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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125098112 | 12509811 | 2 | F | 20150630 | 20160706 | 20160629 | 20160715 | EXP | JP-GILEAD-2016-0220878 | GILEAD | 44.00 | YR | A | F | Y | 45.00000 | KG | 20160715 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125098112 | 12509811 | 1 | PS | AMBRISENTAN | AMBRISENTAN | 1 | Oral | 10 MG, QD | 270 | MG | Y | 22081 | 10 | MG | TABLET | QD | |||
| 125098112 | 12509811 | 2 | SS | AMBRISENTAN | AMBRISENTAN | 1 | Oral | 5 MG, QD | 270 | MG | Y | 22081 | 5 | MG | TABLET | QD | |||
| 125098112 | 12509811 | 3 | SS | ADCIRCA | TADALAFIL | 1 | Oral | UNK | Y | 0 | |||||||||
| 125098112 | 12509811 | 4 | SS | REVATIO | SILDENAFIL CITRATE | 1 | Oral | UNK | Y | 0 | |||||||||
| 125098112 | 12509811 | 5 | SS | ADEMPAS | RIOCIGUAT | 1 | Oral | UNK | Y | 0 | |||||||||
| 125098112 | 12509811 | 6 | C | FUROSEMIDE. | FUROSEMIDE | 1 | UNK | 0 | |||||||||||
| 125098112 | 12509811 | 7 | C | FUROSEMIDE. | FUROSEMIDE | 1 | UNK | 0 | |||||||||||
| 125098112 | 12509811 | 8 | C | BERASUS LA | 2 | UNK | 0 | ||||||||||||
| 125098112 | 12509811 | 9 | C | MIYA-BM | CLOSTRIDIUM BUTYRICUM SPORES STRAIN M-55 | 1 | UNK | 0 | |||||||||||
| 125098112 | 12509811 | 10 | C | OPSUMIT | MACITENTAN | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125098112 | 12509811 | 1 | Pulmonary arterial hypertension |
| 125098112 | 12509811 | 3 | Pulmonary arterial hypertension |
| 125098112 | 12509811 | 4 | Pulmonary arterial hypertension |
| 125098112 | 12509811 | 5 | Pulmonary arterial hypertension |
| 125098112 | 12509811 | 8 | Pulmonary arterial hypertension |
| 125098112 | 12509811 | 9 | Prophylaxis against diarrhoea |
| 125098112 | 12509811 | 10 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125098112 | 12509811 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125098112 | 12509811 | Hepatic function abnormal | |
| 125098112 | 12509811 | Nausea |
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 |
|---|---|---|---|---|---|---|
| 125098112 | 12509811 | 1 | 20150610 | 20151215 | 0 | |
| 125098112 | 12509811 | 2 | 20150526 | 20150609 | 0 | |
| 125098112 | 12509811 | 3 | 20150516 | 20151103 | 0 | |
| 125098112 | 12509811 | 4 | 20150616 | 20151103 | 0 | |
| 125098112 | 12509811 | 5 | 20151104 | 0 | ||
| 125098112 | 12509811 | 6 | 20150514 | 0 | ||
| 125098112 | 12509811 | 7 | 20150514 | 0 | ||
| 125098112 | 12509811 | 8 | 20150616 | 0 | ||
| 125098112 | 12509811 | 9 | 20151027 | 0 | ||
| 125098112 | 12509811 | 10 | 20151215 | 0 |