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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127400531 | 12740053 | 1 | I | 201204 | 20160902 | 20160913 | 20160913 | EXP | JP-GILEAD-2016-0232617 | GILEAD | 69.00 | YR | E | F | Y | 46.60000 | KG | 20160913 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127400531 | 12740053 | 1 | PS | AMBRISENTAN | AMBRISENTAN | 1 | Oral | 5 MG, QD | 22081 | 5 | MG | TABLET | QD | ||||||
| 127400531 | 12740053 | 2 | SS | AMBRISENTAN | AMBRISENTAN | 1 | Oral | 7.5 MG, QD | 22081 | 7.5 | MG | TABLET | QD | ||||||
| 127400531 | 12740053 | 3 | SS | AMBRISENTAN | AMBRISENTAN | 1 | Unknown | 10 MG, QD | 22081 | 10 | MG | TABLET | QD | ||||||
| 127400531 | 12740053 | 4 | SS | AMBRISENTAN | AMBRISENTAN | 1 | Unknown | 5 MG, BID | 22081 | 5 | MG | TABLET | BID | ||||||
| 127400531 | 12740053 | 5 | SS | ZYLORIC | ALLOPURINOL | 1 | Oral | UNK | Y | N | 0 | ||||||||
| 127400531 | 12740053 | 6 | SS | ZYLORIC | ALLOPURINOL | 1 | Oral | UNK | Y | N | 0 | ||||||||
| 127400531 | 12740053 | 7 | SS | TERIBONE | TERIPARATIDE ACETATE | 1 | Subcutaneous | Y | 0 | ||||||||||
| 127400531 | 12740053 | 8 | SS | ADCIRCA | TADALAFIL | 1 | Oral | UNK | U | 0 | |||||||||
| 127400531 | 12740053 | 9 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | U | 0 | ||||||||||
| 127400531 | 12740053 | 10 | C | REVATIO | SILDENAFIL CITRATE | 1 | Oral | UNK | 0 | ||||||||||
| 127400531 | 12740053 | 11 | C | BERASUS LA | 2 | Oral | UNK | 0 | |||||||||||
| 127400531 | 12740053 | 12 | C | CARELOAD | BERAPROST SODIUM | 1 | Oral | UNK | 0 | ||||||||||
| 127400531 | 12740053 | 13 | C | FOLIAMIN | FOLIC ACID | 1 | Oral | 0 | |||||||||||
| 127400531 | 12740053 | 14 | C | FERROMIA | FERROUS CITRATE | 1 | Oral | 0 | |||||||||||
| 127400531 | 12740053 | 15 | C | WARFARIN | WARFARIN | 1 | Oral | 0 | |||||||||||
| 127400531 | 12740053 | 16 | C | LASIX | FUROSEMIDE | 1 | Oral | 0 | |||||||||||
| 127400531 | 12740053 | 17 | C | ZETIA | EZETIMIBE | 1 | Oral | UNK | 0 | ||||||||||
| 127400531 | 12740053 | 18 | C | TAKEPRON | LANSOPRAZOLE | 1 | Oral | 0 | |||||||||||
| 127400531 | 12740053 | 19 | C | FORTEO | TERIPARATIDE | 1 | Subcutaneous | UNK | 0 | ||||||||||
| 127400531 | 12740053 | 20 | C | CELECOX | CELECOXIB | 1 | Oral | 0 | |||||||||||
| 127400531 | 12740053 | 21 | C | MUCOSTA | REBAMIPIDE | 1 | Oral | 0 | |||||||||||
| 127400531 | 12740053 | 22 | C | URSO | URSODIOL | 1 | Oral | 0 | |||||||||||
| 127400531 | 12740053 | 23 | C | ALDACTONE | SPIRONOLACTONE | 1 | Oral | UNK | 0 | ||||||||||
| 127400531 | 12740053 | 24 | C | PRALIA | DENOSUMAB | 1 | Subcutaneous | UNK | 0 | ||||||||||
| 127400531 | 12740053 | 25 | C | EDIROL | ELDECALCITOL | 1 | Oral | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127400531 | 12740053 | 1 | Pulmonary arterial hypertension |
| 127400531 | 12740053 | 5 | Product used for unknown indication |
| 127400531 | 12740053 | 7 | Product used for unknown indication |
| 127400531 | 12740053 | 8 | Pulmonary arterial hypertension |
| 127400531 | 12740053 | 9 | Product used for unknown indication |
| 127400531 | 12740053 | 10 | Pulmonary arterial hypertension |
| 127400531 | 12740053 | 11 | Pulmonary arterial hypertension |
| 127400531 | 12740053 | 12 | Pulmonary arterial hypertension |
| 127400531 | 12740053 | 15 | Thrombosis prophylaxis |
| 127400531 | 12740053 | 18 | Gastritis prophylaxis |
| 127400531 | 12740053 | 21 | Gastritis prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127400531 | 12740053 | HO |
| 127400531 | 12740053 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127400531 | 12740053 | Cardiac failure | |
| 127400531 | 12740053 | Diabetes mellitus | |
| 127400531 | 12740053 | Off label use | |
| 127400531 | 12740053 | Toxic skin eruption | |
| 127400531 | 12740053 | Ventricular extrasystoles |
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 |
|---|---|---|---|---|---|---|
| 127400531 | 12740053 | 1 | 201204 | 201204 | 0 | |
| 127400531 | 12740053 | 2 | 201204 | 201205 | 0 | |
| 127400531 | 12740053 | 3 | 201205 | 20120723 | 0 | |
| 127400531 | 12740053 | 4 | 20120724 | 0 | ||
| 127400531 | 12740053 | 5 | 20120905 | 0 | ||
| 127400531 | 12740053 | 6 | 20120924 | 0 | ||
| 127400531 | 12740053 | 8 | 20120821 | 20120905 | 0 | |
| 127400531 | 12740053 | 10 | 20120820 | 0 | ||
| 127400531 | 12740053 | 11 | 20120510 | 0 | ||
| 127400531 | 12740053 | 12 | 20120511 | 0 | ||
| 127400531 | 12740053 | 17 | 20130415 | 0 | ||
| 127400531 | 12740053 | 19 | 20141022 | 0 | ||
| 127400531 | 12740053 | 24 | 20141027 | 0 | ||
| 127400531 | 12740053 | 25 | 20140929 | 0 |