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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127161071 | 12716107 | 1 | I | 20160504 | 20160715 | 20160906 | 20160906 | EXP | US-ACTELION-A-CH2016-139514 | ACTELION | 25.00 | YR | A | F | Y | 59.20000 | KG | 20160906 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127161071 | 12716107 | 1 | PS | SELEXIPAG | SELEXIPAG | 1 | Oral | 1400 ?G, BID | 111600 | UG | Y | 15AIMPO33 | 104504 | 1400 | UG | TABLET | BID | ||
| 127161071 | 12716107 | 2 | SS | SELEXIPAG | SELEXIPAG | 1 | Oral | 1400 ?G, BID | 111600 | UG | Y | 15AIMPO33 | 207947 | 1400 | UG | TABLET | BID | ||
| 127161071 | 12716107 | 3 | SS | SELEXIPAG | SELEXIPAG | 1 | Oral | 200 ?G, BID | 111600 | UG | Y | 15AIMP033 | 104504 | 200 | UG | TABLET | BID | ||
| 127161071 | 12716107 | 4 | SS | SELEXIPAG | SELEXIPAG | 1 | Oral | 200 ?G, BID | 111600 | UG | Y | 15AIMP033 | 207947 | 200 | UG | TABLET | BID | ||
| 127161071 | 12716107 | 5 | SS | SELEXIPAG | SELEXIPAG | 1 | Oral | 400 ?G, BID | 111600 | UG | Y | 15AIMP033 | 104504 | 400 | UG | TABLET | BID | ||
| 127161071 | 12716107 | 6 | SS | SELEXIPAG | SELEXIPAG | 1 | Oral | 400 ?G, BID | 111600 | UG | Y | 15AIMP033 | 207947 | 400 | UG | TABLET | BID | ||
| 127161071 | 12716107 | 7 | SS | SELEXIPAG | SELEXIPAG | 1 | Oral | 600 ?G, BID | 111600 | UG | Y | 15AIMP033 | 104504 | 600 | UG | TABLET | BID | ||
| 127161071 | 12716107 | 8 | SS | SELEXIPAG | SELEXIPAG | 1 | Oral | 600 ?G, BID | 111600 | UG | Y | 15AIMP033 | 207947 | 600 | UG | TABLET | BID | ||
| 127161071 | 12716107 | 9 | SS | SELEXIPAG | SELEXIPAG | 1 | Oral | 800 ?G, BID | 111600 | UG | Y | 15AIMP033 | 104504 | 800 | UG | TABLET | BID | ||
| 127161071 | 12716107 | 10 | SS | SELEXIPAG | SELEXIPAG | 1 | Oral | 800 ?G, BID | 111600 | UG | Y | 15AIMP033 | 207947 | 800 | UG | TABLET | BID | ||
| 127161071 | 12716107 | 11 | SS | SELEXIPAG | SELEXIPAG | 1 | Oral | 1000 ?G, BID | 111600 | UG | Y | 15AIMP033 | 104504 | 1000 | UG | TABLET | BID | ||
| 127161071 | 12716107 | 12 | SS | SELEXIPAG | SELEXIPAG | 1 | Oral | 1000 ?G, BID | 111600 | UG | Y | 15AIMP033 | 207947 | 1000 | UG | TABLET | BID | ||
| 127161071 | 12716107 | 13 | SS | SELEXIPAG | SELEXIPAG | 1 | Oral | 1200 ?G, BID | 111600 | UG | Y | 15AIMP033 | 104504 | 1200 | UG | TABLET | BID | ||
| 127161071 | 12716107 | 14 | SS | SELEXIPAG | SELEXIPAG | 1 | Oral | 1200 ?G, BID | 111600 | UG | Y | 15AIMP033 | 207947 | 1200 | UG | TABLET | BID | ||
| 127161071 | 12716107 | 15 | SS | WELLBUTRIN | BUPROPION HYDROCHLORIDE | 1 | Oral | 300 MG, QD | Y | U | 0 | 300 | MG | QD | |||||
| 127161071 | 12716107 | 16 | SS | LEVOFLOXACIN. | LEVOFLOXACIN | 1 | Oral | 750 MG, OD | 0 | 750 | MG | QD | |||||||
| 127161071 | 12716107 | 17 | C | AMBRISENTAN | AMBRISENTAN | 1 | UNK | U | 0 | ||||||||||
| 127161071 | 12716107 | 18 | C | DIGOXIN. | DIGOXIN | 1 | UNK | U | 0 | ||||||||||
| 127161071 | 12716107 | 19 | C | FUROSEMIDE. | FUROSEMIDE | 1 | UNK | U | 0 | ||||||||||
| 127161071 | 12716107 | 20 | C | TADALAFIL | TADALAFIL | 1 | UNK | U | 0 | ||||||||||
| 127161071 | 12716107 | 21 | C | WARFARIN | WARFARIN | 1 | UNK | U | 0 | ||||||||||
| 127161071 | 12716107 | 22 | C | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 127161071 | 12716107 | 23 | C | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 127161071 | 12716107 | 24 | C | TYLENOL PM | ACETAMINOPHENDIPHENHYDRAMINE | 1 | UNK | U | 0 | ||||||||||
| 127161071 | 12716107 | 25 | C | IMODIUM | LOPERAMIDE HYDROCHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 127161071 | 12716107 | 26 | C | MULTIVITAMIN | VITAMINS | 1 | UNK | U | 0 | ||||||||||
| 127161071 | 12716107 | 27 | C | VICKS DAYQUIL | DEXTROMETHORPHAN HYDROBROMIDEGUAIFENESIN | 1 | UNK | U | 0 | ||||||||||
| 127161071 | 12716107 | 28 | C | VICKS NYQUIL | ACETAMINOPHENDEXTROMETHORPHAN HYDROBROMIDEDOXYLAMINE SUCCINATE | 1 | UNK | U | 0 | ||||||||||
| 127161071 | 12716107 | 29 | C | TREPROSTINIL SODIUM | TREPROSTINIL SODIUM | 1 | UNK | Y | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127161071 | 12716107 | 1 | Pulmonary arterial hypertension |
| 127161071 | 12716107 | 2 | Pulmonary arterial hypertension |
| 127161071 | 12716107 | 15 | Product used for unknown indication |
| 127161071 | 12716107 | 16 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127161071 | 12716107 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127161071 | 12716107 | Acute sinusitis | |
| 127161071 | 12716107 | Concomitant disease aggravated | |
| 127161071 | 12716107 | Dyskinesia | |
| 127161071 | 12716107 | Generalised tonic-clonic seizure | |
| 127161071 | 12716107 | Loss of consciousness | |
| 127161071 | 12716107 | Nausea | |
| 127161071 | 12716107 | Presyncope | |
| 127161071 | 12716107 | Right ventricular failure | |
| 127161071 | 12716107 | Syncope | |
| 127161071 | 12716107 | Urinary tract infection | |
| 127161071 | 12716107 | Viral upper respiratory tract infection | |
| 127161071 | 12716107 | 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 |
|---|---|---|---|---|---|---|
| 127161071 | 12716107 | 1 | 20160629 | 20160714 | 0 | |
| 127161071 | 12716107 | 2 | 20160629 | 20160714 | 0 | |
| 127161071 | 12716107 | 3 | 20160420 | 20160427 | 0 | |
| 127161071 | 12716107 | 4 | 20160420 | 20160427 | 0 | |
| 127161071 | 12716107 | 5 | 20160428 | 20160503 | 0 | |
| 127161071 | 12716107 | 6 | 20160428 | 20160503 | 0 | |
| 127161071 | 12716107 | 7 | 20160504 | 20160524 | 0 | |
| 127161071 | 12716107 | 8 | 20160504 | 20160524 | 0 | |
| 127161071 | 12716107 | 9 | 20160525 | 20160531 | 0 | |
| 127161071 | 12716107 | 10 | 20160525 | 20160531 | 0 | |
| 127161071 | 12716107 | 11 | 20160601 | 20160607 | 0 | |
| 127161071 | 12716107 | 12 | 20160601 | 20160607 | 0 | |
| 127161071 | 12716107 | 13 | 20160608 | 20160628 | 0 | |
| 127161071 | 12716107 | 14 | 20160608 | 20160628 | 0 | |
| 127161071 | 12716107 | 15 | 20130222 | 0 | ||
| 127161071 | 12716107 | 16 | 20160714 | 20160714 | 0 | |
| 127161071 | 12716107 | 17 | 20130329 | 0 | ||
| 127161071 | 12716107 | 18 | 20130222 | 0 | ||
| 127161071 | 12716107 | 19 | 20130222 | 0 | ||
| 127161071 | 12716107 | 20 | 20130222 | 0 | ||
| 127161071 | 12716107 | 21 | 20130222 | 0 | ||
| 127161071 | 12716107 | 22 | 2004 | 0 | ||
| 127161071 | 12716107 | 23 | 1998 | 0 | ||
| 127161071 | 12716107 | 24 | 20160504 | 0 | ||
| 127161071 | 12716107 | 25 | 20160504 | 0 | ||
| 127161071 | 12716107 | 26 | 20160627 | 0 | ||
| 127161071 | 12716107 | 27 | 20160706 | 0 | ||
| 127161071 | 12716107 | 28 | 20160706 | 0 | ||
| 127161071 | 12716107 | 29 | 20160614 | 0 |