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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1009203115 | 10092031 | 15 | F | 20160830 | 20140421 | 20160908 | EXP | US-GILEAD-2013-0071916 | GILEAD | 44.00 | YR | A | F | Y | 0.00000 | 20160908 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1009203115 | 10092031 | 1 | PS | LETAIRIS | AMBRISENTAN | 1 | Unknown | UNK | U | 22081 | TABLET | ||||||||
| 1009203115 | 10092031 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 221 NG/KG/MIN, CONTINUOUSLY, 1.5 MG VIAL STRENGTH, 45,000 NG/ML CONCENTRATION | U | N437 | 0 | 21 | DF | ||||||
| 1009203115 | 10092031 | 3 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | UNK | U | S501 | 0 | ||||||||
| 1009203115 | 10092031 | 4 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | UNK | U | S562 | 0 | 21 | DF | ||||||
| 1009203115 | 10092031 | 5 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 21 NG/KG/MIN, CONTINUOUSLY, 1.5 MG VIAL STRENGTH, 45,000 NG/ML CONCENTRATION | U | S706 | 0 | 21 | DF | ||||||
| 1009203115 | 10092031 | 6 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 21 NG/KG/MIN, CONTINUOUSLY, 1.5 MG VIAL STRENGTH, 45,000 NG/ML CONCENTRATION | U | V049 | 0 | 21 | DF | ||||||
| 1009203115 | 10092031 | 7 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 21 NG/KG/MIN, CONTINUOUSLY, 1.5 MG VIAL STRENGTH, 45,000 NG/ML CONCENTRATION | U | Z880 | 0 | 21 | DF | ||||||
| 1009203115 | 10092031 | 8 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | UNK | U | C764454 | 0 | ||||||||
| 1009203115 | 10092031 | 9 | SS | COUMADIN | WARFARIN SODIUM | 1 | Unknown | UNK | U | 0 | |||||||||
| 1009203115 | 10092031 | 10 | SS | ADCIRCA | TADALAFIL | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1009203115 | 10092031 | 1 | Product used for unknown indication |
| 1009203115 | 10092031 | 2 | Pulmonary arterial hypertension |
| 1009203115 | 10092031 | 8 | Pulmonary arterial hypertension |
| 1009203115 | 10092031 | 9 | Product used for unknown indication |
| 1009203115 | 10092031 | 10 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1009203115 | 10092031 | OT |
| 1009203115 | 10092031 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1009203115 | 10092031 | Anaemia | |
| 1009203115 | 10092031 | Anxiety | |
| 1009203115 | 10092031 | Application site erythema | |
| 1009203115 | 10092031 | Application site reaction | |
| 1009203115 | 10092031 | Asthenia | |
| 1009203115 | 10092031 | Asthma | |
| 1009203115 | 10092031 | Catheter site discharge | |
| 1009203115 | 10092031 | Device dislocation | |
| 1009203115 | 10092031 | Drug dose omission | |
| 1009203115 | 10092031 | Ear infection | |
| 1009203115 | 10092031 | Erythema | |
| 1009203115 | 10092031 | Fatigue | |
| 1009203115 | 10092031 | Flushing | |
| 1009203115 | 10092031 | Haemoglobin decreased | |
| 1009203115 | 10092031 | Pain | |
| 1009203115 | 10092031 | Surgery | |
| 1009203115 | 10092031 | Tachycardia | |
| 1009203115 | 10092031 | Thyroidectomy | |
| 1009203115 | 10092031 | Upper respiratory tract infection |
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 |
|---|---|---|---|---|---|---|
| 1009203115 | 10092031 | 2 | 19980106 | 0 | ||
| 1009203115 | 10092031 | 3 | 19990503 | 0 | ||
| 1009203115 | 10092031 | 4 | 19990503 | 0 |