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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125783832 | 12578383 | 2 | F | 20160316 | 20160801 | 20160721 | 20160810 | EXP | JP-BRISTOL-MYERS SQUIBB COMPANY-BMS-2016-023481 | BRISTOL MYERS SQUIBB | 66.00 | YR | M | Y | 0.00000 | 20160810 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125783832 | 12578383 | 1 | PS | NIVOLUMAB | NIVOLUMAB | 1 | Intravenous drip | 3 MG/KG, Q2WK | 6 | MG/KG | Y | 125554 | 3 | MG/KG | SOLUTION FOR INJECTION | QOW | |||
| 125783832 | 12578383 | 2 | SS | NIVOLUMAB | NIVOLUMAB | 1 | Intravenous drip | 3 MG/KG, Q2WK | 6 | MG/KG | Y | 125554 | 3 | MG/KG | SOLUTION FOR INJECTION | QOW | |||
| 125783832 | 12578383 | 3 | SS | NIVOLUMAB | NIVOLUMAB | 1 | Intravenous drip | 3 MG/KG, UNK | 6 | MG/KG | Y | 125554 | 3 | MG/KG | SOLUTION FOR INJECTION | ||||
| 125783832 | 12578383 | 4 | SS | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | Unknown | U | 0 | ||||||||||
| 125783832 | 12578383 | 5 | SS | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125783832 | 12578383 | 1 | Non-small cell lung cancer |
| 125783832 | 12578383 | 4 | Product used for unknown indication |
| 125783832 | 12578383 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125783832 | 12578383 | HO |
| 125783832 | 12578383 | DE |
| 125783832 | 12578383 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125783832 | 12578383 | Colitis | |
| 125783832 | 12578383 | Cytomegalovirus infection | |
| 125783832 | 12578383 | Diarrhoea | |
| 125783832 | 12578383 | Disseminated intravascular coagulation | |
| 125783832 | 12578383 | Hepatic function abnormal | |
| 125783832 | 12578383 | Pneumocystis jirovecii pneumonia | |
| 125783832 | 12578383 | Renal impairment | |
| 125783832 | 12578383 | Systemic candida | |
| 125783832 | 12578383 | Transfusion |
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 |
|---|---|---|---|---|---|---|
| 125783832 | 12578383 | 1 | 20160205 | 20160205 | 0 | |
| 125783832 | 12578383 | 2 | 20160222 | 20160222 | 0 | |
| 125783832 | 12578383 | 3 | 20160307 | 20160307 | 0 |