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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127086711 | 12708671 | 1 | I | 20151001 | 20160809 | 20160901 | 20160901 | EXP | US-VALIDUS PHARMACEUTICALS LLC-US-2016VAL002489 | VALIDUS | 0.00 | Y | 0.00000 | 20160901 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127086711 | 12708671 | 1 | PS | FUROSEMIDE. | FUROSEMIDE | 1 | Oral | 20 MG, TOTAL DAILY DOSE | 880 | MG | Y | 16273 | 20 | MG | |||||
| 127086711 | 12708671 | 2 | SS | TREPROSTINIL | TREPROSTINIL | 1 | Oral | 2.75 MG, TID | 0 | 2.75 | MG | TABLET | |||||||
| 127086711 | 12708671 | 3 | SS | TREPROSTINIL | TREPROSTINIL | 1 | Oral | UNK | 0 | TABLET | |||||||||
| 127086711 | 12708671 | 4 | C | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | 4 MG, QD | Y | 0 | 4 | MG | ||||||||
| 127086711 | 12708671 | 5 | C | MYFORTIC | MYCOPHENOLATE SODIUM | 1 | Oral | 1440 MG, QD | U | 0 | 1440 | MG | |||||||
| 127086711 | 12708671 | 6 | C | VALCYTE | VALGANCICLOVIR HYDROCHLORIDE | 1 | Oral | 225 MG, QD | U | 0 | 225 | MG | |||||||
| 127086711 | 12708671 | 7 | C | BACTRIM DS | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 800-160 MG TOTAL DAILY DOSE | U | 0 | |||||||||
| 127086711 | 12708671 | 8 | C | PROTONIX | PANTOPRAZOLE SODIUM | 1 | Oral | 40 MG, QD | U | 0 | 40 | MG | |||||||
| 127086711 | 12708671 | 9 | C | MIDODRINE | MIDODRINE | 1 | Oral | 20 MG, QD | U | 0 | 20 | MG | |||||||
| 127086711 | 12708671 | 10 | C | FLOMAX | TAMSULOSIN HYDROCHLORIDE | 1 | 0.4 MG, QD | U | 0 | .4 | MG | ||||||||
| 127086711 | 12708671 | 11 | C | SIMVASTATIN. | SIMVASTATIN | 1 | Oral | 20 MG, QD | U | 0 | 20 | MG | |||||||
| 127086711 | 12708671 | 12 | C | DIGOXIN. | DIGOXIN | 1 | Oral | 0.125 MG, QD | U | 0 | .125 | MG | |||||||
| 127086711 | 12708671 | 13 | C | BOSENTAN. | BOSENTAN | 1 | 250 MG, QD | U | 0 | 250 | MG | ||||||||
| 127086711 | 12708671 | 14 | C | ALLOPURINOL. | ALLOPURINOL | 1 | Oral | 100 MG, QD | U | 0 | 100 | MG | |||||||
| 127086711 | 12708671 | 15 | C | WARFARIN | WARFARIN | 1 | Oral | 5 MG, QD | U | 0 | 5 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127086711 | 12708671 | 1 | Pulmonary arterial hypertension |
| 127086711 | 12708671 | 2 | Pulmonary arterial hypertension |
| 127086711 | 12708671 | 4 | Renal transplant |
| 127086711 | 12708671 | 5 | Renal transplant |
| 127086711 | 12708671 | 6 | Renal transplant |
| 127086711 | 12708671 | 7 | Renal transplant |
| 127086711 | 12708671 | 8 | Gastrooesophageal reflux disease |
| 127086711 | 12708671 | 9 | Renal transplant |
| 127086711 | 12708671 | 10 | Benign prostatic hyperplasia |
| 127086711 | 12708671 | 11 | Nephropathy |
| 127086711 | 12708671 | 12 | Nephropathy |
| 127086711 | 12708671 | 13 | Pulmonary arterial hypertension |
| 127086711 | 12708671 | 14 | Nephropathy |
| 127086711 | 12708671 | 15 | Atrial fibrillation |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127086711 | 12708671 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127086711 | 12708671 | Blood creatinine increased | |
| 127086711 | 12708671 | Diarrhoea |
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 |
|---|---|---|---|---|---|---|
| 127086711 | 12708671 | 1 | 20150819 | 20151104 | 0 | |
| 127086711 | 12708671 | 2 | 20151103 | 0 | ||
| 127086711 | 12708671 | 3 | 20150914 | 0 | ||
| 127086711 | 12708671 | 4 | 20150620 | 0 | ||
| 127086711 | 12708671 | 5 | 20150620 | 0 | ||
| 127086711 | 12708671 | 6 | 20150620 | 0 | ||
| 127086711 | 12708671 | 7 | 20150620 | 0 | ||
| 127086711 | 12708671 | 8 | 20150620 | 0 | ||
| 127086711 | 12708671 | 9 | 20150620 | 0 | ||
| 127086711 | 12708671 | 10 | 20150620 | 0 | ||
| 127086711 | 12708671 | 11 | 20130715 | 0 | ||
| 127086711 | 12708671 | 12 | 20121030 | 0 | ||
| 127086711 | 12708671 | 13 | 20120726 | 0 |