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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126735111 | 12673511 | 1 | I | 201603 | 20160610 | 20160822 | 20160822 | EXP | US-BAYER-2016-115872 | BAYER | 79.00 | YR | E | M | Y | 0.00000 | 20160822 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126735111 | 12673511 | 1 | PS | NEXAVAR | SORAFENIB | 1 | Oral | 400 MG, BID | 21923 | 400 | MG | FILM-COATED TABLET | BID | ||||||
| 126735111 | 12673511 | 2 | SS | NEXAVAR | SORAFENIB | 1 | Oral | 200 MG, BID | 21923 | 200 | MG | FILM-COATED TABLET | BID | ||||||
| 126735111 | 12673511 | 3 | C | OXYCODONE | OXYCODONE | 1 | 0 | ||||||||||||
| 126735111 | 12673511 | 4 | C | SENOKOT | SENNOSIDES | 1 | 0 | ||||||||||||
| 126735111 | 12673511 | 5 | C | PRILOSEC | OMEPRAZOLE MAGNESIUM | 1 | 0 | ||||||||||||
| 126735111 | 12673511 | 6 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | UNK UNK, BID | 0 | BID | ||||||||||
| 126735111 | 12673511 | 7 | C | NAPROXEN. | NAPROXEN | 1 | 500 MG, BID | 0 | 500 | MG | BID | ||||||||
| 126735111 | 12673511 | 8 | C | NAPROXEN. | NAPROXEN | 1 | 0 | ||||||||||||
| 126735111 | 12673511 | 9 | C | LACTULOSE. | LACTULOSE | 1 | 15 MG, BID | 0 | 15 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126735111 | 12673511 | 1 | Hepatocellular carcinoma |
| 126735111 | 12673511 | 2 | Hepatocellular carcinoma |
| 126735111 | 12673511 | 3 | Pain |
| 126735111 | 12673511 | 4 | Constipation |
| 126735111 | 12673511 | 5 | Gastrooesophageal reflux disease |
| 126735111 | 12673511 | 6 | Oedema |
| 126735111 | 12673511 | 7 | Abdominal pain upper |
| 126735111 | 12673511 | 8 | Night sweats |
| 126735111 | 12673511 | 9 | Constipation |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126735111 | 12673511 | DE |
| 126735111 | 12673511 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126735111 | 12673511 | Abdominal distension | |
| 126735111 | 12673511 | Abdominal pain | |
| 126735111 | 12673511 | Abdominal pain upper | |
| 126735111 | 12673511 | Abdominal tenderness | |
| 126735111 | 12673511 | Back pain | |
| 126735111 | 12673511 | Blood pressure decreased | |
| 126735111 | 12673511 | Breath odour | |
| 126735111 | 12673511 | Chest X-ray abnormal | |
| 126735111 | 12673511 | Death | |
| 126735111 | 12673511 | Dry mouth | |
| 126735111 | 12673511 | Dyspnoea | |
| 126735111 | 12673511 | General physical health deterioration | |
| 126735111 | 12673511 | Heart rate increased | |
| 126735111 | 12673511 | Hepatic cancer | |
| 126735111 | 12673511 | Hepatic encephalopathy | |
| 126735111 | 12673511 | Infrequent bowel movements | |
| 126735111 | 12673511 | Insomnia | |
| 126735111 | 12673511 | Nausea | |
| 126735111 | 12673511 | Neoplasm progression | |
| 126735111 | 12673511 | Oxygen saturation decreased | |
| 126735111 | 12673511 | Penile ulceration | |
| 126735111 | 12673511 | Pleural effusion | |
| 126735111 | 12673511 | Pulmonary physical examination abnormal | |
| 126735111 | 12673511 | Respiratory failure | |
| 126735111 | 12673511 | Stomatitis | |
| 126735111 | 12673511 | Urine output decreased | |
| 126735111 | 12673511 | Vomiting | |
| 126735111 | 12673511 | 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 |
|---|---|---|---|---|---|---|
| 126735111 | 12673511 | 1 | 201603 | 2016 | 0 | |
| 126735111 | 12673511 | 2 | 2016 | 2016 | 0 |