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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 96846773 | 9684677 | 3 | F | 20160712 | 20131112 | 20160715 | EXP | US-ROCHE-1212708 | ROCHE | 0.00 | F | Y | 0.00000 | 20160715 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 96846773 | 9684677 | 1 | PS | ZELBORAF | VEMURAFENIB | 1 | Oral | Y | M1049E1 | 202429 | 960 | MG | TABLET | Q12H | |||||
| 96846773 | 9684677 | 2 | SS | ZELBORAF | VEMURAFENIB | 1 | Oral | Y | M1049E1 | 202429 | 720 | MG | BID | ||||||
| 96846773 | 9684677 | 3 | SS | ZELBORAF | VEMURAFENIB | 1 | Oral | TWO TABLETS IN THE MORNING AND TWO IN THE EVENING | Y | M1049E1 | 202429 | 240 | MG | TABLET | QID | ||||
| 96846773 | 9684677 | 4 | SS | ZELBORAF | VEMURAFENIB | 1 | Oral | FOUR IN THE MORNING AND FOUR IN THE EVENING | Y | M1049E1 | 202429 | ||||||||
| 96846773 | 9684677 | 5 | SS | ZELBORAF | VEMURAFENIB | 1 | Oral | 2 TAB (480MG) ORAL TWICE A DAY | Y | M1049E1 | 202429 | 480 | MG | TABLET | BID | ||||
| 96846773 | 9684677 | 6 | SS | LUCENTIS | RANIBIZUMAB | 1 | Other | U | UNK | 125156 | .05 | MG | /month | ||||||
| 96846773 | 9684677 | 7 | SS | LUCENTIS | RANIBIZUMAB | 1 | U | UNK | 125156 | ||||||||||
| 96846773 | 9684677 | 8 | C | MOTRIN | IBUPROFEN | 1 | Oral | 0 | TABLET | ||||||||||
| 96846773 | 9684677 | 9 | C | ADVIL | IBUPROFEN | 1 | Oral | UNK | 0 | ||||||||||
| 96846773 | 9684677 | 10 | C | PEPCID | FAMOTIDINE | 1 | Oral | AS REQUIRED | UNK | 0 | 20 | MG | |||||||
| 96846773 | 9684677 | 11 | C | LOMOTIL (UNITED STATES) | 2 | Oral | UNK | 0 | 2.5 | MG | |||||||||
| 96846773 | 9684677 | 12 | C | NEXAVAR | SORAFENIB | 1 | 0 | ||||||||||||
| 96846773 | 9684677 | 13 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Unknown | 0 | .112 | MG | |||||||||
| 96846773 | 9684677 | 14 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | 0 | ||||||||||||
| 96846773 | 9684677 | 15 | C | ALPHAGAN P | BRIMONIDINE TARTRATE | 1 | Ophthalmic | 0 | |||||||||||
| 96846773 | 9684677 | 16 | C | POTASSIUM CHLORIDE. | POTASSIUM CHLORIDE | 1 | Oral | 0 | 20 | MG | |||||||||
| 96846773 | 9684677 | 17 | C | HYDROCHLOROTHIAZIDE. | HYDROCHLOROTHIAZIDE | 1 | Oral | 0 | 25 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 96846773 | 9684677 | 1 | Malignant melanoma |
| 96846773 | 9684677 | 2 | Metastases to lung |
| 96846773 | 9684677 | 6 | Retinal vein occlusion |
| 96846773 | 9684677 | 7 | Venous occlusion |
| 96846773 | 9684677 | 8 | Pyrexia |
| 96846773 | 9684677 | 9 | Pyrexia |
| 96846773 | 9684677 | 10 | Dyspepsia |
| 96846773 | 9684677 | 11 | Diarrhoea |
| 96846773 | 9684677 | 13 | Hypothyroidism |
| 96846773 | 9684677 | 14 | Hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 96846773 | 9684677 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 96846773 | 9684677 | Abdominal discomfort | |
| 96846773 | 9684677 | Abdominal distension | |
| 96846773 | 9684677 | Blister | |
| 96846773 | 9684677 | Decreased appetite | |
| 96846773 | 9684677 | Dehydration | |
| 96846773 | 9684677 | Diarrhoea | |
| 96846773 | 9684677 | Dyspepsia | |
| 96846773 | 9684677 | Flatulence | |
| 96846773 | 9684677 | Flushing | |
| 96846773 | 9684677 | Nausea | |
| 96846773 | 9684677 | Ocular hyperaemia | |
| 96846773 | 9684677 | Paraesthesia | |
| 96846773 | 9684677 | Peripheral swelling | |
| 96846773 | 9684677 | Pyrexia | |
| 96846773 | 9684677 | Retinal vein occlusion | |
| 96846773 | 9684677 | Venous occlusion | |
| 96846773 | 9684677 | Vision blurred | |
| 96846773 | 9684677 | Vitreous floaters |
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 |
|---|---|---|---|---|---|---|
| 96846773 | 9684677 | 1 | 20120211 | 0 | ||
| 96846773 | 9684677 | 6 | 20120612 | 20130327 | 0 |