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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124676263 | 12467626 | 3 | F | 201606 | 20160729 | 20160615 | 20160808 | EXP | US-UNITED THERAPEUTICS-UNT-2016-009414 | UNITED THERAPEUTICS | 60.97 | YR | F | Y | 0.00000 | 20160808 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124676263 | 12467626 | 1 | PS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 0.051 ?G/KG, CONTINUING | Y | 21272 | .051 | UG/KG | INJECTION | ||||||
| 124676263 | 12467626 | 2 | SS | REMODULIN | TREPROSTINIL | 1 | UNK | Y | 21272 | INJECTION | |||||||||
| 124676263 | 12467626 | 3 | C | VERSED | MIDAZOLAM HYDROCHLORIDE | 1 | 2 MG | 0 | |||||||||||
| 124676263 | 12467626 | 4 | C | OPSUMIT | MACITENTAN | 1 | 10 MG, TOTAL DAILY DOSE | 0 | |||||||||||
| 124676263 | 12467626 | 5 | C | WARFARIN | WARFARIN | 1 | 5 MG, TOTAL DAILY DOSE | 0 | |||||||||||
| 124676263 | 12467626 | 6 | C | ALLOPURINOL. | ALLOPURINOL | 1 | 0 | ||||||||||||
| 124676263 | 12467626 | 7 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | 10 MG, TOTAL DAILY DOSE | 0 | |||||||||||
| 124676263 | 12467626 | 8 | C | CARVEDILOL. | CARVEDILOL | 1 | 3.125 MG, BID | 0 | 3.125 | MG | BID | ||||||||
| 124676263 | 12467626 | 9 | C | FERROUS SULFATE. | FERROUS SULFATE | 1 | Oral | 300 MG, Q8H | 0 | 300 | MG | TID | |||||||
| 124676263 | 12467626 | 10 | C | FOLIC ACID. | FOLIC ACID | 1 | Oral | 1 MG, QD | 0 | 1 | MG | QD | |||||||
| 124676263 | 12467626 | 11 | C | HYDRALAZINE | HYDRALAZINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 124676263 | 12467626 | 12 | C | ISOSORBIDE MONONITRATE. | ISOSORBIDE MONONITRATE | 1 | 0 | ||||||||||||
| 124676263 | 12467626 | 13 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | 25 MG, TOTAL DAILY DOSE | 0 | |||||||||||
| 124676263 | 12467626 | 14 | C | CHLORHEXIDINE GLUCONATE. | CHLORHEXIDINE GLUCONATE | 1 | Oral | 15 ML, BID | 0 | 15 | ML | BID | |||||||
| 124676263 | 12467626 | 15 | C | DIAZEPAM. | DIAZEPAM | 1 | Oral | 5 MG, Q12H | 0 | 5 | MG | BID | |||||||
| 124676263 | 12467626 | 16 | C | INSULIN LISPRO | INSULIN LISPRO | 1 | Subcutaneous | 1-6 UNITS, Q6H | 0 | ||||||||||
| 124676263 | 12467626 | 17 | C | METHADONE | METHADONE HYDROCHLORIDE | 1 | Oral | 20 MG, BID | 0 | 20 | MG | TABLET | BID | ||||||
| 124676263 | 12467626 | 18 | C | PANTOPRAZOLE | PANTOPRAZOLE SODIUM | 1 | Oral | 40 MG, TDD | 0 | ||||||||||
| 124676263 | 12467626 | 19 | C | POLYVINYL ALCOHOL | POLYVINYL ALCOHOL | 1 | Ophthalmic | 2 DROPS EACH EYE, Q4H | 0 | ||||||||||
| 124676263 | 12467626 | 20 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 20 MG, QD | 0 | 20 | MG | QD | |||||||
| 124676263 | 12467626 | 21 | C | QUETIAPINE. | QUETIAPINE | 1 | Oral | 25 MG, Q12H | 0 | 25 | MG | TABLET | BID | ||||||
| 124676263 | 12467626 | 22 | C | SENNA-S /00936101/ | 2 | 8.6 - 50 MG, 2 TABLETS | 0 | ||||||||||||
| 124676263 | 12467626 | 23 | C | DEXMEDETOMIDINE. | DEXMEDETOMIDINE | 1 | Intravenous drip | 0.4 ?G/KG/HOUR | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124676263 | 12467626 | 1 | Pulmonary arterial hypertension |
| 124676263 | 12467626 | 3 | Product used for unknown indication |
| 124676263 | 12467626 | 4 | Product used for unknown indication |
| 124676263 | 12467626 | 5 | Product used for unknown indication |
| 124676263 | 12467626 | 6 | Product used for unknown indication |
| 124676263 | 12467626 | 7 | Product used for unknown indication |
| 124676263 | 12467626 | 8 | Product used for unknown indication |
| 124676263 | 12467626 | 9 | Product used for unknown indication |
| 124676263 | 12467626 | 10 | Product used for unknown indication |
| 124676263 | 12467626 | 11 | Product used for unknown indication |
| 124676263 | 12467626 | 12 | Product used for unknown indication |
| 124676263 | 12467626 | 13 | Product used for unknown indication |
| 124676263 | 12467626 | 14 | Product used for unknown indication |
| 124676263 | 12467626 | 15 | Product used for unknown indication |
| 124676263 | 12467626 | 16 | Product used for unknown indication |
| 124676263 | 12467626 | 17 | Product used for unknown indication |
| 124676263 | 12467626 | 18 | Product used for unknown indication |
| 124676263 | 12467626 | 19 | Product used for unknown indication |
| 124676263 | 12467626 | 20 | Product used for unknown indication |
| 124676263 | 12467626 | 21 | Product used for unknown indication |
| 124676263 | 12467626 | 22 | Product used for unknown indication |
| 124676263 | 12467626 | 23 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124676263 | 12467626 | HO |
| 124676263 | 12467626 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124676263 | 12467626 | Acute kidney injury | |
| 124676263 | 12467626 | Atrial fibrillation | |
| 124676263 | 12467626 | Hypotension | |
| 124676263 | 12467626 | Liver function test increased | |
| 124676263 | 12467626 | Pneumonia | |
| 124676263 | 12467626 | Respiratory failure |
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 |
|---|---|---|---|---|---|---|
| 124676263 | 12467626 | 1 | 20100111 | 0 | ||
| 124676263 | 12467626 | 2 | 20120713 | 0 |