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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 914733216 | 9147332 | 16 | F | 201402 | 20160726 | 20130307 | 20160802 | EXP | US-GLAXOSMITHKLINE-A1011853A | GLAXOSMITHKLINE | 47.17 | YR | F | Y | 73.50000 | KG | 20160802 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 914733216 | 9147332 | 1 | PS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 99 NG/KG/MINUTE CONTINUOUSLYVIAL STRENGTH: 1.5 MG80 NG/KG/MIN, 105,000 NG/ML, 83 ML/DAY, 1.5 MG[...] | N307 | 20444 | 99 | DF | POWDER FOR INFUSION | ||||||
| 914733216 | 9147332 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | P057 | 20444 | POWDER FOR INFUSION | |||||||||
| 914733216 | 9147332 | 3 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | R271A | 20444 | POWDER FOR INFUSION | |||||||||
| 914733216 | 9147332 | 4 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | R852 | 20444 | POWDER FOR INFUSION | |||||||||
| 914733216 | 9147332 | 5 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | R614 | 20444 | POWDER FOR INFUSION | |||||||||
| 914733216 | 9147332 | 6 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | S553 | 20444 | POWDER FOR INFUSION | |||||||||
| 914733216 | 9147332 | 7 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 78 NG/KG/MIN, CO | T366 | 20444 | POWDER FOR INFUSION | |||||||||
| 914733216 | 9147332 | 8 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 78 NG/KG/MIN, CO | T662 | 20444 | POWDER FOR INFUSION | |||||||||
| 914733216 | 9147332 | 9 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 78 NG/KG/MIN, CO | T620 | 20444 | POWDER FOR INFUSION | |||||||||
| 914733216 | 9147332 | 10 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 78 NG/KG/MIN, CO | U631 | 20444 | POWDER FOR INFUSION | |||||||||
| 914733216 | 9147332 | 11 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 76 DF, CO | Z111 | 20444 | 76 | DF | POWDER FOR INFUSION | |||||||
| 914733216 | 9147332 | 12 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 76 NG/KG/MIN, CO (VIAL STENGTH 1.5MG) | Z606 | 20444 | POWDER FOR INFUSION | |||||||||
| 914733216 | 9147332 | 13 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | UNKNOWN | 0 | SOLUTION FOR INJECTION | ||||||||
| 914733216 | 9147332 | 14 | SS | HYDROCORTISONE. | HYDROCORTISONE | 1 | Oral | 0 | 15 | MG | TABLET | BID | |||||||
| 914733216 | 9147332 | 15 | SS | SILDENAFIL CITRATE. | SILDENAFIL CITRATE | 1 | Y | 0 | |||||||||||
| 914733216 | 9147332 | 16 | SS | HYDROXYUREA. | HYDROXYUREA | 1 | Oral | 100 MG, QD | U | UNKNOWN | 0 | 100 | MG | QD | |||||
| 914733216 | 9147332 | 17 | C | TRACLEER | BOSENTAN | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 914733216 | 9147332 | 1 | Pulmonary arterial hypertension |
| 914733216 | 9147332 | 13 | Pulmonary arterial hypertension |
| 914733216 | 9147332 | 14 | Product used for unknown indication |
| 914733216 | 9147332 | 15 | Product used for unknown indication |
| 914733216 | 9147332 | 16 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 914733216 | 9147332 | HO |
| 914733216 | 9147332 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 914733216 | 9147332 | Abdominal pain upper | |
| 914733216 | 9147332 | Blood potassium increased | |
| 914733216 | 9147332 | Catheter site infection | |
| 914733216 | 9147332 | Central venous catheterisation | |
| 914733216 | 9147332 | Contusion | |
| 914733216 | 9147332 | Cystitis | |
| 914733216 | 9147332 | Dehydration | |
| 914733216 | 9147332 | Device related infection | |
| 914733216 | 9147332 | Device related sepsis | |
| 914733216 | 9147332 | Dizziness | |
| 914733216 | 9147332 | Headache | |
| 914733216 | 9147332 | Hospitalisation | |
| 914733216 | 9147332 | Lymphoma | |
| 914733216 | 9147332 | Medical device removal | |
| 914733216 | 9147332 | Nasopharyngitis | |
| 914733216 | 9147332 | Nausea | |
| 914733216 | 9147332 | Platelet count decreased | |
| 914733216 | 9147332 | Red blood cell count decreased | |
| 914733216 | 9147332 | Retching | |
| 914733216 | 9147332 | Syncope | |
| 914733216 | 9147332 | Treatment noncompliance | |
| 914733216 | 9147332 | Vomiting | |
| 914733216 | 9147332 | White blood cell count decreased |
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 |
|---|---|---|---|---|---|---|
| 914733216 | 9147332 | 1 | 20060214 | 0 | ||
| 914733216 | 9147332 | 2 | 20060215 | 0 | ||
| 914733216 | 9147332 | 3 | 20060215 | 0 | ||
| 914733216 | 9147332 | 4 | 20060215 | 0 | ||
| 914733216 | 9147332 | 5 | 20060215 | 0 | ||
| 914733216 | 9147332 | 6 | 20060215 | 0 | ||
| 914733216 | 9147332 | 11 | 20060214 | 0 | ||
| 914733216 | 9147332 | 12 | 20060214 | 0 |