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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126842051 | 12684205 | 1 | I | 20160811 | 20160825 | 20160825 | EXP | US-APOTEX-2016AP010599 | APOTEX | 75.00 | YR | M | Y | 73.10000 | KG | 20160825 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126842051 | 12684205 | 1 | PS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | 1000 MG, BID | 90499 | 1000 | MG | TABLET | BID | ||||||
| 126842051 | 12684205 | 2 | SS | NIVOLUMAB | NIVOLUMAB | 1 | Unknown | 1 MG/KG, UNK | 0 | 1 | MG/KG | ||||||||
| 126842051 | 12684205 | 3 | SS | IPILIMUMAB | IPILIMUMAB | 1 | Unknown | 3 MG/KG, UNK | 0 | 3 | MG/KG | ||||||||
| 126842051 | 12684205 | 4 | SS | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Intravenous (not otherwise specified) | 500 MG, UNK | 0 | 500 | MG | ||||||||
| 126842051 | 12684205 | 5 | SS | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Intravenous (not otherwise specified) | 140 MG, BID | 0 | 140 | MG | BID | |||||||
| 126842051 | 12684205 | 6 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 60 MG, DAILY | 0 | 60 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126842051 | 12684205 | 1 | Tubulointerstitial nephritis |
| 126842051 | 12684205 | 2 | Metastatic malignant melanoma |
| 126842051 | 12684205 | 3 | Metastatic malignant melanoma |
| 126842051 | 12684205 | 4 | Tubulointerstitial nephritis |
| 126842051 | 12684205 | 6 | Tubulointerstitial nephritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126842051 | 12684205 | OT |
| 126842051 | 12684205 | HO |
| 126842051 | 12684205 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126842051 | 12684205 | Enterocolitis haemorrhagic | |
| 126842051 | 12684205 | Pancytopenia | |
| 126842051 | 12684205 | Pseudomonas infection | |
| 126842051 | 12684205 | Septic shock |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |