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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123053434 | 12305343 | 4 | F | 20151215 | 20160809 | 20160426 | 20160812 | EXP | JP-GLAXOSMITHKLINE-JP2016JPN055141 | GLAXOSMITHKLINE | 61.08 | YR | M | Y | 76.00000 | KG | 20160812 | CN | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123053434 | 12305343 | 1 | PS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous drip | UNK | Y | 20444 | POWDER FOR INFUSION | ||||||||
| 123053434 | 12305343 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Y | 20444 | POWDER FOR INFUSION | ||||||||||
| 123053434 | 12305343 | 3 | SS | Ambrisentan | AMBRISENTAN | 1 | Oral | 5 MG, QD | 65 | MG | 0 | 5 | MG | TABLET | QD | ||||
| 123053434 | 12305343 | 4 | SS | Ambrisentan | AMBRISENTAN | 1 | Oral | 10 MG, QD | 65 | MG | 0 | 10 | MG | TABLET | QD | ||||
| 123053434 | 12305343 | 5 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | UNK | 0 | ||||||||||
| 123053434 | 12305343 | 6 | SS | SOL-MELCORT | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | UNK | 0 | |||||||||||
| 123053434 | 12305343 | 7 | SS | SOL-MELCORT | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | 0 | ||||||||||||
| 123053434 | 12305343 | 8 | SS | GLUCOSE | DEXTROSE | 1 | UNK | 0 | |||||||||||
| 123053434 | 12305343 | 9 | SS | GLUCOSE | DEXTROSE | 1 | 0 | ||||||||||||
| 123053434 | 12305343 | 10 | C | ADCIRCA | TADALAFIL | 1 | UNK | 0 | |||||||||||
| 123053434 | 12305343 | 11 | C | ADCIRCA | TADALAFIL | 1 | 0 | ||||||||||||
| 123053434 | 12305343 | 12 | C | BERASUS LA | 2 | UNK | 0 | ||||||||||||
| 123053434 | 12305343 | 13 | C | BERASUS LA | 2 | 0 | |||||||||||||
| 123053434 | 12305343 | 14 | C | REVATIO | SILDENAFIL CITRATE | 1 | UNK | 0 | |||||||||||
| 123053434 | 12305343 | 15 | C | REVATIO | SILDENAFIL CITRATE | 1 | 0 | ||||||||||||
| 123053434 | 12305343 | 16 | C | TREPROST | 2 | UNK | 0 | ||||||||||||
| 123053434 | 12305343 | 17 | C | TREPROST | 2 | 0 | |||||||||||||
| 123053434 | 12305343 | 18 | C | FUROSEMIDE. | FUROSEMIDE | 1 | UNK | 0 | |||||||||||
| 123053434 | 12305343 | 19 | C | SAMSCA | TOLVAPTAN | 1 | UNK | 0 | |||||||||||
| 123053434 | 12305343 | 20 | C | PARIET | RABEPRAZOLE SODIUM | 1 | UNK | 0 | |||||||||||
| 123053434 | 12305343 | 21 | C | BONALON | ALENDRONATE SODIUM | 1 | UNK | 0 | |||||||||||
| 123053434 | 12305343 | 22 | C | BAKTAR | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | UNK | 0 | |||||||||||
| 123053434 | 12305343 | 23 | C | FEBURIC | FEBUXOSTAT | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123053434 | 12305343 | 1 | Pulmonary veno-occlusive disease |
| 123053434 | 12305343 | 2 | Pulmonary hypertension |
| 123053434 | 12305343 | 3 | Pulmonary veno-occlusive disease |
| 123053434 | 12305343 | 4 | Pulmonary hypertension |
| 123053434 | 12305343 | 6 | Pulmonary veno-occlusive disease |
| 123053434 | 12305343 | 7 | Pulmonary hypertension |
| 123053434 | 12305343 | 8 | Pulmonary veno-occlusive disease |
| 123053434 | 12305343 | 9 | Pulmonary hypertension |
| 123053434 | 12305343 | 10 | Pulmonary veno-occlusive disease |
| 123053434 | 12305343 | 11 | Pulmonary hypertension |
| 123053434 | 12305343 | 12 | Pulmonary veno-occlusive disease |
| 123053434 | 12305343 | 13 | Pulmonary hypertension |
| 123053434 | 12305343 | 14 | Pulmonary veno-occlusive disease |
| 123053434 | 12305343 | 15 | Pulmonary hypertension |
| 123053434 | 12305343 | 16 | Pulmonary veno-occlusive disease |
| 123053434 | 12305343 | 17 | Pulmonary hypertension |
| 123053434 | 12305343 | 20 | Gastritis prophylaxis |
| 123053434 | 12305343 | 21 | Osteoporosis prophylaxis |
| 123053434 | 12305343 | 22 | Infection prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123053434 | 12305343 | DE |
| 123053434 | 12305343 | OT |
| 123053434 | 12305343 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123053434 | 12305343 | Cardiac failure | |
| 123053434 | 12305343 | Diarrhoea | |
| 123053434 | 12305343 | Haemoptysis | |
| 123053434 | 12305343 | Occult blood positive | |
| 123053434 | 12305343 | Platelet 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 |
|---|---|---|---|---|---|---|
| 123053434 | 12305343 | 1 | 20151225 | 20160329 | 0 | |
| 123053434 | 12305343 | 3 | 20150304 | 20150317 | 0 | |
| 123053434 | 12305343 | 4 | 20150318 | 0 | ||
| 123053434 | 12305343 | 5 | 20160331 | 0 | ||
| 123053434 | 12305343 | 6 | 20160329 | 20160331 | 0 | |
| 123053434 | 12305343 | 8 | 20160329 | 20160331 | 0 | |
| 123053434 | 12305343 | 10 | 20150226 | 0 | ||
| 123053434 | 12305343 | 12 | 20150812 | 0 | ||
| 123053434 | 12305343 | 14 | 20150512 | 0 | ||
| 123053434 | 12305343 | 16 | 20160329 | 0 | ||
| 123053434 | 12305343 | 18 | 20150227 | 0 | ||
| 123053434 | 12305343 | 19 | 20150812 | 0 | ||
| 123053434 | 12305343 | 21 | 20160401 | 0 | ||
| 123053434 | 12305343 | 22 | 20160331 | 0 | ||
| 123053434 | 12305343 | 23 | 20160109 | 0 |