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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125610642 | 12561064 | 2 | F | 20160725 | 20160715 | 20160801 | EXP | BE-MYLANLABS-2016M1029322 | MYLAN | SZTURZ P, SPECENIER P, VAN LAER C, VAN DEN WEYNGAERT D, CORTHOUTS B, CARP L, ET AL. LONG-TERM REMISSION OF LOCALLY RECURRENT OROPHARYNGEAL CANCER AFTER DOCETAXEL-BASED CHEMOTHERAPY PLUS CETUXIMAB. EUR-ARCH-OTORHINOLARYNGOL 2016;273(6):1629-1636. | 0.00 | Y | 0.00000 | 20160801 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125610642 | 12561064 | 1 | SS | DOCETAXEL. | DOCETAXEL | 1 | Unknown | 75 MG/M2 ON DAY 1 | Y | U | 0 | ||||||||
| 125610642 | 12561064 | 2 | PS | CISPLATIN. | CISPLATIN | 1 | Unknown | 75 MG/M2 ON DAY 1 | Y | U | 91062 | ||||||||
| 125610642 | 12561064 | 3 | SS | CISPLATIN. | CISPLATIN | 1 | Unknown | 100 MG/M2 ON DAY 1 | Y | U | 91062 | ||||||||
| 125610642 | 12561064 | 4 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Unknown | 750 MG/M2 ON DAYS 1-5 | Y | U | 0 | ||||||||
| 125610642 | 12561064 | 5 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | 1000 MG/M2 ON DAYS 1-4 | Y | U | 0 | |||||||||
| 125610642 | 12561064 | 6 | SS | CETUXIMAB | CETUXIMAB | 1 | Unknown | 250 MG/M2 ON DAYS 1,8 AND 15 | Y | U | 0 | ||||||||
| 125610642 | 12561064 | 7 | SS | CETUXIMAB | CETUXIMAB | 1 | Unknown | 400 MG/M2 ON DAY 1 (LOADING DOSE) | Y | U | 0 | ||||||||
| 125610642 | 12561064 | 8 | SS | CETUXIMAB | CETUXIMAB | 1 | 250 MG/M2 WEEKLY (MAINTENANCE DOES) | Y | U | 0 | |||||||||
| 125610642 | 12561064 | 9 | SS | CETUXIMAB | CETUXIMAB | 1 | 250 MG/M2 WEEKLY (MAINTENANCE DOSE) | Y | U | 0 | |||||||||
| 125610642 | 12561064 | 10 | SS | CETUXIMAB | CETUXIMAB | 1 | Unknown | 400 MG/M2 ON DAY 1 (LOADING DOSE) | Y | U | 0 | ||||||||
| 125610642 | 12561064 | 11 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 8MG TWICE A DAY FOR 3 DAYS | 0 | ||||||||||
| 125610642 | 12561064 | 12 | C | CIPROFLOXACIN. | CIPROFLOXACIN | 1 | Unknown | 500MG EVERY 12 HOURS ON DAYS 5-15 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125610642 | 12561064 | 1 | Oropharyngeal cancer recurrent |
| 125610642 | 12561064 | 2 | Oropharyngeal cancer recurrent |
| 125610642 | 12561064 | 4 | Oropharyngeal cancer recurrent |
| 125610642 | 12561064 | 6 | Oropharyngeal cancer recurrent |
| 125610642 | 12561064 | 11 | Product used for unknown indication |
| 125610642 | 12561064 | 12 | Antibiotic prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125610642 | 12561064 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125610642 | 12561064 | Alopecia | |
| 125610642 | 12561064 | Constipation | |
| 125610642 | 12561064 | Deafness | |
| 125610642 | 12561064 | Decreased appetite | |
| 125610642 | 12561064 | Diarrhoea | |
| 125610642 | 12561064 | Dizziness | |
| 125610642 | 12561064 | Fatigue | |
| 125610642 | 12561064 | Febrile neutropenia | |
| 125610642 | 12561064 | Hypotension | |
| 125610642 | 12561064 | Infection | |
| 125610642 | 12561064 | Nail disorder | |
| 125610642 | 12561064 | Nausea | |
| 125610642 | 12561064 | Neutropenia | |
| 125610642 | 12561064 | Performance status decreased | |
| 125610642 | 12561064 | Peripheral sensory neuropathy | |
| 125610642 | 12561064 | Punctate keratitis | |
| 125610642 | 12561064 | Rash | |
| 125610642 | 12561064 | Stomatitis | |
| 125610642 | 12561064 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 125610642 | 12561064 | 1 | 20060614 | 20060916 | 0 | |
| 125610642 | 12561064 | 2 | 20060614 | 20060916 | 0 | |
| 125610642 | 12561064 | 3 | 20050509 | 0 | ||
| 125610642 | 12561064 | 4 | 20060614 | 20060916 | 0 | |
| 125610642 | 12561064 | 5 | 20050509 | 0 | ||
| 125610642 | 12561064 | 6 | 20060614 | 20060916 | 0 | |
| 125610642 | 12561064 | 7 | 20050509 | 0 | ||
| 125610642 | 12561064 | 8 | 20050913 | 0 | ||
| 125610642 | 12561064 | 9 | 20050509 | 0 | ||
| 125610642 | 12561064 | 10 | 20060614 | 0 |