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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121038648 | 12103864 | 8 | F | 20160208 | 20160922 | 20160223 | 20160927 | EXP | US-ROCHE-1712885 | ROCHE | 62.00 | YR | F | Y | 48.40000 | KG | 20160927 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121038648 | 12103864 | 1 | PS | Vemurafenib | VEMURAFENIB | 1 | Oral | LAST DOSE PRIOR TO SERIOUS ADVERSE EVENT ON 08/FEB/2016?TREATMENT ARM 3: S/P CYCLE 2 DAY 1 | U | 202429 | 960 | MG | TABLET | BID | |||||
| 121038648 | 12103864 | 2 | SS | Vemurafenib | VEMURAFENIB | 1 | Oral | DOSE REDUCED | U | 202429 | 720 | MG | TABLET | ||||||
| 121038648 | 12103864 | 3 | SS | CETUXIMAB | CETUXIMAB | 1 | Intravenous (not otherwise specified) | LAST DOSE PRIOR TO SERIOUS ADVERSE EVENT ON 11/JAN/2016, MOST RECENT DOSE ON 29/FEB/2016 (766MG)?TRE | 0 | 500 | MG/M**2 | ||||||||
| 121038648 | 12103864 | 4 | SS | IRINOTECAN | IRINOTECAN | 1 | Intravenous (not otherwise specified) | LAST DOSE PRIOR TO SERIOUS ADVERSE EVENT ON 11/JAN/2016, MOST RECENT DOSE ON 29/FEB/2016 (280 MG)?TR | 0 | 180 | MG/M**2 | ||||||||
| 121038648 | 12103864 | 5 | SS | IRINOTECAN | IRINOTECAN | 1 | Intravenous (not otherwise specified) | 0 | |||||||||||
| 121038648 | 12103864 | 6 | C | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | 0 | ||||||||||||
| 121038648 | 12103864 | 7 | C | 5-FLUOROURACIL | FLUOROURACIL | 1 | Unknown | 0 | |||||||||||
| 121038648 | 12103864 | 8 | C | 5-FLUOROURACIL | FLUOROURACIL | 1 | Unknown | 0 | |||||||||||
| 121038648 | 12103864 | 9 | C | 5-FLUOROURACIL | FLUOROURACIL | 1 | Unknown | 0 | |||||||||||
| 121038648 | 12103864 | 10 | C | Bevacizumab | BEVACIZUMAB | 1 | Unknown | 0 | |||||||||||
| 121038648 | 12103864 | 11 | C | ZOSYN | PIPERACILLIN SODIUMTAZOBACTAM SODIUM | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121038648 | 12103864 | 1 | Adenocarcinoma of colon |
| 121038648 | 12103864 | 3 | Adenocarcinoma of colon |
| 121038648 | 12103864 | 4 | Adenocarcinoma of colon |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121038648 | 12103864 | OT |
| 121038648 | 12103864 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121038648 | 12103864 | Abdominal pain | |
| 121038648 | 12103864 | Dermatitis acneiform | |
| 121038648 | 12103864 | Gastritis | |
| 121038648 | 12103864 | Neutrophil count decreased | |
| 121038648 | 12103864 | Rash maculo-papular | |
| 121038648 | 12103864 | Upper respiratory tract infection |
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 |
|---|---|---|---|---|---|---|
| 121038648 | 12103864 | 1 | 20150211 | 0 | ||
| 121038648 | 12103864 | 2 | 20160313 | 0 | ||
| 121038648 | 12103864 | 3 | 20150211 | 0 | ||
| 121038648 | 12103864 | 4 | 20150211 | 0 | ||
| 121038648 | 12103864 | 5 | 201412 | 201506 | 0 | |
| 121038648 | 12103864 | 7 | 201409 | 201411 | 0 | |
| 121038648 | 12103864 | 8 | 201412 | 201506 | 0 | |
| 121038648 | 12103864 | 9 | 201507 | 201509 | 0 | |
| 121038648 | 12103864 | 10 | 201412 | 201506 | 0 |