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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114578486 | 11457848 | 6 | F | 20150809 | 20160715 | 20150904 | 20160726 | EXP | US-ROCHE-1624334 | ROCHE | 78.49 | YR | M | Y | 74.20000 | KG | 20160726 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114578486 | 11457848 | 1 | PS | Cobimetinib | COBIMETINIB | 1 | Oral | DAYS 1-21 OF A 28 DAY CYCLE | 1144116 | 206192 | 60 | MG | CAPSULE | QD | |||||
| 114578486 | 11457848 | 2 | SS | Bevacizumab | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | EVERY TWO WEEKS, 4 WEEK (28-DAY) CYCLES | 1148616 | 125085 | 10 | MG/KG | SOLUTION FOR INFUSION | QOW | |||||
| 114578486 | 11457848 | 3 | SS | Vemurafenib | VEMURAFENIB | 1 | Oral | DAYS 1-21 OF 28 DAY CYCLE | 202429 | 960 | MG | BID | |||||||
| 114578486 | 11457848 | 4 | C | ASPIRIN. | ASPIRIN | 1 | Oral | 0 | 81 | MG | QD | ||||||||
| 114578486 | 11457848 | 5 | C | ASPIRIN. | ASPIRIN | 1 | Oral | 0 | 81 | MG | QD | ||||||||
| 114578486 | 11457848 | 6 | C | CLOPIDOGREL | CLOPIDOGREL BISULFATE | 1 | Oral | 0 | 75 | MG | QD | ||||||||
| 114578486 | 11457848 | 7 | C | LEVOCETIRIZINE DIHYDROCHLORIDE. | LEVOCETIRIZINE DIHYDROCHLORIDE | 1 | Oral | 0 | QD | ||||||||||
| 114578486 | 11457848 | 8 | C | FLUTICASONE PROPIONATE. | FLUTICASONE PROPIONATE | 1 | Other | 1 INHALED | 0 | ||||||||||
| 114578486 | 11457848 | 9 | C | LEVOTHYROXINE SODIUM. | LEVOTHYROXINE SODIUM | 1 | Oral | 0 | 75 | UG | QD | ||||||||
| 114578486 | 11457848 | 10 | C | LEVOTHYROXINE SODIUM. | LEVOTHYROXINE SODIUM | 1 | Other | 0 | 37.5 | UG | QD | ||||||||
| 114578486 | 11457848 | 11 | C | LEVOTHYROXINE SODIUM. | LEVOTHYROXINE SODIUM | 1 | Oral | 0 | 75 | UG | QD | ||||||||
| 114578486 | 11457848 | 12 | C | LIPITOR | ATORVASTATIN CALCIUM | 1 | Oral | 0 | |||||||||||
| 114578486 | 11457848 | 13 | C | LISINOPRIL. | LISINOPRIL | 1 | Oral | 0 | |||||||||||
| 114578486 | 11457848 | 14 | C | TAMSULOSIN HCL | TAMSULOSIN | 1 | Oral | 0 | |||||||||||
| 114578486 | 11457848 | 15 | C | TOPROL XL | METOPROLOL SUCCINATE | 1 | Oral | 0 | |||||||||||
| 114578486 | 11457848 | 16 | C | HYDROCORTISON | HYDROCORTISONE | 1 | Oral | 0 | 10 | MG | TID | ||||||||
| 114578486 | 11457848 | 17 | C | HYDROCORTISON | HYDROCORTISONE | 1 | Unknown | IV PUSH | 0 | 50 | MG | Q6H |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114578486 | 11457848 | 1 | Malignant melanoma |
| 114578486 | 11457848 | 2 | Malignant melanoma |
| 114578486 | 11457848 | 3 | Malignant melanoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 114578486 | 11457848 | HO |
| 114578486 | 11457848 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114578486 | 11457848 | Asthenia | |
| 114578486 | 11457848 | Blood creatinine increased | |
| 114578486 | 11457848 | Cholecystitis | |
| 114578486 | 11457848 | Dehydration | |
| 114578486 | 11457848 | Diarrhoea | |
| 114578486 | 11457848 | Fatigue | |
| 114578486 | 11457848 | Hyponatraemia | |
| 114578486 | 11457848 | Hypotension | |
| 114578486 | 11457848 | Mental status changes | |
| 114578486 | 11457848 | Multiple organ dysfunction syndrome | |
| 114578486 | 11457848 | Muscle haemorrhage | |
| 114578486 | 11457848 | Pyrexia | |
| 114578486 | 11457848 | Renal impairment | |
| 114578486 | 11457848 | Respiratory failure | |
| 114578486 | 11457848 | Retroperitoneal haemorrhage |
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 |
|---|---|---|---|---|---|---|
| 114578486 | 11457848 | 1 | 20150730 | 20150808 | 0 | |
| 114578486 | 11457848 | 2 | 20150730 | 0 | ||
| 114578486 | 11457848 | 3 | 20150730 | 20150808 | 0 | |
| 114578486 | 11457848 | 4 | 20060805 | 0 | ||
| 114578486 | 11457848 | 5 | 20150812 | 20150816 | 0 | |
| 114578486 | 11457848 | 6 | 20060805 | 20150816 | 0 | |
| 114578486 | 11457848 | 7 | 201403 | 0 | ||
| 114578486 | 11457848 | 8 | 201403 | 0 | ||
| 114578486 | 11457848 | 10 | 20150816 | 20150817 | 0 | |
| 114578486 | 11457848 | 11 | 20150818 | 20150822 | 0 | |
| 114578486 | 11457848 | 12 | 200605 | 0 | ||
| 114578486 | 11457848 | 13 | 20060805 | 0 | ||
| 114578486 | 11457848 | 14 | 2012 | 0 | ||
| 114578486 | 11457848 | 15 | 200605 | 0 | ||
| 114578486 | 11457848 | 16 | 20150511 | 20150813 | 0 | |
| 114578486 | 11457848 | 17 | 20150813 | 20150814 | 0 |