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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116414665 | 11641466 | 5 | F | 20160627 | 20151019 | 20160705 | EXP | US-BAYER-2015-441324 | BAYER | 62.00 | YR | A | F | Y | 0.00000 | 20160705 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116414665 | 11641466 | 1 | PS | NEXAVAR | SORAFENIB | 1 | Oral | 200 MG ALTERNATING WITH 400MG (EVERY OTHER DAY) | 21923 | FILM-COATED TABLET | |||||||||
| 116414665 | 11641466 | 2 | SS | NEXAVAR | SORAFENIB | 1 | Oral | 200 MG ALTERNATING WITH 600 MG (EVERY OTHER DAY) | 21923 | FILM-COATED TABLET | |||||||||
| 116414665 | 11641466 | 3 | SS | NEXAVAR | SORAFENIB | 1 | Oral | 400MG IN AM AND 200MG IN PM | 21923 | 600 | MG | FILM-COATED TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116414665 | 11641466 | 1 | Erdheim-Chester disease |
| 116414665 | 11641466 | 2 | Malignant histiocytosis |
| 116414665 | 11641466 | 3 | Erdheim-Chester disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116414665 | 11641466 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116414665 | 11641466 | Acne | |
| 116414665 | 11641466 | Blister | |
| 116414665 | 11641466 | Contusion | |
| 116414665 | 11641466 | Corneal bleeding | |
| 116414665 | 11641466 | Cough | |
| 116414665 | 11641466 | Dizziness | |
| 116414665 | 11641466 | Gastrointestinal injury | |
| 116414665 | 11641466 | Gastrooesophageal reflux disease | |
| 116414665 | 11641466 | Hair texture abnormal | |
| 116414665 | 11641466 | Hypertension | |
| 116414665 | 11641466 | Macular oedema | |
| 116414665 | 11641466 | Off label use | |
| 116414665 | 11641466 | Rash | |
| 116414665 | 11641466 | Respiratory tract congestion | |
| 116414665 | 11641466 | Skin lesion |
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 |
|---|---|---|---|---|---|---|
| 116414665 | 11641466 | 3 | 20150113 | 0 |