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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 90687962 | 9068796 | 2 | F | 20160823 | 20130215 | 20160830 | EXP | US-CELGENEUS-163-21660-13021163 | CELGENE | ADKINS D. NAB-PACLITAXEL, CISPLATIN, AND 5-FLUOROURACIL FOLLOWED BY CONCURRENT CISPLATIN AND RADIATION FOR HEAD AND NECK SQUAMOUS CELL CARCINOMA. ORAL ONCOLOGY. 2016;. | 0.00 | Y | 0.00000 | 20160830 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 90687962 | 9068796 | 1 | PS | ABRAXANE | PACLITAXEL | 1 | Intravenous drip | 100 MILLIGRAM/SQ. METER | U | 21660 | 100 | MG/M**2 | INJECTION FOR INFUSION | ||||||
| 90687962 | 9068796 | 2 | SS | CETUXIMAB | CETUXIMAB | 1 | Unknown | U | 0 | 400 | MG/M**2 | UNKNOWN | |||||||
| 90687962 | 9068796 | 3 | SS | CETUXIMAB | CETUXIMAB | 1 | Unknown | U | 0 | 250 | MG/M**2 | UNKNOWN | |||||||
| 90687962 | 9068796 | 4 | SS | CISPLATIN. | CISPLATIN | 1 | Unknown | U | 72883 | 75 | MG/M**2 | UNKNOWN | |||||||
| 90687962 | 9068796 | 5 | SS | CISPLATIN. | CISPLATIN | 1 | Unknown | U | 72883 | 100 | MG/M**2 | UNKNOWN | |||||||
| 90687962 | 9068796 | 6 | SS | 5-fluorouracil | FLUOROURACIL | 1 | Intravenous drip | 750 MILLIGRAM/SQ. METER | U | 0 | 750 | MG/M**2 | LIQUID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 90687962 | 9068796 | 1 | Squamous cell carcinoma of head and neck |
| 90687962 | 9068796 | 2 | Squamous cell carcinoma of head and neck |
| 90687962 | 9068796 | 4 | Squamous cell carcinoma of head and neck |
| 90687962 | 9068796 | 6 | Squamous cell carcinoma of head and neck |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 90687962 | 9068796 | DE |
| 90687962 | 9068796 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 90687962 | 9068796 | Alanine aminotransferase increased | |
| 90687962 | 9068796 | Anaemia | |
| 90687962 | 9068796 | Aspartate aminotransferase increased | |
| 90687962 | 9068796 | Bacterial sepsis | |
| 90687962 | 9068796 | Blood creatinine increased | |
| 90687962 | 9068796 | Chronic hepatitis C | |
| 90687962 | 9068796 | Colitis | |
| 90687962 | 9068796 | Dermatitis acneiform | |
| 90687962 | 9068796 | Diarrhoea | |
| 90687962 | 9068796 | Fatigue | |
| 90687962 | 9068796 | Febrile neutropenia | |
| 90687962 | 9068796 | Hypersensitivity | |
| 90687962 | 9068796 | Hypokalaemia | |
| 90687962 | 9068796 | Infusion site reaction | |
| 90687962 | 9068796 | Mucosal inflammation | |
| 90687962 | 9068796 | Neuropathy peripheral | |
| 90687962 | 9068796 | Neutropenia | |
| 90687962 | 9068796 | Oedema peripheral | |
| 90687962 | 9068796 | Pneumonia | |
| 90687962 | 9068796 | Rash | |
| 90687962 | 9068796 | Squamous cell carcinoma of head and neck | |
| 90687962 | 9068796 | Thrombocytopenia | |
| 90687962 | 9068796 | Thrombosis | |
| 90687962 | 9068796 | Tinnitus | |
| 90687962 | 9068796 | Weight decreased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |