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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124294863 | 12429486 | 3 | F | 20150403 | 20160721 | 20160602 | 20160802 | EXP | US-VALIDUS PHARMACEUTICALS LLC-US-2016VAL001710 | VALIDUS | 0.00 | Y | 0.00000 | 20160802 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124294863 | 12429486 | 1 | PS | LASIX | FUROSEMIDE | 1 | Oral | 40 MG, DAILY | U | 16273 | 40 | MG | |||||||
| 124294863 | 12429486 | 2 | SS | TYVASO | TREPROSTINIL | 1 | 216 ?G, INHALATIONAL;DAILY | 64368 | UG | U | 0 | 216 | UG | INHALATION GAS | |||||
| 124294863 | 12429486 | 3 | SS | TYVASO | TREPROSTINIL | 1 | Respiratory (inhalation) | 216 ?G, 4 TIMES A DAY | 64368 | UG | U | 0 | 216 | UG | INHALATION GAS | ||||
| 124294863 | 12429486 | 4 | SS | TYVASO | TREPROSTINIL | 1 | 54 ?G, INHALATIONAL;4 TIMES A DAY | 64368 | UG | U | 0 | 54 | UG | INHALATION GAS | |||||
| 124294863 | 12429486 | 5 | C | ALLOPURINOL. | ALLOPURINOL | 1 | Oral | 300 MG, DAILY | 0 | 300 | MG | ||||||||
| 124294863 | 12429486 | 6 | C | COUMADIN | WARFARIN SODIUM | 1 | Oral | 5 MG, DAILY | 0 | 5 | MG | ||||||||
| 124294863 | 12429486 | 7 | C | VICODIN ES | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | Oral | 1500 MG-15 MG, DAILY | 0 | ||||||||||
| 124294863 | 12429486 | 8 | C | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | Oral | 40 MG, DAILY | 0 | 40 | MG | ||||||||
| 124294863 | 12429486 | 9 | C | INDOMETHACIN /00003801/ | INDOMETHACIN | 1 | Oral | UNK, PRN | 0 | ||||||||||
| 124294863 | 12429486 | 10 | C | REVATIO | SILDENAFIL CITRATE | 1 | Oral | 2400 MG, UNK | 0 | 2400 | MG | ||||||||
| 124294863 | 12429486 | 11 | C | REVATIO | SILDENAFIL CITRATE | 1 | Oral | 80 MG, TID | 0 | 80 | MG | ||||||||
| 124294863 | 12429486 | 12 | C | BUMETANIDE. | BUMETANIDE | 1 | Oral | 1 MG, DAILY | 0 | 1 | MG | ||||||||
| 124294863 | 12429486 | 13 | C | BUMETANIDE. | BUMETANIDE | 1 | 0 | ||||||||||||
| 124294863 | 12429486 | 14 | C | LETAIRIS | AMBRISENTAN | 1 | Oral | 10 MG, TOTAL | 0 | 10 | MG | ||||||||
| 124294863 | 12429486 | 15 | C | LETAIRIS | AMBRISENTAN | 1 | 0 | ||||||||||||
| 124294863 | 12429486 | 16 | C | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Oral | 20 MG, DAILY | 0 | 20 | MG | ||||||||
| 124294863 | 12429486 | 17 | C | MELOXICAM. | MELOXICAM | 1 | Oral | 15 MG, DAILY | 0 | 15 | MG | ||||||||
| 124294863 | 12429486 | 18 | C | PAROXETINE. | PAROXETINE | 1 | Oral | 10 MG, DAILY | 0 | 10 | MG | ||||||||
| 124294863 | 12429486 | 19 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 80 MG, UNK | 0 | 80 | MG | ||||||||
| 124294863 | 12429486 | 20 | C | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | Oral | 2-4 MG, ONCE EVERY FOUR HOURS AS NEEDED | U | 0 | |||||||||
| 124294863 | 12429486 | 21 | C | DURAGESIC | FENTANYL | 1 | Transdermal | 33 ?G, DAILY | U | 0 | 33 | UG | |||||||
| 124294863 | 12429486 | 22 | C | DURAGESIC | FENTANYL | 1 | U | 0 | |||||||||||
| 124294863 | 12429486 | 23 | C | LORTAB | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | Oral | 7.5-325 MG Q4H | U | 0 | |||||||||
| 124294863 | 12429486 | 24 | C | ESTAZOLAM. | ESTAZOLAM | 1 | Oral | 2 MG, TID | U | 0 | 2 | MG | |||||||
| 124294863 | 12429486 | 25 | C | AMPHETAMIN SALTS | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | Oral | 30 MG, TID | U | 0 | 30 | MG | |||||||
| 124294863 | 12429486 | 26 | C | IRON | IRON | 1 | Oral | 325 MG, DAILY | U | 0 | 325 | MG | |||||||
| 124294863 | 12429486 | 27 | C | ITRACONAZOLE. | ITRACONAZOLE | 1 | Oral | 100 MG, BID | U | 0 | 100 | MG | |||||||
| 124294863 | 12429486 | 28 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | ||||||||||
| 124294863 | 12429486 | 29 | C | PROTONIX | PANTOPRAZOLE SODIUM | 1 | UNK | U | 0 | ||||||||||
| 124294863 | 12429486 | 30 | C | FENTANIL | FENTANYL | 1 | 30 ?G, UNK | U | 0 | 30 | UG | PATCH |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124294863 | 12429486 | 1 | Oedema |
| 124294863 | 12429486 | 2 | Pulmonary arterial hypertension |
| 124294863 | 12429486 | 5 | Gout |
| 124294863 | 12429486 | 6 | Pulmonary arterial hypertension |
| 124294863 | 12429486 | 7 | Osteoarthritis |
| 124294863 | 12429486 | 8 | Depression |
| 124294863 | 12429486 | 9 | Gout |
| 124294863 | 12429486 | 10 | Hypertension |
| 124294863 | 12429486 | 11 | Pulmonary hypertension |
| 124294863 | 12429486 | 12 | Hypertension |
| 124294863 | 12429486 | 13 | Pulmonary hypertension |
| 124294863 | 12429486 | 14 | Hypertension |
| 124294863 | 12429486 | 15 | Pulmonary arterial hypertension |
| 124294863 | 12429486 | 16 | Hypertension |
| 124294863 | 12429486 | 17 | Osteoarthritis |
| 124294863 | 12429486 | 18 | Obsessive-compulsive disorder |
| 124294863 | 12429486 | 19 | Pulmonary arterial hypertension |
| 124294863 | 12429486 | 20 | Product used for unknown indication |
| 124294863 | 12429486 | 21 | Osteoarthritis |
| 124294863 | 12429486 | 22 | Back pain |
| 124294863 | 12429486 | 23 | Pain |
| 124294863 | 12429486 | 24 | Depression |
| 124294863 | 12429486 | 25 | Product used for unknown indication |
| 124294863 | 12429486 | 26 | Supplementation therapy |
| 124294863 | 12429486 | 27 | Diuretic therapy |
| 124294863 | 12429486 | 28 | Product used for unknown indication |
| 124294863 | 12429486 | 29 | Prophylaxis |
| 124294863 | 12429486 | 30 | Osteoarthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124294863 | 12429486 | DS |
| 124294863 | 12429486 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124294863 | 12429486 | Deep vein thrombosis | |
| 124294863 | 12429486 | Hypokalaemia | |
| 124294863 | 12429486 | Hypomagnesaemia | |
| 124294863 | 12429486 | Oedema peripheral | |
| 124294863 | 12429486 | Sepsis |
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 |
|---|---|---|---|---|---|---|
| 124294863 | 12429486 | 1 | 20090106 | 0 | ||
| 124294863 | 12429486 | 2 | 20140610 | 20150509 | 0 | |
| 124294863 | 12429486 | 3 | 20141015 | 0 | ||
| 124294863 | 12429486 | 5 | 20131230 | 0 | ||
| 124294863 | 12429486 | 6 | 20131230 | 0 | ||
| 124294863 | 12429486 | 7 | 20090106 | 0 | ||
| 124294863 | 12429486 | 8 | 20131230 | 0 | ||
| 124294863 | 12429486 | 9 | 20131230 | 0 | ||
| 124294863 | 12429486 | 10 | 20090106 | 0 | ||
| 124294863 | 12429486 | 11 | 20150319 | 0 | ||
| 124294863 | 12429486 | 12 | 20131230 | 0 | ||
| 124294863 | 12429486 | 14 | 20090106 | 0 | ||
| 124294863 | 12429486 | 16 | 20131230 | 0 | ||
| 124294863 | 12429486 | 17 | 20131230 | 0 | ||
| 124294863 | 12429486 | 18 | 20131230 | 0 | ||
| 124294863 | 12429486 | 19 | 20131230 | 0 | ||
| 124294863 | 12429486 | 20 | 20150403 | 0 | ||
| 124294863 | 12429486 | 21 | 20150305 | 0 | ||
| 124294863 | 12429486 | 23 | 20150305 | 0 | ||
| 124294863 | 12429486 | 24 | 20150305 | 0 | ||
| 124294863 | 12429486 | 25 | 20150305 | 0 | ||
| 124294863 | 12429486 | 26 | 20150305 | 0 | ||
| 124294863 | 12429486 | 27 | 20150305 | 0 | ||
| 124294863 | 12429486 | 30 | 2013 | 0 |