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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125783731 | 12578373 | 1 | I | 20160707 | 20160721 | 20160721 | EXP | US-AUROBINDO-AUR-APL-2016-09446 | AUROBINDO | 65.00 | YR | M | Y | 0.00000 | 20160721 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125783731 | 12578373 | 1 | PS | Trimethoprim+Sulfamethoxazole | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Unknown | U | U | 90624 | |||||||||
| 125783731 | 12578373 | 2 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | TITRATED TO MAINTAIN 12-HOUR TACROLIMUS TROUGH LEVEL OF 8 NG/ML | U | U | 0 | ||||||||
| 125783731 | 12578373 | 3 | C | MYCOPHENOLIC ACID. | MYCOPHENOLIC ACID | 1 | Unknown | U | 0 | ||||||||||
| 125783731 | 12578373 | 4 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125783731 | 12578373 | 1 | Prophylaxis |
| 125783731 | 12578373 | 2 | Immunosuppressant drug therapy |
| 125783731 | 12578373 | 3 | Immunosuppressant drug therapy |
| 125783731 | 12578373 | 4 | Immunosuppressant drug therapy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125783731 | 12578373 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125783731 | 12578373 | Hyperkalaemia | |
| 125783731 | 12578373 | Hypertension | |
| 125783731 | 12578373 | Metabolic acidosis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |