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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125944211 | 12594421 | 1 | I | 20160501 | 20160510 | 20160726 | 20160726 | PER | US-UNITED THERAPEUTICS-UNT-2016-007592 | UNITED THERAPEUTICS | 45.00 | YR | F | Y | 0.00000 | 20160726 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125944211 | 12594421 | 1 | PS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | UNK | Y | 21272 | INJECTION | ||||||||
| 125944211 | 12594421 | 2 | SS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | 0.040 ?G/KG, CONTINUING | Y | 21272 | .04 | UG/KG | INJECTION | ||||||
| 125944211 | 12594421 | 3 | SS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | 0.038 ?G/KG, CONTINUING | Y | 21272 | .038 | UG/KG | INJECTION | ||||||
| 125944211 | 12594421 | 4 | SS | REMODULIN | TREPROSTINIL | 1 | UNK | Y | 21272 | INJECTION | |||||||||
| 125944211 | 12594421 | 5 | SS | AMBRISENTAN | AMBRISENTAN | 1 | Unknown | 10 MG, QD | 0 | 10 | MG | TABLET | QD | ||||||
| 125944211 | 12594421 | 6 | SS | AMBRISENTAN | AMBRISENTAN | 1 | Unknown | 10 MG, QD | 1504767A | 0 | 10 | MG | TABLET | QD | |||||
| 125944211 | 12594421 | 7 | SS | ADCIRCA | TADALAFIL | 1 | Unknown | U | U | 0 | |||||||||
| 125944211 | 12594421 | 8 | C | COLCHICINE. | COLCHICINE | 1 | 0 | ||||||||||||
| 125944211 | 12594421 | 9 | C | TRAMADOL. | TRAMADOL | 1 | 0 | ||||||||||||
| 125944211 | 12594421 | 10 | C | PREDNISONE. | PREDNISONE | 1 | 0 | ||||||||||||
| 125944211 | 12594421 | 11 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | 0 | ||||||||||||
| 125944211 | 12594421 | 12 | C | ALLOPURINOL. | ALLOPURINOL | 1 | 0 | ||||||||||||
| 125944211 | 12594421 | 13 | C | LORTAB | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | 0 | ||||||||||||
| 125944211 | 12594421 | 14 | C | TIKOSYN | DOFETILIDE | 1 | 0 | ||||||||||||
| 125944211 | 12594421 | 15 | C | ASPIRIN /00002701/ | ASPIRIN | 1 | 0 | ||||||||||||
| 125944211 | 12594421 | 16 | C | ALBUTEROL /00139501/ | ALBUTEROL | 1 | 0 | ||||||||||||
| 125944211 | 12594421 | 17 | C | FLOVENT | FLUTICASONE PROPIONATE | 1 | 0 | ||||||||||||
| 125944211 | 12594421 | 18 | C | POTASSIUM | POTASSIUM | 1 | 0 | ||||||||||||
| 125944211 | 12594421 | 19 | C | LASIX | FUROSEMIDE | 1 | 0 | ||||||||||||
| 125944211 | 12594421 | 20 | C | CARDIZEM | DILTIAZEM HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 125944211 | 12594421 | 21 | C | IBUPROFEN. | IBUPROFEN | 1 | 0 | ||||||||||||
| 125944211 | 12594421 | 22 | C | IRON | IRON | 1 | 0 | ||||||||||||
| 125944211 | 12594421 | 23 | C | ERGOCALCIFEROL. | ERGOCALCIFEROL | 1 | 0 | ||||||||||||
| 125944211 | 12594421 | 24 | C | MAGNESIUM | MAGNESIUM | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125944211 | 12594421 | 1 | Pulmonary arterial hypertension |
| 125944211 | 12594421 | 5 | Pulmonary arterial hypertension |
| 125944211 | 12594421 | 6 | Pulmonary hypertension |
| 125944211 | 12594421 | 7 | Product used for unknown indication |
| 125944211 | 12594421 | 8 | Product used for unknown indication |
| 125944211 | 12594421 | 9 | Product used for unknown indication |
| 125944211 | 12594421 | 10 | Product used for unknown indication |
| 125944211 | 12594421 | 11 | Product used for unknown indication |
| 125944211 | 12594421 | 12 | Product used for unknown indication |
| 125944211 | 12594421 | 13 | Product used for unknown indication |
| 125944211 | 12594421 | 14 | Product used for unknown indication |
| 125944211 | 12594421 | 15 | Product used for unknown indication |
| 125944211 | 12594421 | 16 | Product used for unknown indication |
| 125944211 | 12594421 | 17 | Product used for unknown indication |
| 125944211 | 12594421 | 18 | Product used for unknown indication |
| 125944211 | 12594421 | 19 | Product used for unknown indication |
| 125944211 | 12594421 | 20 | Product used for unknown indication |
| 125944211 | 12594421 | 21 | Product used for unknown indication |
| 125944211 | 12594421 | 22 | Product used for unknown indication |
| 125944211 | 12594421 | 23 | Product used for unknown indication |
| 125944211 | 12594421 | 24 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125944211 | 12594421 | Diarrhoea | |
| 125944211 | 12594421 | Headache | |
| 125944211 | 12594421 | Insomnia | |
| 125944211 | 12594421 | Menstrual disorder | |
| 125944211 | 12594421 | Nausea | |
| 125944211 | 12594421 | Pain in extremity | |
| 125944211 | 12594421 | Pain in jaw | |
| 125944211 | 12594421 | Restlessness | |
| 125944211 | 12594421 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 125944211 | 12594421 | 1 | 20160501 | 0 | ||
| 125944211 | 12594421 | 2 | 20160510 | 20160526 | 0 | |
| 125944211 | 12594421 | 3 | 20160526 | 0 | ||
| 125944211 | 12594421 | 5 | 20120731 | 0 | ||
| 125944211 | 12594421 | 6 | 20120801 | 0 |