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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126516851 | 12651685 | 1 | I | 20160418 | 20160803 | 20160815 | 20160815 | EXP | JP-JNJFOC-20160807155 | JANSSEN | 69.17 | YR | E | F | Y | 39.00000 | KG | 20160815 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126516851 | 12651685 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | U | U | 0 | 200 | MG | LYOPHILIZED POWDER | ||||||
| 126516851 | 12651685 | 2 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | U | U | 103772 | 400 | MG | LYOPHILIZED POWDER | ||||||
| 126516851 | 12651685 | 3 | SS | YERVOY | IPILIMUMAB | 1 | Intravenous drip | U | 0 | 3 | MG/KG | UNSPECIFIED | |||||||
| 126516851 | 12651685 | 4 | SS | YERVOY | IPILIMUMAB | 1 | Intravenous drip | U | 0 | 3 | MG/KG | UNSPECIFIED | |||||||
| 126516851 | 12651685 | 5 | SS | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Oral | U | 0 | 15 | MG | UNSPECIFIED | |||||||
| 126516851 | 12651685 | 6 | SS | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Oral | U | 0 | 40 | MG | UNSPECIFIED | |||||||
| 126516851 | 12651685 | 7 | SS | PREDNISOLONE SODIUM SUCCINATE | PREDNISOLONE SODIUM SUCCINATE | 1 | Intravenous (not otherwise specified) | U | 0 | 40 | MG | UNSPECIFIED | |||||||
| 126516851 | 12651685 | 8 | SS | PREDNISOLONE SODIUM SUCCINATE | PREDNISOLONE SODIUM SUCCINATE | 1 | Intravenous (not otherwise specified) | U | 0 | 30 | MG | UNSPECIFIED | |||||||
| 126516851 | 12651685 | 9 | SS | PREDNISOLONE SODIUM SUCCINATE | PREDNISOLONE SODIUM SUCCINATE | 1 | Intravenous (not otherwise specified) | U | 0 | 50 | MG | UNSPECIFIED | |||||||
| 126516851 | 12651685 | 10 | SS | PREDNISOLONE SODIUM SUCCINATE | PREDNISOLONE SODIUM SUCCINATE | 1 | Intravenous (not otherwise specified) | U | 0 | 60 | MG | UNSPECIFIED | |||||||
| 126516851 | 12651685 | 11 | C | OXYCONTIN | OXYCODONE HYDROCHLORIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 126516851 | 12651685 | 12 | C | OXINORM | OXYCODONE HYDROCHLORIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 126516851 | 12651685 | 13 | C | CELECOX | CELECOXIB | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 126516851 | 12651685 | 14 | C | COCARL | ACETAMINOPHEN | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 126516851 | 12651685 | 15 | C | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | Oral | 0 | UNSPECIFIED | ||||||||||
| 126516851 | 12651685 | 16 | C | PITAVASTATIN | PITAVASTATIN | 1 | Oral | 0 | UNSPECIFIED | ||||||||||
| 126516851 | 12651685 | 17 | C | MAGLAX | MAGNESIUM OXIDE | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126516851 | 12651685 | 1 | Product used for unknown indication |
| 126516851 | 12651685 | 2 | Product used for unknown indication |
| 126516851 | 12651685 | 3 | Malignant melanoma |
| 126516851 | 12651685 | 4 | Malignant melanoma |
| 126516851 | 12651685 | 5 | Product used for unknown indication |
| 126516851 | 12651685 | 6 | Product used for unknown indication |
| 126516851 | 12651685 | 7 | Product used for unknown indication |
| 126516851 | 12651685 | 8 | Product used for unknown indication |
| 126516851 | 12651685 | 9 | Product used for unknown indication |
| 126516851 | 12651685 | 10 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126516851 | 12651685 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126516851 | 12651685 | Diarrhoea | |
| 126516851 | 12651685 | Pyrexia | |
| 126516851 | 12651685 | Sepsis |
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 |
|---|---|---|---|---|---|---|
| 126516851 | 12651685 | 1 | 20160331 | 20160331 | 0 | |
| 126516851 | 12651685 | 2 | 20160413 | 20160413 | 0 | |
| 126516851 | 12651685 | 3 | 20160229 | 20160229 | 0 | |
| 126516851 | 12651685 | 4 | 20160206 | 20160206 | 0 | |
| 126516851 | 12651685 | 6 | 20160325 | 20160328 | 0 | |
| 126516851 | 12651685 | 7 | 20160428 | 0 | ||
| 126516851 | 12651685 | 8 | 20160507 | 0 | ||
| 126516851 | 12651685 | 9 | 20160406 | 0 | ||
| 126516851 | 12651685 | 10 | 20160328 | 0 |