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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 94605822 | 9460582 | 2 | F | 20121026 | 20160907 | 20130815 | 20160919 | EXP | JP-GILEAD-2013-0081438 | GILEAD | 18.00 | YR | A | M | Y | 40.00000 | KG | 20160919 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 94605822 | 9460582 | 1 | PS | AMBRISENTAN | AMBRISENTAN | 1 | Oral | 2.5 MG, QD | 2952 | MG | Y | 22081 | 2.5 | MG | TABLET | QD | |||
| 94605822 | 9460582 | 2 | SS | AMBRISENTAN | AMBRISENTAN | 1 | Oral | 5 MG, QD | 2952 | MG | Y | 22081 | 5 | MG | TABLET | QD | |||
| 94605822 | 9460582 | 3 | SS | AMBRISENTAN | AMBRISENTAN | 1 | Oral | 5 MG, BID | 2952 | MG | Y | 22081 | 5 | MG | TABLET | BID | |||
| 94605822 | 9460582 | 4 | SS | AMBRISENTAN | AMBRISENTAN | 1 | Oral | 10 MG, QD | 2952 | MG | Y | 22081 | 10 | MG | TABLET | QD | |||
| 94605822 | 9460582 | 5 | SS | AMBRISENTAN | AMBRISENTAN | 1 | Oral | 7.5 MG, QD | 2952 | MG | Y | 22081 | 7.5 | MG | TABLET | QD | |||
| 94605822 | 9460582 | 6 | SS | AMBRISENTAN | AMBRISENTAN | 1 | Oral | 5 MG, QD | 2952 | MG | Y | 22081 | 5 | MG | TABLET | QD | |||
| 94605822 | 9460582 | 7 | SS | AMBRISENTAN | AMBRISENTAN | 1 | Oral | 2.5 MG, QD | 2952 | MG | Y | 22081 | 2.5 | MG | TABLET | QD | |||
| 94605822 | 9460582 | 8 | SS | REVATIO | SILDENAFIL CITRATE | 1 | Oral | UNK | Y | 0 | |||||||||
| 94605822 | 9460582 | 9 | SS | REVATIO | SILDENAFIL CITRATE | 1 | Oral | UNK | Y | 0 | |||||||||
| 94605822 | 9460582 | 10 | SS | ADCIRCA | TADALAFIL | 1 | Oral | UNK | D | 0 | TABLET | ||||||||
| 94605822 | 9460582 | 11 | SS | ADCIRCA | TADALAFIL | 1 | Unknown | UNK | D | 0 | TABLET | ||||||||
| 94605822 | 9460582 | 12 | SS | EPOPROSTENOL. | EPOPROSTENOL | 1 | Intravenous (not otherwise specified) | 28NG/KG MIN | Y | 0 | |||||||||
| 94605822 | 9460582 | 13 | SS | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | Oral | UNK | Y | 0 | |||||||||
| 94605822 | 9460582 | 14 | C | BARACLUDE | ENTECAVIR | 1 | UNK | 0 | |||||||||||
| 94605822 | 9460582 | 15 | C | HALFDIGOXIN | DIGOXIN | 1 | Oral | UNK | U | 0 | TABLET | ||||||||
| 94605822 | 9460582 | 16 | C | PROCYLIN | BERAPROST SODIUM | 1 | Oral | UNK | U | 0 | TABLET | ||||||||
| 94605822 | 9460582 | 17 | C | CARELOAD | BERAPROST SODIUM | 1 | Oral | UNK | 0 | ||||||||||
| 94605822 | 9460582 | 18 | C | DIGOSIN | DIGOXIN | 1 | Oral | UNK | U | 0 | ORAL DRUG UNSPECIFIED FORM | ||||||||
| 94605822 | 9460582 | 19 | C | FLUTIDE | FLUTICASONE PROPIONATE | 1 | Respiratory (inhalation) | UNK | 0 | ||||||||||
| 94605822 | 9460582 | 20 | C | K-SUPPLY | POTASSIUM CHLORIDE | 1 | UNK | 0 | |||||||||||
| 94605822 | 9460582 | 21 | C | TAKEPRON | LANSOPRAZOLE | 1 | UNK | 0 | |||||||||||
| 94605822 | 9460582 | 22 | C | TREPROST | 2 | 40NG/KG/MIN | 0 | ||||||||||||
| 94605822 | 9460582 | 23 | C | FERROSTEC | SODIUM FERROUS CITRATE | 1 | UNK | 0 | |||||||||||
| 94605822 | 9460582 | 24 | C | FERROUS SODIUM CITRATE | SODIUM FERROUS CITRATE | 1 | UNK | 0 | |||||||||||
| 94605822 | 9460582 | 25 | C | FERROUS SULFATE. | FERROUS SULFATE | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 94605822 | 9460582 | 1 | Pulmonary arterial hypertension |
| 94605822 | 9460582 | 8 | Pulmonary arterial hypertension |
| 94605822 | 9460582 | 10 | Pulmonary arterial hypertension |
| 94605822 | 9460582 | 12 | Pulmonary arterial hypertension |
| 94605822 | 9460582 | 13 | Product used for unknown indication |
| 94605822 | 9460582 | 14 | Hepatitis B |
| 94605822 | 9460582 | 15 | Cardiac failure |
| 94605822 | 9460582 | 16 | Pulmonary arterial hypertension |
| 94605822 | 9460582 | 17 | Pulmonary arterial hypertension |
| 94605822 | 9460582 | 18 | Cardiac failure |
| 94605822 | 9460582 | 19 | Asthma |
| 94605822 | 9460582 | 20 | Prophylaxis |
| 94605822 | 9460582 | 21 | Gastritis prophylaxis |
| 94605822 | 9460582 | 22 | Pulmonary arterial hypertension |
| 94605822 | 9460582 | 23 | Prophylaxis |
| 94605822 | 9460582 | 24 | Prophylaxis |
| 94605822 | 9460582 | 25 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 94605822 | 9460582 | OT |
| 94605822 | 9460582 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 94605822 | 9460582 | Breast pain | |
| 94605822 | 9460582 | Constipation | |
| 94605822 | 9460582 | Device related infection | |
| 94605822 | 9460582 | Fluid retention | |
| 94605822 | 9460582 | Gastritis | |
| 94605822 | 9460582 | Headache | |
| 94605822 | 9460582 | Hot flush | |
| 94605822 | 9460582 | Hypokalaemia | |
| 94605822 | 9460582 | Lymphadenitis | |
| 94605822 | 9460582 | Nasal congestion | |
| 94605822 | 9460582 | Off label use | |
| 94605822 | 9460582 | Pericardial effusion | |
| 94605822 | 9460582 | Pneumonia | |
| 94605822 | 9460582 | Pulmonary haemorrhage | |
| 94605822 | 9460582 | Rhinitis allergic |
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 |
|---|---|---|---|---|---|---|
| 94605822 | 9460582 | 1 | 20150629 | 2015 | 0 | |
| 94605822 | 9460582 | 2 | 20141022 | 20150628 | 0 | |
| 94605822 | 9460582 | 3 | 20131105 | 20141021 | 0 | |
| 94605822 | 9460582 | 4 | 20110726 | 0 | ||
| 94605822 | 9460582 | 5 | 20110615 | 20110725 | 0 | |
| 94605822 | 9460582 | 6 | 20110509 | 20110614 | 0 | |
| 94605822 | 9460582 | 7 | 20110425 | 20110508 | 0 | |
| 94605822 | 9460582 | 8 | 20140921 | 0 | ||
| 94605822 | 9460582 | 9 | 20141022 | 20150303 | 0 | |
| 94605822 | 9460582 | 10 | 20140922 | 20141021 | 0 | |
| 94605822 | 9460582 | 11 | 20150304 | 0 | ||
| 94605822 | 9460582 | 12 | 20141022 | 2015 | 0 | |
| 94605822 | 9460582 | 13 | 20150517 | 0 | ||
| 94605822 | 9460582 | 14 | 20131115 | 0 | ||
| 94605822 | 9460582 | 15 | 20131002 | 0 | ||
| 94605822 | 9460582 | 16 | 20131002 | 0 | ||
| 94605822 | 9460582 | 17 | 20131113 | 20141022 | 0 | |
| 94605822 | 9460582 | 18 | 20131113 | 0 | ||
| 94605822 | 9460582 | 19 | 20140917 | 0 | ||
| 94605822 | 9460582 | 22 | 2015 | 0 | ||
| 94605822 | 9460582 | 23 | 20150518 | 20150730 | 0 | |
| 94605822 | 9460582 | 24 | 20150731 | 20150810 | 0 | |
| 94605822 | 9460582 | 25 | 20150811 | 0 |