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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125445513 | 12544551 | 3 | F | 201606 | 20160722 | 20160711 | 20160804 | EXP | GB-TEVA-670180ACC | TEVA | 53.67 | YR | M | Y | 83.00000 | KG | 20160804 | MD | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125445513 | 12544551 | 1 | PS | CISPLATIN. | CISPLATIN | 1 | Intravenous (not otherwise specified) | COMPLETED SEVERAL WEEKS AGO | Y | U | 16A07KA,14K18MB,15K24KJ | 74656 | 100 | MG | SOLUTION FOR INJECTION | /wk | |||
| 125445513 | 12544551 | 2 | SS | CISPLATIN. | CISPLATIN | 1 | Intravenous (not otherwise specified) | 14.2857 MILLIGRAM DAILY; COMPLETED SEVERAL WEEKS AGO? | Y | U | 16A07KA,14K18MB,15K24KJ | 74656 | 100 | MG | SOLUTION FOR INJECTION | /wk | |||
| 125445513 | 12544551 | 3 | SS | CISPLATIN. | CISPLATIN | 1 | Intravenous (not otherwise specified) | 14.2857 MILLIGRAM DAILY; COMPLETED SEVERAL WEEKS AGO | Y | U | 16A07KA,14K18MB,15K24KJ | 74656 | 100 | MG | SOLUTION FOR INJECTION | /wk | |||
| 125445513 | 12544551 | 4 | C | FUROSEMIDE. | FUROSEMIDE | 1 | Oral | 0 | 40 | MG | /wk | ||||||||
| 125445513 | 12544551 | 5 | C | Ondansetron | ONDANSETRON | 1 | Oral | 16 MILLIGRAM DAILY; | 0 | 8 | MG | BID | |||||||
| 125445513 | 12544551 | 6 | C | Ondansetron | ONDANSETRON | 1 | Intravenous (not otherwise specified) | 2 DAYS POST CHEMO? | 0 | 8 | MG | /wk | |||||||
| 125445513 | 12544551 | 7 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 8 MILLIGRAM DAILY; | 0 | 4 | MG | BID | |||||||
| 125445513 | 12544551 | 8 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Intravenous (not otherwise specified) | 0 | 6.6 | MG | /wk | ||||||||
| 125445513 | 12544551 | 9 | C | Sodium Chloride 0.9% | SODIUM CHLORIDE | 1 | Intravenous (not otherwise specified) | 0 | 1000 | ML | /wk | ||||||||
| 125445513 | 12544551 | 10 | C | MAGNESIUM SULFATE. | MAGNESIUM SULFATE | 1 | Intravenous (not otherwise specified) | 8MMOL MAGNESIUM SULPHATE, 1000ML WITH CISPLATIN, 1000ML POST CISPLATIN, FOR HYDRATION FLUID | 0 | ||||||||||
| 125445513 | 12544551 | 11 | C | POTASSIUM | POTASSIUM | 1 | Intravenous (not otherwise specified) | 20MML POTASSIUM, 1000ML WITH CISPLATIN, 1000ML POST CISPLATIN? | 0 | ||||||||||
| 125445513 | 12544551 | 12 | C | SODIUM CHLORIDE. | SODIUM CHLORIDE | 1 | 1000ML WITH CISPLATIN, 1000ML POST CISPLATIN | 0 | 1000 | ML |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125445513 | 12544551 | 1 | Tongue neoplasm malignant stage unspecified |
| 125445513 | 12544551 | 4 | Chemotherapy |
| 125445513 | 12544551 | 5 | Vomiting |
| 125445513 | 12544551 | 7 | Vomiting |
| 125445513 | 12544551 | 9 | Dehydration |
| 125445513 | 12544551 | 10 | Dehydration |
| 125445513 | 12544551 | 11 | Dehydration |
| 125445513 | 12544551 | 12 | Dehydration |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125445513 | 12544551 | OT |
| 125445513 | 12544551 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125445513 | 12544551 | Body temperature increased | |
| 125445513 | 12544551 | Hypophagia | |
| 125445513 | 12544551 | Infection | |
| 125445513 | 12544551 | Malaise | |
| 125445513 | 12544551 | Neutropenic sepsis | |
| 125445513 | 12544551 | Pneumonia aspiration | |
| 125445513 | 12544551 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 125445513 | 12544551 | 1 | 20160509 | 0 | ||
| 125445513 | 12544551 | 2 | 20160523 | 0 | ||
| 125445513 | 12544551 | 4 | 20160509 | 20160623 | 0 | |
| 125445513 | 12544551 | 5 | 20160509 | 20160623 | 0 | |
| 125445513 | 12544551 | 6 | 20160509 | 20160623 | 0 | |
| 125445513 | 12544551 | 7 | 20160509 | 20160623 | 0 | |
| 125445513 | 12544551 | 8 | 20160509 | 20160623 | 0 | |
| 125445513 | 12544551 | 9 | 20160509 | 20160623 | 0 | |
| 125445513 | 12544551 | 10 | 20160509 | 20160623 | 0 | |
| 125445513 | 12544551 | 11 | 20160509 | 20160623 | 0 | |
| 125445513 | 12544551 | 12 | 20160509 | 20160623 | 0 |