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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120916506 | 12091650 | 6 | F | 20151005 | 20160912 | 20160218 | 20160916 | PER | US-GILEAD-2016-0198792 | GILEAD | 5.00 | YR | C | M | Y | 0.00000 | 20160916 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120916506 | 12091650 | 1 | PS | AMBRISENTAN | AMBRISENTAN | 1 | Unknown | UNK | U | 22081 | TABLET | ||||||||
| 120916506 | 12091650 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Unknown | CONCENTRATION: 45,000 NG/MLPUMP RATE: 74 ML/DAYVIAL STRENGTH: 1.5 MG140 NG/KG/ MIN45000 NG/MLVI[...] | U | P061 | 0 | 134 | DF | ||||||
| 120916506 | 12091650 | 3 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 162NG/KG/MIN, 1.5MG VIAL STR, 60,000NG/ML CONC, 80 ML/DAY RATE | U | T366 | 0 | ||||||||
| 120916506 | 12091650 | 4 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 174 DF (CONCENTRATION 60,000 NG/ML, PUMP RATE 86 ML/DAY, VIAL STRENGTH 1.5 MG), UNK | U | V378 | 0 | 174 | DF | ||||||
| 120916506 | 12091650 | 5 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 180 NG/KG/MIN , CO | U | V785 | 0 | 180 | DF | ||||||
| 120916506 | 12091650 | 6 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 190 NG/KG/MIN, 1.5 MG VIAL STRENGTH, 60,000 NG/ML CONCENTRATION, 93 ML/DAY RATE | U | Z880 | 0 | 190 | DF | ||||||
| 120916506 | 12091650 | 7 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | P193 | 0 | |||||||||
| 120916506 | 12091650 | 8 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | S553 | 0 | |||||||||
| 120916506 | 12091650 | 9 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Unknown | UNK UNK, CO | U | C769109 | 0 | ||||||||
| 120916506 | 12091650 | 10 | C | TRACLEER | BOSENTAN | 1 | U | 0 | |||||||||||
| 120916506 | 12091650 | 11 | C | SILDENAFIL. | SILDENAFIL | 1 | U | 0 | |||||||||||
| 120916506 | 12091650 | 12 | C | REVATIO | SILDENAFIL CITRATE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120916506 | 12091650 | 1 | Product used for unknown indication |
| 120916506 | 12091650 | 2 | Pulmonary arterial hypertension |
| 120916506 | 12091650 | 9 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120916506 | 12091650 | HO |
| 120916506 | 12091650 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120916506 | 12091650 | Catheter site erythema | |
| 120916506 | 12091650 | Catheterisation cardiac | |
| 120916506 | 12091650 | Central venous catheterisation | |
| 120916506 | 12091650 | Cerebrovascular accident | |
| 120916506 | 12091650 | Colonoscopy | |
| 120916506 | 12091650 | Device issue | |
| 120916506 | 12091650 | Device related infection | |
| 120916506 | 12091650 | Haemoglobin decreased | |
| 120916506 | 12091650 | Haemorrhage | |
| 120916506 | 12091650 | Headache | |
| 120916506 | 12091650 | Infusion site infection | |
| 120916506 | 12091650 | Malaise | |
| 120916506 | 12091650 | Off label use | |
| 120916506 | 12091650 | Sinus congestion | |
| 120916506 | 12091650 | Sinusitis |
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 |
|---|---|---|---|---|---|---|
| 120916506 | 12091650 | 2 | 20080718 | 0 | ||
| 120916506 | 12091650 | 6 | 20121003 | 0 |