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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119442563 | 11944256 | 3 | F | 201510 | 20160609 | 20160125 | 20160726 | EXP | US-UNITED THERAPEUTICS-UNT-2015-013561 | UNITED THERAPEUTICS | 70.23 | YR | M | Y | 68.27000 | KG | 20160726 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119442563 | 11944256 | 1 | PS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | 0.040 ?G/KG, CONTINUING | 2100703 | 21272 | .04 | UG/KG | INJECTION | ||||||
| 119442563 | 11944256 | 2 | SS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | 0.022 ?G/KG, CONTINUING | 926117 | 21272 | .022 | UG/KG | INJECTION | ||||||
| 119442563 | 11944256 | 3 | SS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | 0.043 ?G/KG, 24 HOURS | 21272 | .043 | UG/KG | INJECTION | |||||||
| 119442563 | 11944256 | 4 | SS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | 0.043 ?G/KG, CONTINUING | 2100909 | 21272 | .043 | UG/KG | INJECTION | ||||||
| 119442563 | 11944256 | 5 | SS | OPSUMIT | MACITENTAN | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 119442563 | 11944256 | 6 | C | OXYGEN. | OXYGEN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119442563 | 11944256 | 1 | Pulmonary arterial hypertension |
| 119442563 | 11944256 | 5 | Product used for unknown indication |
| 119442563 | 11944256 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 119442563 | 11944256 | HO |
| 119442563 | 11944256 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119442563 | 11944256 | Anaemia | |
| 119442563 | 11944256 | Chest discomfort | |
| 119442563 | 11944256 | Chills | |
| 119442563 | 11944256 | Cough | |
| 119442563 | 11944256 | Device issue | |
| 119442563 | 11944256 | Diarrhoea | |
| 119442563 | 11944256 | Dyspnoea | |
| 119442563 | 11944256 | Epistaxis | |
| 119442563 | 11944256 | Exercise tolerance decreased | |
| 119442563 | 11944256 | Haemorrhage | |
| 119442563 | 11944256 | Headache | |
| 119442563 | 11944256 | Hypopnoea | |
| 119442563 | 11944256 | Nasal dryness | |
| 119442563 | 11944256 | Overgrowth fungal | |
| 119442563 | 11944256 | Pain in extremity | |
| 119442563 | 11944256 | Pain in jaw | |
| 119442563 | 11944256 | Palmar erythema | |
| 119442563 | 11944256 | Pulmonary arterial hypertension | |
| 119442563 | 11944256 | Walking distance test abnormal |
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 |
|---|---|---|---|---|---|---|
| 119442563 | 11944256 | 1 | 20140212 | 0 | ||
| 119442563 | 11944256 | 2 | 20140220 | 0 | ||
| 119442563 | 11944256 | 5 | 20160127 | 0 |