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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118246747 | 11824674 | 7 | F | 20151121 | 20160823 | 20151210 | 20160901 | EXP | US-ACTELION-A-NJ2015-128478 | ACTELION | 72.00 | YR | E | F | Y | 0.00000 | 20160901 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118246747 | 11824674 | 1 | PS | OPSUMIT | MACITENTAN | 1 | Oral | 10 MG, QD | Y | UM017N0301,UM017N0401 | 204410 | 10 | MG | TABLET | QD | ||||
| 118246747 | 11824674 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 12 NG/KG, PER MIN | U | V926, S706, V380 | 0 | /min | |||||||
| 118246747 | 11824674 | 3 | C | RIOCIGUAT | RIOCIGUAT | 1 | U | 0 | |||||||||||
| 118246747 | 11824674 | 4 | C | WARFARIN | WARFARIN | 1 | U | 0 | |||||||||||
| 118246747 | 11824674 | 5 | C | TYVASO | TREPROSTINIL | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118246747 | 11824674 | 1 | Pulmonary arterial hypertension |
| 118246747 | 11824674 | 2 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118246747 | 11824674 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118246747 | 11824674 | Acute respiratory failure | |
| 118246747 | 11824674 | Anaemia | |
| 118246747 | 11824674 | Cardiac failure congestive | |
| 118246747 | 11824674 | Chest pain | |
| 118246747 | 11824674 | Cough | |
| 118246747 | 11824674 | Dyspnoea | |
| 118246747 | 11824674 | Dyspnoea exertional | |
| 118246747 | 11824674 | Endotracheal intubation | |
| 118246747 | 11824674 | Haemoglobin decreased | |
| 118246747 | 11824674 | Headache | |
| 118246747 | 11824674 | Hypotension | |
| 118246747 | 11824674 | Hypoxia | |
| 118246747 | 11824674 | Influenza like illness | |
| 118246747 | 11824674 | International normalised ratio increased | |
| 118246747 | 11824674 | Occult blood | |
| 118246747 | 11824674 | Oxygen saturation decreased | |
| 118246747 | 11824674 | Packed red blood cell transfusion | |
| 118246747 | 11824674 | Pulmonary arterial pressure increased | |
| 118246747 | 11824674 | Red blood cell count decreased | |
| 118246747 | 11824674 | Respiratory disorder | |
| 118246747 | 11824674 | Retching | |
| 118246747 | 11824674 | Upper respiratory tract infection | |
| 118246747 | 11824674 | Urinary tract infection | |
| 118246747 | 11824674 | 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 |
|---|---|---|---|---|---|---|
| 118246747 | 11824674 | 1 | 20151104 | 20151202 | 0 | |
| 118246747 | 11824674 | 2 | 201510 | 0 |