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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123962562 | 12396256 | 2 | F | 20151224 | 20160921 | 20160524 | 20160923 | EXP | US-ROCHE-1689666 | ROCHE | 84.00 | YR | M | Y | 59.00000 | KG | 20160923 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123962562 | 12396256 | 1 | PS | Vemurafenib | VEMURAFENIB | 1 | Oral | TOTAL DOSE ADMINISTERED TILL THIS COURSE: 15360 MG.?LAST DOSE PRIOR TO AE ON: 15/JAN/2016 | Y | 202429 | 960 | MG | TABLET | BID | |||||
| 123962562 | 12396256 | 2 | SS | Vemurafenib | VEMURAFENIB | 1 | Oral | C7D1 06/MAY/2016-13/MAY/2016 | Y | 202429 | 14400 | MG | TABLET | BID | |||||
| 123962562 | 12396256 | 3 | SS | Vemurafenib | VEMURAFENIB | 1 | Oral | CYCLE 10?LAST DOSE PRIOR TO EVENT: 23/AUG/2016 | Y | 202429 | TABLET | ||||||||
| 123962562 | 12396256 | 4 | SS | Vemurafenib | VEMURAFENIB | 1 | Oral | Y | 202429 | TABLET | |||||||||
| 123962562 | 12396256 | 5 | SS | CETUXIMAB | CETUXIMAB | 1 | Intravenous (not otherwise specified) | LAST ADMINISTERED DATE: 22/DEC/2015 | Y | 0 | 900 | MG | |||||||
| 123962562 | 12396256 | 6 | SS | CETUXIMAB | CETUXIMAB | 1 | Intravenous (not otherwise specified) | MOST RECENT DOSE: 06/MAY/2016 | Y | 0 | 876 | MG | |||||||
| 123962562 | 12396256 | 7 | SS | CETUXIMAB | CETUXIMAB | 1 | Intravenous (not otherwise specified) | DATE OF LAST DOSE PRIOR TO EVENT: 10/AUG/2016 | Y | 0 | 1732 | MG | |||||||
| 123962562 | 12396256 | 8 | SS | CETUXIMAB | CETUXIMAB | 1 | Intravenous (not otherwise specified) | Y | 0 | ||||||||||
| 123962562 | 12396256 | 9 | SS | IRINOTECAN | IRINOTECAN | 1 | Intravenous (not otherwise specified) | LAST ADMINISTERED DATE: 22/DEC/2015 | Y | 0 | 324 | MG | |||||||
| 123962562 | 12396256 | 10 | SS | IRINOTECAN | IRINOTECAN | 1 | Intravenous (not otherwise specified) | Y | 0 | ||||||||||
| 123962562 | 12396256 | 11 | SS | IRINOTECAN | IRINOTECAN | 1 | Intravenous (not otherwise specified) | MOST RECENT DOSE: 06/MAY/2016 | Y | 0 | 260 | MG | |||||||
| 123962562 | 12396256 | 12 | SS | IRINOTECAN | IRINOTECAN | 1 | Intravenous (not otherwise specified) | DATE OF LAST DOSE PRIOR TO EVENT: 10/AUG/2016 | Y | 0 | |||||||||
| 123962562 | 12396256 | 13 | SS | IRINOTECAN | IRINOTECAN | 1 | Intravenous (not otherwise specified) | Y | 0 | ||||||||||
| 123962562 | 12396256 | 14 | C | 5-FLUOROURACIL | FLUOROURACIL | 1 | Unknown | 0 | |||||||||||
| 123962562 | 12396256 | 15 | C | 5-FLUOROURACIL | FLUOROURACIL | 1 | Unknown | 0 | |||||||||||
| 123962562 | 12396256 | 16 | C | ELOXATIN | OXALIPLATIN | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123962562 | 12396256 | 1 | Colorectal cancer metastatic |
| 123962562 | 12396256 | 5 | Colorectal cancer metastatic |
| 123962562 | 12396256 | 9 | Colorectal cancer metastatic |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123962562 | 12396256 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123962562 | 12396256 | Anaemia | |
| 123962562 | 12396256 | Febrile neutropenia | |
| 123962562 | 12396256 | Headache | |
| 123962562 | 12396256 | Small intestinal haemorrhage | |
| 123962562 | 12396256 | Small intestinal obstruction |
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 |
|---|---|---|---|---|---|---|
| 123962562 | 12396256 | 1 | 20151222 | 20151227 | 0 | |
| 123962562 | 12396256 | 2 | 20160506 | 20160513 | 0 | |
| 123962562 | 12396256 | 3 | 20160727 | 20160823 | 0 | |
| 123962562 | 12396256 | 4 | 20151002 | 0 | ||
| 123962562 | 12396256 | 5 | 20151222 | 0 | ||
| 123962562 | 12396256 | 6 | 20160506 | 0 | ||
| 123962562 | 12396256 | 7 | 20160727 | 20160802 | 0 | |
| 123962562 | 12396256 | 8 | 20151002 | 0 | ||
| 123962562 | 12396256 | 9 | 20151222 | 20151222 | 0 | |
| 123962562 | 12396256 | 10 | 201506 | 201508 | 0 | |
| 123962562 | 12396256 | 11 | 20160506 | 0 | ||
| 123962562 | 12396256 | 12 | 20160727 | 20160810 | 0 | |
| 123962562 | 12396256 | 13 | 20151002 | 0 | ||
| 123962562 | 12396256 | 14 | 20150302 | 20150413 | 0 | |
| 123962562 | 12396256 | 15 | 201506 | 201508 | 0 | |
| 123962562 | 12396256 | 16 | 20150302 | 20150413 | 0 |