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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126004401 | 12600440 | 1 | I | 20160718 | 20160727 | 20160727 | EXP | BE-FRESENIUS KABI-FK201604847 | FRESENIUS KABI | SZTURZ P,SPECENIER P,VAN LAER C,VAN DEN WEYNGAERT D,CORTHOUTS B,CARP L. LONG-TERM REMISSION OF LOCALLY RECURRENT OROPHARYNGEAL CANCER AFTER DOCETAXEL-BASED CHEMOTHERAPY PLUS CETUXIMAB.. EUR-ARCH-OTORHINOLARYNGOL 2016;273 (6):1629-1636. | 57.00 | YR | M | Y | 0.00000 | 20160727 | OT | BE | BE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126004401 | 12600440 | 1 | PS | FLUOROURACIL (Manufacturer unknown) | FLUOROURACIL | 1 | Unknown | U | UNKNOWN | 40278 | 1000 | MG/M**2 | UNKNOWN | ||||||
| 126004401 | 12600440 | 2 | SS | FLUOROURACIL (Manufacturer unknown) | FLUOROURACIL | 1 | Unknown | U | UNKNOWN | 40278 | 750 | MG/M**2 | UNKNOWN | ||||||
| 126004401 | 12600440 | 3 | SS | CISPLATIN (Manufacturer unknown) | CISPLATIN | 1 | Unknown | U | UNKNOWN | 74735 | 100 | MG/M**2 | UNKNOWN | ||||||
| 126004401 | 12600440 | 4 | SS | CISPLATIN (Manufacturer unknown) | CISPLATIN | 1 | Unknown | U | UNKNOWN | 74735 | 75 | MG/M**2 | UNKNOWN | ||||||
| 126004401 | 12600440 | 5 | SS | DOCETAXEL (Manufacturer unknown) | DOCETAXEL | 1 | Unknown | U | 0 | 75 | MG/M**2 | UNKNOWN | |||||||
| 126004401 | 12600440 | 6 | SS | CETUXIMAB | CETUXIMAB | 1 | 0 | 400 | MG/M**2 | ||||||||||
| 126004401 | 12600440 | 7 | SS | CETUXIMAB | CETUXIMAB | 1 | 0 | 250 | MG/M**2 | ||||||||||
| 126004401 | 12600440 | 8 | SS | CETUXIMAB | CETUXIMAB | 1 | 0 | 250 | MG/M**2 | ||||||||||
| 126004401 | 12600440 | 9 | SS | CETUXIMAB | CETUXIMAB | 1 | 0 | 400 | MG/M**2 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126004401 | 12600440 | 1 | Oropharyngeal cancer |
| 126004401 | 12600440 | 3 | Oropharyngeal cancer |
| 126004401 | 12600440 | 5 | Oropharyngeal cancer |
| 126004401 | 12600440 | 6 | Oropharyngeal cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126004401 | 12600440 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126004401 | 12600440 | Alopecia | |
| 126004401 | 12600440 | Deafness | |
| 126004401 | 12600440 | Decreased appetite | |
| 126004401 | 12600440 | Diarrhoea | |
| 126004401 | 12600440 | Dizziness | |
| 126004401 | 12600440 | Fatigue | |
| 126004401 | 12600440 | Febrile neutropenia | |
| 126004401 | 12600440 | Hypotension | |
| 126004401 | 12600440 | Infection | |
| 126004401 | 12600440 | Nausea | |
| 126004401 | 12600440 | Peripheral sensory neuropathy | |
| 126004401 | 12600440 | Rash |
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 |
|---|---|---|---|---|---|---|
| 126004401 | 12600440 | 1 | 20050509 | 20050906 | 0 | |
| 126004401 | 12600440 | 2 | 20160614 | 0 | ||
| 126004401 | 12600440 | 3 | 20050509 | 20050906 | 0 | |
| 126004401 | 12600440 | 4 | 20160614 | 0 | ||
| 126004401 | 12600440 | 5 | 20160614 | 0 | ||
| 126004401 | 12600440 | 6 | 20050509 | 20050906 | 0 | |
| 126004401 | 12600440 | 7 | 20050509 | 20050906 | 0 | |
| 126004401 | 12600440 | 8 | 20160614 | 0 | ||
| 126004401 | 12600440 | 9 | 20160614 | 0 |