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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127093953 | 12709395 | 3 | F | 20160818 | 20160915 | 20160901 | 20160926 | EXP | US-BAUSCH-BL-2016-020467 | BAUSCH AND LOMB | 76.72 | YR | M | Y | 0.00000 | 20160926 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127093953 | 12709395 | 1 | PS | PROVENGE | SIPULEUCEL-T | 1 | Intravenous (not otherwise specified) | PARTIAL INFUSION | U | 411017-1,411017-2,411017-3 | 125197 | 250 | ML | SUSPENSION | QD | ||||
| 127093953 | 12709395 | 2 | SS | PROVENGE | SIPULEUCEL-T | 1 | Intravenous (not otherwise specified) | U | 411017-1,411017-2,411017-3 | 125197 | 250 | ML | SUSPENSION | QD | |||||
| 127093953 | 12709395 | 3 | SS | PROVENGE | SIPULEUCEL-T | 1 | Intravenous (not otherwise specified) | U | 411017-1,411017-2,411017-3 | 125197 | 250 | ML | SUSPENSION | QD | |||||
| 127093953 | 12709395 | 4 | SS | DEMEROL | MEPERIDINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | U | 0 | ||||||||||
| 127093953 | 12709395 | 5 | C | ASPIRIN. | ASPIRIN | 1 | 0 | ||||||||||||
| 127093953 | 12709395 | 6 | C | CALCIUM | CALCIUM | 1 | 0 | ||||||||||||
| 127093953 | 12709395 | 7 | C | CARVEDILOL. | CARVEDILOL | 1 | 0 | ||||||||||||
| 127093953 | 12709395 | 8 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 127093953 | 12709395 | 9 | C | OMEGA-3 ACIDS | OMEGA-3 FATTY ACIDS | 1 | 0 | ||||||||||||
| 127093953 | 12709395 | 10 | C | POTASSIUM | POTASSIUM | 1 | 0 | ||||||||||||
| 127093953 | 12709395 | 11 | C | VITAMIN C | ASCORBIC ACID | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127093953 | 12709395 | 1 | Prostate cancer |
| 127093953 | 12709395 | 4 | Chills |
| 127093953 | 12709395 | 5 | Product used for unknown indication |
| 127093953 | 12709395 | 6 | Product used for unknown indication |
| 127093953 | 12709395 | 7 | Product used for unknown indication |
| 127093953 | 12709395 | 8 | Product used for unknown indication |
| 127093953 | 12709395 | 9 | Product used for unknown indication |
| 127093953 | 12709395 | 10 | Product used for unknown indication |
| 127093953 | 12709395 | 11 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127093953 | 12709395 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127093953 | 12709395 | Aspiration | |
| 127093953 | 12709395 | Chills | |
| 127093953 | 12709395 | Sedation | |
| 127093953 | 12709395 | 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 |
|---|---|---|---|---|---|---|
| 127093953 | 12709395 | 1 | 20160818 | 20160818 | 0 | |
| 127093953 | 12709395 | 2 | 20160901 | 20160901 | 0 | |
| 127093953 | 12709395 | 3 | 20160915 | 20160915 | 0 |