 8, 15 | Y | N | 0 | 75 | MG/M**2 | INTRAVENOUS INFUSION | |||||
| 125252241 | 12525224 | 15 | SS | NAB-PACLITAXEL | PACLITAXEL | 1 | Intravenous (not otherwise specified) | 100 MG/M2, DAYS 1, 8, 15 | Y | N | 0 | 100 | MG/M**2 | INTRAVENOUS INFUSION | |||||
| 125252241 | 12525224 | 16 | SS | NAB-PACLITAXEL | PACLITAXEL | 1 | Intravenous (not otherwise specified) | 100 MG/M2, DAYS 1, 8, 15 | Y | N | 0 | 100 | MG/M**2 | INTRAVENOUS INFUSION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125252241 | 12525224 | 1 | Pancreatic carcinoma metastatic |
| 125252241 | 12525224 | 2 | Pancreatic carcinoma metastatic |
| 125252241 | 12525224 | 3 | Pancreatic carcinoma metastatic |
| 125252241 | 12525224 | 4 | Pancreatic carcinoma metastatic |
| 125252241 | 12525224 | 5 | Pancreatic carcinoma metastatic |
| 125252241 | 12525224 | 6 | Pancreatic carcinoma metastatic |
| 125252241 | 12525224 | 7 | Pancreatic carcinoma metastatic |
| 125252241 | 12525224 | 8 | Pancreatic carcinoma metastatic |
| 125252241 | 12525224 | 9 | Pancreatic carcinoma metastatic |
| 125252241 | 12525224 | 10 | Pancreatic carcinoma metastatic |
| 125252241 | 12525224 | 11 | Pancreatic carcinoma metastatic |
| 125252241 | 12525224 | 12 | Pancreatic carcinoma metastatic |
| 125252241 | 12525224 | 13 | Pancreatic carcinoma metastatic |
| 125252241 | 12525224 | 14 | Pancreatic carcinoma metastatic |
| 125252241 | 12525224 | 15 | Pancreatic carcinoma metastatic |
| 125252241 | 12525224 | 16 | Pancreatic carcinoma metastatic |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125252241 | 12525224 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125252241 | 12525224 | Anaemia | |
| 125252241 | 12525224 | Gastrointestinal haemorrhage | |
| 125252241 | 12525224 | Neutropenia | |
| 125252241 | 12525224 | Platelet count decreased | |
| 125252241 | 12525224 | Pyrexia |
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 |
|---|---|---|---|---|---|---|
| 125252241 | 12525224 | 1 | 20160511 | 20160519 | 0 | |
| 125252241 | 12525224 | 2 | 20160601 | 20160613 | 0 | |
| 125252241 | 12525224 | 3 | 20160623 | 0 | ||
| 125252241 | 12525224 | 4 | 20160407 | 20160417 | 0 | |
| 125252241 | 12525224 | 5 | 20160511 | 20160519 | 0 | |
| 125252241 | 12525224 | 6 | 20160407 | 20160417 | 0 | |
| 125252241 | 12525224 | 7 | 20160623 | 0 | ||
| 125252241 | 12525224 | 8 | 20160601 | 20160613 | 0 | |
| 125252241 | 12525224 | 9 | 20160623 | 0 | ||
| 125252241 | 12525224 | 10 | 20160601 | 20160613 | 0 | |
| 125252241 | 12525224 | 11 | 20160511 | 20160613 | 0 | |
| 125252241 | 12525224 | 12 | 20160407 | 20160417 | 0 | |
| 125252241 | 12525224 | 13 | 20160407 | 20160417 | 0 | |
| 125252241 | 12525224 | 14 | 20160623 | 0 | ||
| 125252241 | 12525224 | 15 | 20160601 | 20160613 | 0 | |
| 125252241 | 12525224 | 16 | 20160511 | 20160519 | 0 |