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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127138881 | 12713888 | 1 | I | 20160115 | 20160429 | 20160905 | 20160905 | EXP | US-ROCHE-1750284 | ROCHE | 51.00 | YR | M | Y | 70.40000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127138881 | 12713888 | 1 | PS | Bevacizumab | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | 28/DEC/2015, LAST DOSE PRIOR TO SAE?04/DEC/2015 CYCLE 3 (TOTAL DOSE RECEIVED: 1055 MG)?28/DEC/2015 C | U | 125085 | 15 | MG/KG | Q3W | ||||||
| 127138881 | 12713888 | 2 | SS | Ipilimumab | IPILIMUMAB | 1 | Intravenous (not otherwise specified) | 28/DEC/2015, LAST DOSE PRIOR TO SAE?04/DEC/2015 CYCLE 3 (TOTAL DOSE RECEIVED: 211 MG)?28/DEC/2015 CY | 0 | 3 | MG/KG | Q3W | |||||||
| 127138881 | 12713888 | 3 | SS | HYDROCHLOROTHIAZIDE. | HYDROCHLOROTHIAZIDE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127138881 | 12713888 | 1 | Malignant melanoma |
| 127138881 | 12713888 | 2 | Malignant melanoma |
| 127138881 | 12713888 | 3 | Malignant melanoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127138881 | 12713888 | OT |
| 127138881 | 12713888 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127138881 | 12713888 | Adrenal insufficiency | |
| 127138881 | 12713888 | Dehydration | |
| 127138881 | 12713888 | Fatigue | |
| 127138881 | 12713888 | Gait disturbance | |
| 127138881 | 12713888 | Hypertension | |
| 127138881 | 12713888 | Hypokalaemia | |
| 127138881 | 12713888 | Hyponatraemia | |
| 127138881 | 12713888 | Hypophosphataemia | |
| 127138881 | 12713888 | Lipase increased | |
| 127138881 | 12713888 | Metabolic disorder | |
| 127138881 | 12713888 | Muscular weakness |
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 |
|---|---|---|---|---|---|---|
| 127138881 | 12713888 | 1 | 20151028 | 0 | ||
| 127138881 | 12713888 | 2 | 20151023 | 0 |