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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124448592 | 12444859 | 2 | F | 20160524 | 20160622 | 20160607 | 20160712 | PER | US-ACTELION-A-NJ2016-137065 | ACTELION | 66.00 | YR | E | F | Y | 113.38000 | KG | 20160712 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124448592 | 12444859 | 1 | PS | OPSUMIT | MACITENTAN | 1 | Oral | 10 MG, QD | 204410 | 10 | MG | TABLET | QD | ||||||
| 124448592 | 12444859 | 2 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 3 TABLETS FOR 3 DAYS | 0 | ||||||||||
| 124448592 | 12444859 | 3 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 2 TABLETS FOR 3 DAYS | 0 | ||||||||||
| 124448592 | 12444859 | 4 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 1 TABLETS FOR 3 DAYS | 0 | ||||||||||
| 124448592 | 12444859 | 5 | C | LASIX | FUROSEMIDE | 1 | 40 MG, BID | U | 0 | 40 | MG | BID | |||||||
| 124448592 | 12444859 | 6 | C | TYVASO | TREPROSTINIL | 1 | 12 PUFF, QID | U | 0 | QID | |||||||||
| 124448592 | 12444859 | 7 | C | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | 50 MG, QD | U | 0 | 50 | MG | QD | |||||||
| 124448592 | 12444859 | 8 | C | LOSARTAN. | LOSARTAN | 1 | 50 MG, QD | U | 0 | 50 | MG | QD | |||||||
| 124448592 | 12444859 | 9 | C | ALLOPURINOL. | ALLOPURINOL | 1 | 200 MG, QD | U | 0 | 200 | MG | QD | |||||||
| 124448592 | 12444859 | 10 | C | METOLAZONE. | METOLAZONE | 1 | 4 MG, QD | U | 0 | 4 | MG | QD | |||||||
| 124448592 | 12444859 | 11 | C | ROPINIROLE. | ROPINIROLE | 1 | 4 MG, QD | U | 0 | 4 | MG | QD | |||||||
| 124448592 | 12444859 | 12 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | 20 MG, QD | U | 0 | 20 | MG | QD | |||||||
| 124448592 | 12444859 | 13 | C | COUMADIN | WARFARIN SODIUM | 1 | 7.25 MG, QD | U | 0 | 7.25 | MG | QD | |||||||
| 124448592 | 12444859 | 14 | C | COUMADIN | WARFARIN SODIUM | 1 | 3.625 MG, Q1WEEK | U | 0 | 3.625 | MG | /wk | |||||||
| 124448592 | 12444859 | 15 | C | MYRBETRIQ | MIRABEGRON | 1 | 50 MG, QD | U | 0 | 50 | MG | QD | |||||||
| 124448592 | 12444859 | 16 | C | MYRBETRIQ | MIRABEGRON | 1 | 5 UNK, UNK | U | 0 | 5 | MG | QD | |||||||
| 124448592 | 12444859 | 17 | C | SLOW MAG | MAGNESIUM CHLORIDE | 1 | UNK | U | 0 | ||||||||||
| 124448592 | 12444859 | 18 | C | FISH OIL | FISH OIL | 1 | UNK | U | 0 | ||||||||||
| 124448592 | 12444859 | 19 | C | VITAMIN C | ASCORBIC ACID | 1 | UNK | U | 0 | ||||||||||
| 124448592 | 12444859 | 20 | C | CALCIUM | CALCIUM | 1 | UNK | U | 0 | ||||||||||
| 124448592 | 12444859 | 21 | C | IRON | IRON | 1 | UNK | U | 0 | ||||||||||
| 124448592 | 12444859 | 22 | C | CALCIUM + VITAMIN D | CALCIUMVITAMIN D | 1 | UNK | U | 0 | ||||||||||
| 124448592 | 12444859 | 23 | C | POTASSIUM | POTASSIUM | 1 | UNK | U | 0 | ||||||||||
| 124448592 | 12444859 | 24 | C | VITAMIN D | CHOLECALCIFEROL | 1 | U | 0 | |||||||||||
| 124448592 | 12444859 | 25 | C | PROZAC | FLUOXETINE HYDROCHLORIDE | 1 | N | 0 | |||||||||||
| 124448592 | 12444859 | 26 | C | VESICARE | SOLIFENACIN SUCCINATE | 1 | N | 0 | |||||||||||
| 124448592 | 12444859 | 27 | C | FLUTICASONE | FLUTICASONEFLUTICASONE PROPIONATE | 1 | UNK, QD | U | 0 | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124448592 | 12444859 | 1 | Pulmonary arterial hypertension |
| 124448592 | 12444859 | 2 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124448592 | 12444859 | Condition aggravated | |
| 124448592 | 12444859 | Oxygen saturation decreased | |
| 124448592 | 12444859 | Pulmonary arterial hypertension | |
| 124448592 | 12444859 | Renal impairment | |
| 124448592 | 12444859 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 124448592 | 12444859 | 1 | 20160520 | 0 | ||
| 124448592 | 12444859 | 2 | 20160519 | 0 | ||
| 124448592 | 12444859 | 6 | 201308 | 0 | ||
| 124448592 | 12444859 | 7 | 201603 | 0 | ||
| 124448592 | 12444859 | 8 | 2015 | 0 | ||
| 124448592 | 12444859 | 12 | 2000 | 0 | ||
| 124448592 | 12444859 | 13 | 200006 | 0 | ||
| 124448592 | 12444859 | 15 | 201604 | 0 |