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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 90712979 | 9071297 | 9 | F | 20110928 | 20160628 | 20130129 | 20160708 | EXP | JP-GILEAD-2013-0068653 | GILEAD | 55.00 | YR | A | M | Y | 0.00000 | 20160708 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 90712979 | 9071297 | 1 | PS | AMBRISENTAN | AMBRISENTAN | 1 | Oral | 5 MG, QD | 8382.5 | MG | Y | 22081 | 5 | MG | TABLET | QD | |||
| 90712979 | 9071297 | 2 | SS | AMBRISENTAN | AMBRISENTAN | 1 | Oral | 7.5 MG, QD | 8382.5 | MG | Y | 22081 | 7.5 | MG | TABLET | QD | |||
| 90712979 | 9071297 | 3 | SS | ADCIRCA | TADALAFIL | 1 | Oral | UNK | Y | 0 | TABLET | ||||||||
| 90712979 | 9071297 | 4 | SS | BERASUS | BERAPROST SODIUM | 1 | Oral | UNK | Y | 0 | |||||||||
| 90712979 | 9071297 | 5 | SS | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Oral | UNK | Y | 0 | |||||||||
| 90712979 | 9071297 | 6 | SS | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Oral | UNK | Y | 0 | |||||||||
| 90712979 | 9071297 | 7 | C | TOYOFAROL | ALFACALCIDOL | 1 | Oral | UNK | U | 0 | CAPSULE | ||||||||
| 90712979 | 9071297 | 8 | C | TOYOFAROL | ALFACALCIDOL | 1 | Oral | UNK | U | 0 | CAPSULE | ||||||||
| 90712979 | 9071297 | 9 | C | TAKEPRON | LANSOPRAZOLE | 1 | Oral | UNK | U | 0 | TABLET | ||||||||
| 90712979 | 9071297 | 10 | C | TAKEPRON | LANSOPRAZOLE | 1 | Oral | UNK | U | 0 | TABLET | ||||||||
| 90712979 | 9071297 | 11 | C | HYPEN /00613801/ | ETODOLAC | 1 | Oral | UNK | 0 | ||||||||||
| 90712979 | 9071297 | 12 | C | GRIMAC | 2 | Oral | UNK | U | 0 | GRANULES | |||||||||
| 90712979 | 9071297 | 13 | C | GRIMAC | 2 | Oral | UNK | U | 0 | GRANULES | |||||||||
| 90712979 | 9071297 | 14 | C | MUCODYNE | CARBOCYSTEINE | 1 | Oral | U | 0 | ||||||||||
| 90712979 | 9071297 | 15 | C | MUCODYNE | CARBOCYSTEINE | 1 | Oral | UNK | U | 0 | |||||||||
| 90712979 | 9071297 | 16 | C | BACTRAMIN | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | UNK | U | 0 | ORAL DRUG UNSPECIFIED FORM | ||||||||
| 90712979 | 9071297 | 17 | C | BACTRAMIN | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | UNK | U | 0 | ORAL DRUG UNSPECIFIED FORM | ||||||||
| 90712979 | 9071297 | 18 | C | CATLEP | INDOMETHACIN | 1 | Transdermal | UNK | U | 0 | |||||||||
| 90712979 | 9071297 | 19 | C | CATLEP | INDOMETHACIN | 1 | Transdermal | UNK | U | 0 | |||||||||
| 90712979 | 9071297 | 20 | C | CATLEP | INDOMETHACIN | 1 | Transdermal | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 90712979 | 9071297 | 1 | Pulmonary arterial hypertension |
| 90712979 | 9071297 | 3 | Pulmonary arterial hypertension |
| 90712979 | 9071297 | 4 | Pulmonary arterial hypertension |
| 90712979 | 9071297 | 5 | Product used for unknown indication |
| 90712979 | 9071297 | 6 | Product used for unknown indication |
| 90712979 | 9071297 | 7 | Prophylaxis |
| 90712979 | 9071297 | 9 | Prophylaxis |
| 90712979 | 9071297 | 12 | Prophylaxis against gastrointestinal ulcer |
| 90712979 | 9071297 | 13 | Prophylaxis against gastrointestinal ulcer |
| 90712979 | 9071297 | 16 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 90712979 | 9071297 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 90712979 | 9071297 | Epistaxis | |
| 90712979 | 9071297 | Flushing | |
| 90712979 | 9071297 | Haematochezia | |
| 90712979 | 9071297 | Off label use | |
| 90712979 | 9071297 | Platelet count decreased | |
| 90712979 | 9071297 | Pruritus | |
| 90712979 | 9071297 | Renal impairment | |
| 90712979 | 9071297 | Scleroderma renal crisis | |
| 90712979 | 9071297 | White blood cell count increased |
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 |
|---|---|---|---|---|---|---|
| 90712979 | 9071297 | 1 | 20110928 | 20130109 | 0 | |
| 90712979 | 9071297 | 2 | 20130110 | 20150327 | 0 | |
| 90712979 | 9071297 | 3 | 20150327 | 0 | ||
| 90712979 | 9071297 | 4 | 20150327 | 0 | ||
| 90712979 | 9071297 | 5 | 20150327 | 0 | ||
| 90712979 | 9071297 | 6 | 20150327 | 0 | ||
| 90712979 | 9071297 | 8 | 20150327 | 0 | ||
| 90712979 | 9071297 | 10 | 20150327 | 0 | ||
| 90712979 | 9071297 | 13 | 20150327 | 0 | ||
| 90712979 | 9071297 | 15 | 20150327 | 0 | ||
| 90712979 | 9071297 | 17 | 20150327 | 0 | ||
| 90712979 | 9071297 | 18 | 20130213 | 0 | ||
| 90712979 | 9071297 | 19 | 20140401 | 0 | ||
| 90712979 | 9071297 | 20 | 20140401 | 20150327 | 0 |