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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116398466 | 11639846 | 6 | F | 2015 | 20160825 | 20151019 | 20160831 | PER | US-EISAI MEDICAL RESEARCH-EC-2015-010809 | EISAI | 64.37 | YR | M | Y | 96.20000 | KG | 20160831 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116398466 | 11639846 | 1 | PS | LENVIMA | LENVATINIB | 1 | Oral | Y | N | L16131 | 206947 | 24 | MG | CAPSULE | QD | ||||
| 116398466 | 11639846 | 2 | SS | LENVIMA | LENVATINIB | 1 | Oral | Y | N | L16131 | 206947 | 24 | MG | CAPSULE | QD | ||||
| 116398466 | 11639846 | 3 | SS | AVAPRO | IRBESARTAN | 1 | Oral | DOSE UNKNOWN | Y | 0 | TABLET | ||||||||
| 116398466 | 11639846 | 4 | C | PROMETHAZINE-CODEINE SYRUP | 2 | 0 | |||||||||||||
| 116398466 | 11639846 | 5 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | 0 | ||||||||||||
| 116398466 | 11639846 | 6 | C | FLOMAX | TAMSULOSIN HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 116398466 | 11639846 | 7 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | 0 | ||||||||||||
| 116398466 | 11639846 | 8 | C | METAXALONE. | METAXALONE | 1 | 0 | ||||||||||||
| 116398466 | 11639846 | 9 | C | LIDOCAINE. | LIDOCAINE | 1 | 0 | ||||||||||||
| 116398466 | 11639846 | 10 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | 0 | ||||||||||||
| 116398466 | 11639846 | 11 | C | PREDNISONE. | PREDNISONE | 1 | 0 | ||||||||||||
| 116398466 | 11639846 | 12 | C | FAMOTIDINE. | FAMOTIDINE | 1 | 0 | ||||||||||||
| 116398466 | 11639846 | 13 | C | TOPROL XL | METOPROLOL SUCCINATE | 1 | 0 | ||||||||||||
| 116398466 | 11639846 | 14 | C | IMODIUM | LOPERAMIDE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 116398466 | 11639846 | 15 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 116398466 | 11639846 | 16 | C | PRAVASTATIN. | PRAVASTATIN | 1 | 0 | ||||||||||||
| 116398466 | 11639846 | 17 | C | IRBESARTAN. | IRBESARTAN | 1 | 0 | ||||||||||||
| 116398466 | 11639846 | 18 | C | VIAGRA | SILDENAFIL CITRATE | 1 | 0 | ||||||||||||
| 116398466 | 11639846 | 19 | C | LABETALOL | LABETALOLLABETALOL HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 116398466 | 11639846 | 20 | C | AMOXICILLIN. | AMOXICILLIN | 1 | 0 | ||||||||||||
| 116398466 | 11639846 | 21 | C | HYDROCODONE-ACETAMINOPHEN | ACETAMINOPHENHYDROCODONE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116398466 | 11639846 | 1 | Thyroid cancer |
| 116398466 | 11639846 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116398466 | 11639846 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116398466 | 11639846 | Alopecia | |
| 116398466 | 11639846 | Central nervous system lesion | |
| 116398466 | 11639846 | Decreased appetite | |
| 116398466 | 11639846 | Diarrhoea | |
| 116398466 | 11639846 | Dizziness | |
| 116398466 | 11639846 | Dry skin | |
| 116398466 | 11639846 | Dysphonia | |
| 116398466 | 11639846 | Fatigue | |
| 116398466 | 11639846 | Hypertension | |
| 116398466 | 11639846 | Hypoaesthesia oral | |
| 116398466 | 11639846 | Lip swelling | |
| 116398466 | 11639846 | Nausea | |
| 116398466 | 11639846 | Temperature intolerance | |
| 116398466 | 11639846 | Tongue blistering | |
| 116398466 | 11639846 | Tongue discolouration | |
| 116398466 | 11639846 | Vomiting | |
| 116398466 | 11639846 | 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 |
|---|---|---|---|---|---|---|
| 116398466 | 11639846 | 1 | 20150909 | 20151026 | 0 | |
| 116398466 | 11639846 | 2 | 2015 | 201608 | 0 |