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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1034126913 | 10341269 | 13 | F | 20140629 | 20160825 | 20140725 | 20160829 | EXP | US-ROCHE-1428425 | ROCHE | 73.97 | YR | F | Y | 77.00000 | KG | 20160829 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1034126913 | 10341269 | 1 | PS | Bevacizumab | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | DATE OF LAST DOSE PRIOR TO SAE AT 329 MG ON 20/JUN/2014?29/JUN/2015: THERAPY INTERRUPTED INRESPONSE | Y | 1120729 | 7023 | 5 | MG/KG | QOW | |||||
| 1034126913 | 10341269 | 2 | SS | Bevacizumab | BEVACIZUMAB | 1 | Y | 1120729 | 7023 | ||||||||||
| 1034126913 | 10341269 | 3 | SS | OXALIPLATIN. | OXALIPLATIN | 1 | Intravenous (not otherwise specified) | DATE OF LAST DOSE PRIOR TO SAE : 06 JUN 2014?11/JUL/2014: THERAPY INTERRUPTED INRESPONSE TO HYPOKALE | Y | 0 | 65 | MG/M**2 | QOW | ||||||
| 1034126913 | 10341269 | 4 | SS | OXALIPLATIN. | OXALIPLATIN | 1 | Y | 0 | |||||||||||
| 1034126913 | 10341269 | 5 | SS | 5-FLUOROURACIL | FLUOROURACIL | 1 | Intravenous (not otherwise specified) | DATE OF LAST DOSE PRIOR TO SAE : 20/JUN/2014?3321.6 MG?29/JUN/2015: THERAPY INTERRUPTED INRESPONSE T | 0 | 1920 | MG/M**2 | INFUSION | QOW | ||||||
| 1034126913 | 10341269 | 6 | SS | 5-FLUOROURACIL | FLUOROURACIL | 1 | Intravenous bolus | DATE OF LAST DOSE PRIOR TO SAE : 20 JUN 2014?692 MG?11/JUL/2014: THERAPY INTERRUPTED INRESPONSE TO H | 0 | 400 | MG/M**2 | QOW | |||||||
| 1034126913 | 10341269 | 7 | SS | IRINOTECAN | IRINOTECAN | 1 | Intravenous (not otherwise specified) | DATE OF LAST DOSE PRIOR TO SAE : 20 JUN 2014?311 MG?29/JUN/2015: THERAPY INTERRUPTED INRESPONSE TO N | Y | 0 | 180 | MG/M**2 | |||||||
| 1034126913 | 10341269 | 8 | SS | CALCIUM FOLINATE | LEUCOVORIN CALCIUM | 1 | Intravenous (not otherwise specified) | DATE OF LAST DOSE PRIOR TO SAE : 20 JUN 2014 AT 692 MG?11/JUL/2014: THERAPY INTERRUPTED INRESPONSE T | Y | 0 | 400 | MG/M**2 | QOW |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1034126913 | 10341269 | 1 | Colorectal cancer metastatic |
| 1034126913 | 10341269 | 2 | Rectal cancer |
| 1034126913 | 10341269 | 3 | Colorectal cancer metastatic |
| 1034126913 | 10341269 | 4 | Rectal cancer |
| 1034126913 | 10341269 | 5 | Colorectal cancer metastatic |
| 1034126913 | 10341269 | 6 | Rectal cancer |
| 1034126913 | 10341269 | 7 | Colorectal cancer metastatic |
| 1034126913 | 10341269 | 8 | Colorectal cancer metastatic |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1034126913 | 10341269 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1034126913 | 10341269 | Encephalopathy | |
| 1034126913 | 10341269 | Hypertension | |
| 1034126913 | 10341269 | Hypokalaemia | |
| 1034126913 | 10341269 | Neutropenic sepsis |
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 |
|---|---|---|---|---|---|---|
| 1034126913 | 10341269 | 1 | 20140516 | 0 | ||
| 1034126913 | 10341269 | 3 | 20140516 | 0 | ||
| 1034126913 | 10341269 | 5 | 20140516 | 0 | ||
| 1034126913 | 10341269 | 6 | 20140516 | 0 | ||
| 1034126913 | 10341269 | 7 | 20140620 | 20140713 | 0 | |
| 1034126913 | 10341269 | 8 | 20140516 | 0 |