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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109048002 | 10904800 | 2 | F | 20160805 | 20150311 | 20160819 | EXP | FR-CIPLA LTD.-2015FR01739 | CIPLA | 0.00 | Y | 0.00000 | 20160819 | OT | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109048002 | 10904800 | 1 | PS | Irinotecan | IRINOTECAN | 1 | Intravenous (not otherwise specified) | 180 MG/M2, OVER 90 MIN | U | U | 0 | 180 | MG/M**2 | ||||||
| 109048002 | 10904800 | 2 | SS | Irinotecan | IRINOTECAN | 1 | U | U | 0 | ||||||||||
| 109048002 | 10904800 | 3 | SS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | UNK, FIRST LINE CHEMOTHERAPY | U | U | 0 | ||||||||
| 109048002 | 10904800 | 4 | SS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | U | U | 0 | ||||||||||
| 109048002 | 10904800 | 5 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous (not otherwise specified) | 400 MG/M2, BOLUS | U | U | 0 | 400 | MG/M**2 | INFUSION | |||||
| 109048002 | 10904800 | 6 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Intravenous (not otherwise specified) | 2400 MG/M2, OVER 46 H | U | U | 0 | 2400 | MG/M**2 | INFUSION | |||||
| 109048002 | 10904800 | 7 | SS | OXALIPLATIN. | OXALIPLATIN | 1 | Intravenous (not otherwise specified) | UNK, FIRST LINE CHEMOTHERAPY | U | U | 0 | ||||||||
| 109048002 | 10904800 | 8 | SS | OXALIPLATIN. | OXALIPLATIN | 1 | U | U | 0 | ||||||||||
| 109048002 | 10904800 | 9 | SS | Folinic acid | LEUCOVORIN | 1 | Intravenous (not otherwise specified) | 400 MG/M2, OVER 120 MIN | U | U | 0 | 400 | MG/M**2 | ||||||
| 109048002 | 10904800 | 10 | SS | Folinic acid | LEUCOVORIN | 1 | U | U | 0 | ||||||||||
| 109048002 | 10904800 | 11 | SS | Bevacizumab | BEVACIZUMAB | 1 | Unknown | 5 MG/KG, EVERY 2 WEEKS | U | U | 0 | 5 | MG/KG | INJECTION | |||||
| 109048002 | 10904800 | 12 | SS | Bevacizumab | BEVACIZUMAB | 1 | U | U | 0 | INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 109048002 | 10904800 | 1 | Cholangiocarcinoma |
| 109048002 | 10904800 | 2 | Cholangiocarcinoma |
| 109048002 | 10904800 | 3 | Cholangiocarcinoma |
| 109048002 | 10904800 | 4 | Cholangiocarcinoma |
| 109048002 | 10904800 | 5 | Cholangiocarcinoma |
| 109048002 | 10904800 | 6 | Cholangiocarcinoma |
| 109048002 | 10904800 | 7 | Cholangiocarcinoma |
| 109048002 | 10904800 | 8 | Cholangiocarcinoma |
| 109048002 | 10904800 | 9 | Cholangiocarcinoma |
| 109048002 | 10904800 | 10 | Cholangiocarcinoma |
| 109048002 | 10904800 | 11 | Cholangiocarcinoma |
| 109048002 | 10904800 | 12 | Cholangiocarcinoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 109048002 | 10904800 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 109048002 | 10904800 | Disease progression | |
| 109048002 | 10904800 | Gastrointestinal toxicity | |
| 109048002 | 10904800 | Treatment failure |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |