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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122308618 | 12230861 | 8 | F | 201510 | 20160822 | 20160401 | 20160826 | EXP | US-UNITED THERAPEUTICS-UNT-2015-013450 | UNITED THERAPEUTICS | 54.99 | YR | F | Y | 50.98000 | KG | 20160826 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122308618 | 12230861 | 1 | PS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | 0.097 ?G/KG, CONTINUING | 2100578 | 21272 | .097 | UG/KG | INJECTION | ||||||
| 122308618 | 12230861 | 2 | SS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | 0.100 ?G/KG, CONTINUING | 2100703 | 21272 | .1 | UG/KG | INJECTION | ||||||
| 122308618 | 12230861 | 3 | SS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | 0.099 ?G/KG,CONTINUING | 926117 | 21272 | .099 | UG/KG | INJECTION | ||||||
| 122308618 | 12230861 | 4 | SS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | UNK | 926618 | 21272 | INJECTION | ||||||||
| 122308618 | 12230861 | 5 | SS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | 0.094 ?G/KG, CONTINUING | 21272 | .094 | UG/KG | INJECTION | |||||||
| 122308618 | 12230861 | 6 | SS | REVATIO | SILDENAFIL CITRATE | 1 | Oral | 80 MG, TID | 0 | 80 | MG | TID | |||||||
| 122308618 | 12230861 | 7 | SS | REVATIO | SILDENAFIL CITRATE | 1 | 0 | ||||||||||||
| 122308618 | 12230861 | 8 | SS | REVATIO | SILDENAFIL CITRATE | 1 | 0 | ||||||||||||
| 122308618 | 12230861 | 9 | SS | LETAIRIS | AMBRISENTAN | 1 | Oral | 10 MG, QD | SBFX | 0 | 10 | MG | TABLET | QD | |||||
| 122308618 | 12230861 | 10 | SS | LETAIRIS | AMBRISENTAN | 1 | Oral | UNK | 1500226A | 0 | TABLET | ||||||||
| 122308618 | 12230861 | 11 | SS | LETAIRIS | AMBRISENTAN | 1 | Oral | 20 MG, QD | SBFT | 0 | 20 | MG | TABLET | QD | |||||
| 122308618 | 12230861 | 12 | SS | LETAIRIS | AMBRISENTAN | 1 | Oral | 5 MG, QD | NZYD | 0 | 5 | MG | TABLET | QD | |||||
| 122308618 | 12230861 | 13 | SS | LETAIRIS | AMBRISENTAN | 1 | Oral | 5 MG, UNK | 0 | 5 | MG | TABLET | |||||||
| 122308618 | 12230861 | 14 | SS | ADCIRCA | TADALAFIL | 1 | Unknown | 40 MG, UNK | U | U | 0 | 40 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122308618 | 12230861 | 1 | Pulmonary hypertension |
| 122308618 | 12230861 | 2 | Pulmonary arterial hypertension |
| 122308618 | 12230861 | 6 | Osteopenia |
| 122308618 | 12230861 | 7 | Pulmonary arterial hypertension |
| 122308618 | 12230861 | 8 | Pulmonary hypertension |
| 122308618 | 12230861 | 9 | Pulmonary hypertension |
| 122308618 | 12230861 | 10 | Pulmonary arterial hypertension |
| 122308618 | 12230861 | 14 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122308618 | 12230861 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122308618 | 12230861 | Asthma | |
| 122308618 | 12230861 | Bacteraemia | |
| 122308618 | 12230861 | Blood immunoglobulin E increased | |
| 122308618 | 12230861 | Bronchopulmonary aspergillosis | |
| 122308618 | 12230861 | Chronic obstructive pulmonary disease | |
| 122308618 | 12230861 | Cough | |
| 122308618 | 12230861 | Device use error | |
| 122308618 | 12230861 | Dyspnoea | |
| 122308618 | 12230861 | Eye discharge | |
| 122308618 | 12230861 | Headache | |
| 122308618 | 12230861 | Malaise | |
| 122308618 | 12230861 | Muscle spasms | |
| 122308618 | 12230861 | Nasopharyngitis | |
| 122308618 | 12230861 | Nausea | |
| 122308618 | 12230861 | Ocular hyperaemia | |
| 122308618 | 12230861 | Osteoporosis | |
| 122308618 | 12230861 | Therapy cessation | |
| 122308618 | 12230861 | Upper respiratory tract infection | |
| 122308618 | 12230861 | Urinary tract infection | |
| 122308618 | 12230861 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 122308618 | 12230861 | 1 | 20150409 | 0 | ||
| 122308618 | 12230861 | 9 | 20150410 | 0 | ||
| 122308618 | 12230861 | 10 | 20150410 | 0 | ||
| 122308618 | 12230861 | 11 | 20151028 | 0 |