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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122317037 | 12231703 | 7 | F | 201510 | 20160711 | 20160401 | 20160715 | EXP | MX-BAYER-2015-404717 | BAYER | 59.00 | YR | A | F | Y | 58.50000 | KG | 20160715 | CN | MX | MX |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122317037 | 12231703 | 1 | PS | NEXAVAR | SORAFENIB | 1 | Oral | 400 MG, BID | 21923 | 400 | MG | FILM-COATED TABLET | BID | ||||||
| 122317037 | 12231703 | 2 | SS | NEXAVAR | SORAFENIB | 1 | Oral | 400 MG IN AM, 200 MG IN PM | 21923 | 600 | MG | FILM-COATED TABLET | |||||||
| 122317037 | 12231703 | 3 | SS | NEXAVAR | SORAFENIB | 1 | Oral | 200 MG, QD | 21923 | 200 | MG | FILM-COATED TABLET | QD | ||||||
| 122317037 | 12231703 | 4 | C | CAPTORIL | CAPTOPRIL | 1 | 0 | ||||||||||||
| 122317037 | 12231703 | 5 | C | PROPRANOLOL | PROPRANOLOLPROPRANOLOL HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 122317037 | 12231703 | 6 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | 0 | ||||||||||||
| 122317037 | 12231703 | 7 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | 0 | ||||||||||||
| 122317037 | 12231703 | 8 | C | VITAMIN B COMPLEX [CYANOCOBALAMIN] | 2 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122317037 | 12231703 | 1 | Hepatocellular carcinoma |
| 122317037 | 12231703 | 2 | Hepatocellular carcinoma |
| 122317037 | 12231703 | 3 | Hepatocellular carcinoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122317037 | 12231703 | HO |
| 122317037 | 12231703 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122317037 | 12231703 | Abdominal discomfort | |
| 122317037 | 12231703 | Abdominal pain upper | |
| 122317037 | 12231703 | Anal incontinence | |
| 122317037 | 12231703 | Arthralgia | |
| 122317037 | 12231703 | Asthenia | |
| 122317037 | 12231703 | Bone pain | |
| 122317037 | 12231703 | Burning sensation | |
| 122317037 | 12231703 | Chest pain | |
| 122317037 | 12231703 | Cough | |
| 122317037 | 12231703 | Decreased appetite | |
| 122317037 | 12231703 | Dehydration | |
| 122317037 | 12231703 | Depressed mood | |
| 122317037 | 12231703 | Diarrhoea | |
| 122317037 | 12231703 | Dizziness | |
| 122317037 | 12231703 | Drug ineffective | |
| 122317037 | 12231703 | Drug intolerance | |
| 122317037 | 12231703 | Dysgeusia | |
| 122317037 | 12231703 | Dyspepsia | |
| 122317037 | 12231703 | Ear pain | |
| 122317037 | 12231703 | Erythema | |
| 122317037 | 12231703 | Faeces discoloured | |
| 122317037 | 12231703 | Fall | |
| 122317037 | 12231703 | Fatigue | |
| 122317037 | 12231703 | Feeling abnormal | |
| 122317037 | 12231703 | Feeling cold | |
| 122317037 | 12231703 | Gastric dilatation | |
| 122317037 | 12231703 | Gastritis | |
| 122317037 | 12231703 | Headache | |
| 122317037 | 12231703 | Hepatic mass | |
| 122317037 | 12231703 | Hypoaesthesia | |
| 122317037 | 12231703 | Immunodeficiency | |
| 122317037 | 12231703 | Induration | |
| 122317037 | 12231703 | Insomnia | |
| 122317037 | 12231703 | Irritability | |
| 122317037 | 12231703 | Jaw disorder | |
| 122317037 | 12231703 | Laziness | |
| 122317037 | 12231703 | Limb discomfort | |
| 122317037 | 12231703 | Liver disorder | |
| 122317037 | 12231703 | Local swelling | |
| 122317037 | 12231703 | Mastication disorder | |
| 122317037 | 12231703 | Memory impairment | |
| 122317037 | 12231703 | Muscle spasms | |
| 122317037 | 12231703 | Musculoskeletal disorder | |
| 122317037 | 12231703 | Nail discolouration | |
| 122317037 | 12231703 | Nasopharyngitis | |
| 122317037 | 12231703 | Neoplasm progression | |
| 122317037 | 12231703 | Oesophageal pain | |
| 122317037 | 12231703 | Off label use | |
| 122317037 | 12231703 | Pain | |
| 122317037 | 12231703 | Pain in extremity | |
| 122317037 | 12231703 | Palmar-plantar erythrodysaesthesia syndrome | |
| 122317037 | 12231703 | Peripheral swelling | |
| 122317037 | 12231703 | Platelet count decreased | |
| 122317037 | 12231703 | Product use issue | |
| 122317037 | 12231703 | Pruritus | |
| 122317037 | 12231703 | Pulmonary pain | |
| 122317037 | 12231703 | Salivary hypersecretion | |
| 122317037 | 12231703 | Skin fissures | |
| 122317037 | 12231703 | Skin induration | |
| 122317037 | 12231703 | Skin lesion | |
| 122317037 | 12231703 | Stomatitis | |
| 122317037 | 12231703 | Suicidal ideation | |
| 122317037 | 12231703 | Therapy cessation | |
| 122317037 | 12231703 | Thirst | |
| 122317037 | 12231703 | Transfusion | |
| 122317037 | 12231703 | Trismus | |
| 122317037 | 12231703 | Urinary retention | |
| 122317037 | 12231703 | Uterine haemorrhage | |
| 122317037 | 12231703 | 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 |
|---|---|---|---|---|---|---|
| 122317037 | 12231703 | 1 | 20150823 | 0 | ||
| 122317037 | 12231703 | 2 | 2015 | 0 | ||
| 122317037 | 12231703 | 3 | 201604 | 0 |