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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 107434093 | 10743409 | 3 | F | 20141125 | 20160823 | 20150128 | 20160905 | EXP | US-ROCHE-1523563 | ROCHE | 39.00 | YR | M | Y | 102.10000 | KG | 20160905 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 107434093 | 10743409 | 1 | PS | Bevacizumab | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | DOSE 15MG/KG, LAST ADMINISTERED DOSE 09/DEC/2014?DATE OF LAST DOSE PRIOR TO SAE: 30/DEC/2014 | 125085 | 1425 | MG | SOLUTION FOR INFUSION | /cycle | ||||||
| 107434093 | 10743409 | 2 | SS | Bevacizumab | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | DOSE 15MG/KG, LAST ADMINISTERED DOSE 18/NOV/2014, 09/DEC/2014 | 125085 | 1535 | MG | SOLUTION FOR INFUSION | /cycle | ||||||
| 107434093 | 10743409 | 3 | SS | IPILIMUMAB | IPILIMUMAB | 1 | Intravenous (not otherwise specified) | DOSE 3MG/KG, LAST DOSE ADMINISTERED 09/DEC/2014 | 0 | 285 | MG | /cycle | |||||||
| 107434093 | 10743409 | 4 | SS | IPILIMUMAB | IPILIMUMAB | 1 | Intravenous (not otherwise specified) | DOSE 3MG/KG, LAST DOSE ADMINISTERED, 18/NOV/2014, 09/DEC/2014 | 0 | 307 | MG | /cycle | |||||||
| 107434093 | 10743409 | 5 | C | DOCUSATE SODIUM. | DOCUSATE SODIUM | 1 | 0 | ||||||||||||
| 107434093 | 10743409 | 6 | C | AUGMENTIN | AMOXICILLINCLAVULANATE POTASSIUM | 1 | 0 | ||||||||||||
| 107434093 | 10743409 | 7 | C | ONDANSETRON | ONDANSETRON | 1 | 0 | ||||||||||||
| 107434093 | 10743409 | 8 | C | SODIUM CHLORIDE. | SODIUM CHLORIDE | 1 | 0 | ||||||||||||
| 107434093 | 10743409 | 9 | C | LISINOPRIL. | LISINOPRIL | 1 | 0 | ||||||||||||
| 107434093 | 10743409 | 10 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 107434093 | 10743409 | 11 | C | SIMVASTATIN. | SIMVASTATIN | 1 | 0 | ||||||||||||
| 107434093 | 10743409 | 12 | C | ASPIRIN. | ASPIRIN | 1 | 0 | ||||||||||||
| 107434093 | 10743409 | 13 | C | MARIJUANA | CANNABIS SATIVA SUBSP. INDICA TOP | 1 | 0 | ||||||||||||
| 107434093 | 10743409 | 14 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Unknown | 0 | 325 | MG | |||||||||
| 107434093 | 10743409 | 15 | C | TYLENOL | ACETAMINOPHEN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 107434093 | 10743409 | 1 | Malignant melanoma |
| 107434093 | 10743409 | 3 | Malignant melanoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 107434093 | 10743409 | OT |
| 107434093 | 10743409 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 107434093 | 10743409 | Abdominal pain | |
| 107434093 | 10743409 | Encephalopathy | |
| 107434093 | 10743409 | Endocrine disorder | |
| 107434093 | 10743409 | Fatigue | |
| 107434093 | 10743409 | Hyponatraemia | |
| 107434093 | 10743409 | Rash maculo-papular | |
| 107434093 | 10743409 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 107434093 | 10743409 | 1 | 20141028 | 0 | ||
| 107434093 | 10743409 | 2 | 20141209 | 0 | ||
| 107434093 | 10743409 | 3 | 20141028 | 0 | ||
| 107434093 | 10743409 | 4 | 20141209 | 0 |