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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121352443 | 12135244 | 3 | F | 20160210 | 20160802 | 20160301 | 20160809 | EXP | US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2016-012361 | BRISTOL MYERS SQUIBB | 45.00 | YR | F | Y | 0.00000 | 20160809 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121352443 | 12135244 | 1 | PS | IPILIMUMAB | IPILIMUMAB | 1 | Unknown | 3 MG/KG, UNK | U | 125377 | 3 | MG/KG | |||||||
| 121352443 | 12135244 | 2 | SS | IPILIMUMAB | IPILIMUMAB | 1 | Unknown | 3 MG/KG, UNK | U | 125377 | 3 | MG/KG | |||||||
| 121352443 | 12135244 | 3 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | 60 MG/KG, QD | 120 | MG/KG | U | 0 | 60 | MG/KG | QD | ||||
| 121352443 | 12135244 | 4 | SS | FLUDARABINE PHOSPHATE. | FLUDARABINE PHOSPHATE | 1 | Unknown | 25 MG/M2, QD | 125 | MG/M2 | U | 0 | 25 | MG/M**2 | QD | ||||
| 121352443 | 12135244 | 5 | SS | INTERLEUKIN-2 | ALDESLEUKIN | 1 | Unknown | 5 UNK, UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121352443 | 12135244 | 1 | Metastatic malignant melanoma |
| 121352443 | 12135244 | 3 | Metastatic malignant melanoma |
| 121352443 | 12135244 | 4 | Metastatic malignant melanoma |
| 121352443 | 12135244 | 5 | Metastatic malignant melanoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121352443 | 12135244 | OT |
| 121352443 | 12135244 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121352443 | 12135244 | Dyspnoea | |
| 121352443 | 12135244 | Non-cardiac chest pain | |
| 121352443 | 12135244 | Pulmonary embolism | |
| 121352443 | 12135244 | Vascular access complication |
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 |
|---|---|---|---|---|---|---|
| 121352443 | 12135244 | 1 | 20151104 | 0 | ||
| 121352443 | 12135244 | 2 | 20151125 | 0 | ||
| 121352443 | 12135244 | 3 | 20151221 | 20151222 | 0 | |
| 121352443 | 12135244 | 4 | 20151223 | 20151227 | 0 | |
| 121352443 | 12135244 | 5 | 20151229 | 0 |