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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126068821 | 12606882 | 1 | I | 20160721 | 20160729 | 20160729 | EXP | PHHY2016US103001 | SANDOZ | 61.00 | YR | F | Y | 0.00000 | 20160729 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126068821 | 12606882 | 1 | PS | PREDNISONE. | PREDNISONE | 1 | Unknown | 60 MG, QD | 80336 | 60 | MG | QD | |||||||
| 126068821 | 12606882 | 2 | SS | PREDNISONE. | PREDNISONE | 1 | 5 MG, QD | 80336 | 5 | MG | QD | ||||||||
| 126068821 | 12606882 | 3 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 2.5 MG, QD | 80336 | 2.5 | MG | QD | |||||||
| 126068821 | 12606882 | 4 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 20 MG, QD | 80336 | 20 | MG | QD | |||||||
| 126068821 | 12606882 | 5 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 10 MG, QD | 80336 | 10 | MG | QD | |||||||
| 126068821 | 12606882 | 6 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 15 MG, QD | 80336 | 15 | MG | QD | |||||||
| 126068821 | 12606882 | 7 | SS | PREDNISONE. | PREDNISONE | 1 | 60 MG, QD | 80336 | 60 | MG | QD | ||||||||
| 126068821 | 12606882 | 8 | SS | AZATHIOPRINE. | AZATHIOPRINE | 1 | Unknown | 50 MG, QD | N | 0 | 50 | MG | QD | ||||||
| 126068821 | 12606882 | 9 | SS | AZATHIOPRINE. | AZATHIOPRINE | 1 | Unknown | 100 MG, QD | N | 0 | 100 | MG | QD | ||||||
| 126068821 | 12606882 | 10 | SS | AZATHIOPRINE. | AZATHIOPRINE | 1 | Unknown | 150 MG, QD | N | 0 | 150 | MG | QD | ||||||
| 126068821 | 12606882 | 11 | SS | AZATHIOPRINE. | AZATHIOPRINE | 1 | Unknown | 200 MG, QD | N | 0 | 200 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126068821 | 12606882 | 1 | Autoimmune hepatitis |
| 126068821 | 12606882 | 8 | Autoimmune hepatitis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126068821 | 12606882 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126068821 | 12606882 | Alanine aminotransferase increased | |
| 126068821 | 12606882 | Drug ineffective | |
| 126068821 | 12606882 | Drug resistance | |
| 126068821 | 12606882 | Fibrosis | |
| 126068821 | 12606882 | Inflammation |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |