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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125759401 | 12575940 | 1 | I | 20160712 | 20160720 | 20160720 | EXP | PHHY2016BE098629 | SANDOZ | 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. EUROPEAN ARCHIVES OF OTO-RHINO-LARYNGOLOGY. 2016;273 (6):1629-36 | 57.00 | YR | M | Y | 0.00000 | 20160720 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125759401 | 12575940 | 1 | SS | CISPLATIN. | CISPLATIN | 1 | Unknown | 75 MG/M2, UNK (ON DAY 1) | N | 0 | 75 | MG/M**2 | |||||||
| 125759401 | 12575940 | 2 | PS | DOCETAXEL. | DOCETAXEL | 1 | Unknown | 75 MG/M2, UNK (ON DAY 1) | N | 201525 | 75 | MG/M**2 | |||||||
| 125759401 | 12575940 | 3 | SS | 5 FLUORO URACIL | FLUOROURACIL | 1 | Unknown | 750 MG/M2, UNK (ON DAYS 1?5) | N | 0 | 750 | MG/M**2 | |||||||
| 125759401 | 12575940 | 4 | I | CETUXIMAB | CETUXIMAB | 1 | Unknown | 250 MG/M2, UNK (ON DAYS 1, 8, AND 15) | N | 0 | 250 | MG/M**2 | |||||||
| 125759401 | 12575940 | 5 | I | CETUXIMAB | CETUXIMAB | 1 | Unknown | 250 MG/M2, UNK | N | 0 | 250 | MG/M**2 | |||||||
| 125759401 | 12575940 | 6 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 8 MG, BID (FOR 3 DAYS) | U | 0 | 8 | MG | BID | ||||||
| 125759401 | 12575940 | 7 | C | CIPROFLOXACIN. | CIPROFLOXACIN | 1 | Unknown | 500 MG, Q12H (ON DAYS 5 TO 15) | U | 0 | 500 | MG | Q12H |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125759401 | 12575940 | 1 | Squamous cell carcinoma of head and neck |
| 125759401 | 12575940 | 2 | Squamous cell carcinoma of head and neck |
| 125759401 | 12575940 | 3 | Squamous cell carcinoma of head and neck |
| 125759401 | 12575940 | 4 | Squamous cell carcinoma of head and neck |
| 125759401 | 12575940 | 6 | Premedication |
| 125759401 | 12575940 | 7 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125759401 | 12575940 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125759401 | 12575940 | Alopecia | |
| 125759401 | 12575940 | Deafness | |
| 125759401 | 12575940 | Decreased appetite | |
| 125759401 | 12575940 | Diarrhoea | |
| 125759401 | 12575940 | Dizziness | |
| 125759401 | 12575940 | Drug interaction | |
| 125759401 | 12575940 | Fatigue | |
| 125759401 | 12575940 | Febrile neutropenia | |
| 125759401 | 12575940 | Hypotension | |
| 125759401 | 12575940 | Infection | |
| 125759401 | 12575940 | Nausea | |
| 125759401 | 12575940 | Peripheral sensory neuropathy | |
| 125759401 | 12575940 | Rash | |
| 125759401 | 12575940 | Weight decreased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |