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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125837701 | 12583770 | 1 | I | 20160712 | 20160722 | 20160722 | EXP | JP-ELI_LILLY_AND_COMPANY-JP201607007156 | ELI LILLY AND CO | 0.00 | E | Y | 0.00000 | 20160721 | OT | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125837701 | 12583770 | 1 | PS | Cetuximab | CETUXIMAB | 1 | Intravenous (not otherwise specified) | 400 MG/M2, WEEKLY (1/W) | U | U | 125084 | 400 | MG/M**2 | INJECTION | /wk | ||||
| 125837701 | 12583770 | 2 | SS | Cetuximab | CETUXIMAB | 1 | Intravenous (not otherwise specified) | 250 MG/M2, WEEKLY (1/W) | U | U | 125084 | 250 | MG/M**2 | INJECTION | /wk | ||||
| 125837701 | 12583770 | 3 | SS | CISPLATIN. | CISPLATIN | 1 | 100 MG/M2, UNK | U | 0 | 100 | MG/M**2 | ||||||||
| 125837701 | 12583770 | 4 | SS | 5-FLUOROURACIL /00098801/ | FLUOROURACIL | 1 | 1000 MG/M2, UNK | U | 0 | 1000 | MG/M**2 | ||||||||
| 125837701 | 12583770 | 5 | SS | PACLITAXEL. | PACLITAXEL | 1 | U | 0 | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125837701 | 12583770 | 1 | Squamous cell carcinoma of the oral cavity |
| 125837701 | 12583770 | 3 | Squamous cell carcinoma of the oral cavity |
| 125837701 | 12583770 | 4 | Squamous cell carcinoma of the oral cavity |
| 125837701 | 12583770 | 5 | Squamous cell carcinoma of the oral cavity |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125837701 | 12583770 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125837701 | 12583770 | Metastases to central nervous system | |
| 125837701 | 12583770 | Off label use |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |