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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122709008 | 12270900 | 8 | F | 2016 | 20160701 | 20160415 | 20160707 | EXP | US-BAYER-2016-066069 | BAYER | 64.00 | YR | A | M | Y | 99.32000 | KG | 20160707 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122709008 | 12270900 | 1 | PS | NEXAVAR | SORAFENIB | 1 | Oral | 400 MG, BID | 21923 | 400 | MG | FILM-COATED TABLET | BID | ||||||
| 122709008 | 12270900 | 2 | C | LORAZEPAM. | LORAZEPAM | 1 | Oral | 1 MG, TID AS NEEDED | 0 | 1 | MG | TABLET | TID | ||||||
| 122709008 | 12270900 | 3 | C | CALCIUM ASCORBATE | CALCIUM ASCORBATE | 1 | Oral | 500 MG, QD | 0 | 500 | MG | TABLET | QD | ||||||
| 122709008 | 12270900 | 4 | C | ATENOLOL. | ATENOLOL | 1 | Oral | 50 MG, QD | 0 | 50 | MG | TABLET | QD | ||||||
| 122709008 | 12270900 | 5 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Oral | 1000 MG, BID | 0 | 1000 | MG | TABLET | BID | ||||||
| 122709008 | 12270900 | 6 | C | VITAMIN B COMPLEX | CYANOCOBALAMINDEXPANTHENOLNIACINAMIDEPYRIDOXINE HYDROCHLORIDERIBOFLAVIN 5'-PHOSPHATE SODIUMTHIAMINE HYDROCHLORIDEVITAMIN B COMPLEX | 1 | Oral | 0 | TABLET | QD | |||||||||
| 122709008 | 12270900 | 7 | C | GLIMEPIRIDE. | GLIMEPIRIDE | 1 | Oral | 4 MG, BID | 0 | 4 | MG | TABLET | BID | ||||||
| 122709008 | 12270900 | 8 | C | LISINOPRIL. | LISINOPRIL | 1 | Oral | 0 | TABLET | ||||||||||
| 122709008 | 12270900 | 9 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Oral | 50 MCG/24HR, UNK | 0 | ||||||||||
| 122709008 | 12270900 | 10 | C | TRIAZOLAM. | TRIAZOLAM | 1 | Oral | 0.25 MG, QD | 0 | .25 | MG | QD | |||||||
| 122709008 | 12270900 | 11 | C | LOPERAMIDE | LOPERAMIDE | 1 | Oral | 8 MG DAILY | 0 | ||||||||||
| 122709008 | 12270900 | 12 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | 40 MG DAILY | 0 | 40 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122709008 | 12270900 | 1 | Hepatocellular carcinoma |
| 122709008 | 12270900 | 2 | Anxiety |
| 122709008 | 12270900 | 10 | Insomnia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122709008 | 12270900 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122709008 | 12270900 | Abdominal discomfort | |
| 122709008 | 12270900 | Abdominal distension | |
| 122709008 | 12270900 | Activities of daily living impaired | |
| 122709008 | 12270900 | Arthralgia | |
| 122709008 | 12270900 | Back pain | |
| 122709008 | 12270900 | Blood glucose increased | |
| 122709008 | 12270900 | Constipation | |
| 122709008 | 12270900 | Decreased appetite | |
| 122709008 | 12270900 | Diarrhoea | |
| 122709008 | 12270900 | Drug dose omission | |
| 122709008 | 12270900 | Fatigue | |
| 122709008 | 12270900 | Flatulence | |
| 122709008 | 12270900 | Heart rate increased | |
| 122709008 | 12270900 | Hepatomegaly | |
| 122709008 | 12270900 | Muscle atrophy | |
| 122709008 | 12270900 | Nausea | |
| 122709008 | 12270900 | Pain | |
| 122709008 | 12270900 | Pyrexia | |
| 122709008 | 12270900 | Self-induced vomiting | |
| 122709008 | 12270900 | Vomiting | |
| 122709008 | 12270900 | 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 |
|---|---|---|---|---|---|---|
| 122709008 | 12270900 | 1 | 20160329 | 0 |