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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125943611 | 12594361 | 1 | I | 201511 | 20151230 | 20160726 | 20160726 | EXP | US-UNITED THERAPEUTICS-UNT-2015-016627 | UNITED THERAPEUTICS | 70.68 | YR | F | Y | 88.89000 | KG | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125943611 | 12594361 | 1 | PS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 0.023 ?G/KG, CONTINUING | U | U | 926118 | 21272 | .023 | UG/KG | INJECTION | ||||
| 125943611 | 12594361 | 2 | SS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 0.023 ?G/KG, CONTINUING | U | U | 926118 | 21272 | .023 | UG/KG | INJECTION | ||||
| 125943611 | 12594361 | 3 | SS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 0.025 ?G/KG, CONTINUING | U | U | 2100666 | 21272 | .025 | UG/KG | INJECTION | ||||
| 125943611 | 12594361 | 4 | SS | ADCIRCA | TADALAFIL | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125943611 | 12594361 | 5 | SS | XARELTO | RIVAROXABAN | 1 | Unknown | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125943611 | 12594361 | 1 | Pulmonary hypertension |
| 125943611 | 12594361 | 4 | Product used for unknown indication |
| 125943611 | 12594361 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125943611 | 12594361 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125943611 | 12594361 | Abdominal discomfort | |
| 125943611 | 12594361 | Bleeding time prolonged | |
| 125943611 | 12594361 | Bruxism | |
| 125943611 | 12594361 | Dehydration | |
| 125943611 | 12594361 | Diarrhoea | |
| 125943611 | 12594361 | Dyspnoea | |
| 125943611 | 12594361 | Flushing | |
| 125943611 | 12594361 | Gastrooesophageal reflux disease | |
| 125943611 | 12594361 | Gingival bleeding | |
| 125943611 | 12594361 | Gingival disorder | |
| 125943611 | 12594361 | Gingival recession | |
| 125943611 | 12594361 | Haemorrhage | |
| 125943611 | 12594361 | Headache | |
| 125943611 | 12594361 | Hypoaesthesia oral | |
| 125943611 | 12594361 | Increased viscosity of upper respiratory secretion | |
| 125943611 | 12594361 | Influenza like illness | |
| 125943611 | 12594361 | Infusion site bruising | |
| 125943611 | 12594361 | Infusion site haemorrhage | |
| 125943611 | 12594361 | Infusion site infection | |
| 125943611 | 12594361 | Infusion site reaction | |
| 125943611 | 12594361 | Malaise | |
| 125943611 | 12594361 | Nasal dryness | |
| 125943611 | 12594361 | Nausea | |
| 125943611 | 12594361 | Ocular discomfort | |
| 125943611 | 12594361 | Pain | |
| 125943611 | 12594361 | Palpitations | |
| 125943611 | 12594361 | Salivary hypersecretion | |
| 125943611 | 12594361 | Therapy non-responder | |
| 125943611 | 12594361 | Tooth disorder | |
| 125943611 | 12594361 | Upper-airway cough syndrome | |
| 125943611 | 12594361 | 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 |
|---|---|---|---|---|---|---|
| 125943611 | 12594361 | 1 | 20150820 | 0 | ||
| 125943611 | 12594361 | 2 | 20150903 | 0 | ||
| 125943611 | 12594361 | 4 | 20151229 | 0 |