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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116244334 | 11624433 | 4 | F | 2015 | 20160801 | 20151013 | 20160811 | EXP | JP-UNITED THERAPEUTICS-UNT-2015-001747 | UNITED THERAPEUTICS | 23.07 | YR | F | Y | 51.00000 | KG | 20160811 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116244334 | 11624433 | 1 | PS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 0.006 ?G/KG, CONTINUING | Y | 21272 | .006 | UG/KG | INJECTION | ||||||
| 116244334 | 11624433 | 2 | SS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | UNK | Y | 21272 | INJECTION | ||||||||
| 116244334 | 11624433 | 3 | SS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | UNK | Y | 21272 | INJECTION | ||||||||
| 116244334 | 11624433 | 4 | SS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | 0.018 ?G/KG, CONTINUING | Y | 21272 | .018 | UG/KG | INJECTION | ||||||
| 116244334 | 11624433 | 5 | C | LANIRAPID | METILDIGOXIN | 1 | Oral | 0.05 MG, QD | 0 | .05 | MG | QD | |||||||
| 116244334 | 11624433 | 6 | C | DIART | AZOSEMIDE | 1 | Oral | 60 MG, QD | 0 | 60 | MG | QD | |||||||
| 116244334 | 11624433 | 7 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | Oral | 25 MG, QD | 0 | 25 | MG | QD | |||||||
| 116244334 | 11624433 | 8 | C | ALOSITOL | ALLOPURINOL | 1 | Oral | 100 MG, QD | 0 | 100 | MG | QD | |||||||
| 116244334 | 11624433 | 9 | C | TRACLEER | BOSENTAN | 1 | Oral | 250 MG, QD | 0 | 250 | MG | QD | |||||||
| 116244334 | 11624433 | 10 | C | TRACLEER | BOSENTAN | 1 | 0 | ||||||||||||
| 116244334 | 11624433 | 11 | C | ADCIRCA | TADALAFIL | 1 | Oral | 40 MG, QD | 0 | 40 | MG | QD | |||||||
| 116244334 | 11624433 | 12 | C | ADCIRCA | TADALAFIL | 1 | 0 | ||||||||||||
| 116244334 | 11624433 | 13 | C | TAKEPRON | LANSOPRAZOLE | 1 | Oral | 15 MG, QD | 0 | 15 | MG | QD | |||||||
| 116244334 | 11624433 | 14 | C | THYRADIN S | LEVOTHYROXINE SODIUM | 1 | Oral | 12.5 ?G, QD | 0 | 12.5 | UG | QD | |||||||
| 116244334 | 11624433 | 15 | C | THYRADIN S | LEVOTHYROXINE SODIUM | 1 | Oral | 25 ?G, QD | 0 | 25 | UG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116244334 | 11624433 | 1 | Pulmonary arterial hypertension |
| 116244334 | 11624433 | 2 | Connective tissue disorder |
| 116244334 | 11624433 | 3 | Sjogren's syndrome |
| 116244334 | 11624433 | 5 | Right ventricular failure |
| 116244334 | 11624433 | 6 | Right ventricular failure |
| 116244334 | 11624433 | 7 | Right ventricular failure |
| 116244334 | 11624433 | 8 | Hyperuricaemia |
| 116244334 | 11624433 | 9 | Pulmonary arterial hypertension |
| 116244334 | 11624433 | 10 | Sjogren's syndrome |
| 116244334 | 11624433 | 11 | Pulmonary arterial hypertension |
| 116244334 | 11624433 | 12 | Sjogren's syndrome |
| 116244334 | 11624433 | 13 | Gastrooesophageal reflux disease |
| 116244334 | 11624433 | 14 | Thyroiditis chronic |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116244334 | 11624433 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116244334 | 11624433 | Chest discomfort | |
| 116244334 | 11624433 | Dermatitis contact | |
| 116244334 | 11624433 | Diarrhoea | |
| 116244334 | 11624433 | Dizziness | |
| 116244334 | 11624433 | Dysphoria | |
| 116244334 | 11624433 | Flushing | |
| 116244334 | 11624433 | Generalised erythema | |
| 116244334 | 11624433 | Infusion site cellulitis | |
| 116244334 | 11624433 | Infusion site discolouration | |
| 116244334 | 11624433 | Infusion site erosion | |
| 116244334 | 11624433 | Infusion site erythema | |
| 116244334 | 11624433 | Infusion site induration | |
| 116244334 | 11624433 | Infusion site inflammation | |
| 116244334 | 11624433 | Infusion site oedema | |
| 116244334 | 11624433 | Infusion site pain | |
| 116244334 | 11624433 | Infusion site pruritus | |
| 116244334 | 11624433 | Infusion site vesicles | |
| 116244334 | 11624433 | Infusion site warmth | |
| 116244334 | 11624433 | Malaise | |
| 116244334 | 11624433 | Menorrhagia | |
| 116244334 | 11624433 | Nausea | |
| 116244334 | 11624433 | Pain in jaw | |
| 116244334 | 11624433 | Pruritus generalised | |
| 116244334 | 11624433 | Pyrexia | |
| 116244334 | 11624433 | Type IV hypersensitivity reaction | |
| 116244334 | 11624433 | Urine output 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 |
|---|---|---|---|---|---|---|
| 116244334 | 11624433 | 1 | 20150205 | 20150622 | 0 | |
| 116244334 | 11624433 | 2 | 20150618 | 0 | ||
| 116244334 | 11624433 | 3 | 20150623 | 20150720 | 0 | |
| 116244334 | 11624433 | 5 | 20130529 | 0 | ||
| 116244334 | 11624433 | 6 | 20130528 | 0 | ||
| 116244334 | 11624433 | 7 | 20130528 | 0 | ||
| 116244334 | 11624433 | 8 | 20130528 | 0 | ||
| 116244334 | 11624433 | 9 | 20130529 | 0 | ||
| 116244334 | 11624433 | 11 | 20130919 | 0 | ||
| 116244334 | 11624433 | 13 | 20140320 | 0 |