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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112097788 | 11209778 | 8 | F | 201506 | 20160908 | 20150622 | 20160921 | EXP | JP-UNITED THERAPEUTICS-UNT-2015-007010 | UNITED THERAPEUTICS | 26.32 | YR | F | Y | 45.00000 | KG | 20160921 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112097788 | 11209778 | 1 | PS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | 0.002 ?G/KG, CONTINUING | Y | 21272 | .002 | UG/KG | INJECTION | ||||||
| 112097788 | 11209778 | 2 | SS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | UNK | Y | 21272 | INJECTION | ||||||||
| 112097788 | 11209778 | 3 | SS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 0.016 ?G/KG, CONTINUING | Y | 21272 | .016 | UG/KG | INJECTION | ||||||
| 112097788 | 11209778 | 4 | SS | TRAMCET | ACETAMINOPHENTRAMADOL | 1 | Unknown | Y | 0 | ||||||||||
| 112097788 | 11209778 | 5 | C | REVATIO | SILDENAFIL CITRATE | 1 | Oral | UNK | 0 | ||||||||||
| 112097788 | 11209778 | 6 | C | NITRIC OXIDE. | NITRIC OXIDE | 1 | UNK | 0 | |||||||||||
| 112097788 | 11209778 | 7 | C | MIDAZOLAM | MIDAZOLAMMIDAZOLAM HYDROCHLORIDE | 1 | UNK | 0 | |||||||||||
| 112097788 | 11209778 | 8 | C | FENTANYL. | FENTANYL | 1 | UNK | 0 | |||||||||||
| 112097788 | 11209778 | 9 | C | FENTANYL. | FENTANYL | 1 | Intravenous drip | UNK | 0 | ||||||||||
| 112097788 | 11209778 | 10 | C | REMIFENTANIL HYDROCHLORIDE | REMIFENTANIL HYDROCHLORIDE | 1 | Intravenous drip | UNK | 0 | ||||||||||
| 112097788 | 11209778 | 11 | C | PROPOFOL. | PROPOFOL | 1 | Intravenous drip | UNK | 0 | ||||||||||
| 112097788 | 11209778 | 12 | C | DEXMEDETOMIDINE HYDROCHLORIDE. | DEXMEDETOMIDINE HYDROCHLORIDE | 1 | Intravenous drip | UNK | 0 | ||||||||||
| 112097788 | 11209778 | 13 | C | NITROGLYCERIN. | NITROGLYCERIN | 1 | UNK | 0 | |||||||||||
| 112097788 | 11209778 | 14 | C | CARPERITIDE | CARPERITIDE | 1 | Intravenous drip | UNK | 0 | ||||||||||
| 112097788 | 11209778 | 15 | C | VOLIBRIS | AMBRISENTAN | 1 | Oral | UNK | 0 | ||||||||||
| 112097788 | 11209778 | 16 | C | PROCYLIN | BERAPROST SODIUM | 1 | Oral | UNK | 0 | ||||||||||
| 112097788 | 11209778 | 17 | C | ADEMPAS | RIOCIGUAT | 1 | Oral | UNK | 0 | ||||||||||
| 112097788 | 11209778 | 18 | C | FUROSEMIDE. | FUROSEMIDE | 1 | UNK | 0 | |||||||||||
| 112097788 | 11209778 | 19 | C | TAKEPRON | LANSOPRAZOLE | 1 | Oral | UNK | 0 | ||||||||||
| 112097788 | 11209778 | 20 | C | LOXONIN | LOXOPROFEN SODIUM | 1 | UNK | 0 | |||||||||||
| 112097788 | 11209778 | 21 | C | MOBIC | MELOXICAM | 1 | Oral | UNK | 0 | ||||||||||
| 112097788 | 11209778 | 22 | C | BROTIZOLAM | BROTIZOLAM | 1 | Oral | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 112097788 | 11209778 | 1 | Pulmonary arterial hypertension |
| 112097788 | 11209778 | 4 | Product used for unknown indication |
| 112097788 | 11209778 | 5 | Pulmonary arterial hypertension |
| 112097788 | 11209778 | 6 | Pulmonary arterial hypertension |
| 112097788 | 11209778 | 7 | General anaesthesia |
| 112097788 | 11209778 | 8 | General anaesthesia |
| 112097788 | 11209778 | 9 | Analgesic therapy |
| 112097788 | 11209778 | 10 | General anaesthesia |
| 112097788 | 11209778 | 11 | General anaesthesia |
| 112097788 | 11209778 | 12 | Sedation |
| 112097788 | 11209778 | 13 | Product used for unknown indication |
| 112097788 | 11209778 | 14 | Product used for unknown indication |
| 112097788 | 11209778 | 15 | Pulmonary arterial hypertension |
| 112097788 | 11209778 | 16 | Pulmonary arterial hypertension |
| 112097788 | 11209778 | 17 | Product used for unknown indication |
| 112097788 | 11209778 | 18 | Pulmonary arterial hypertension |
| 112097788 | 11209778 | 19 | Prophylaxis |
| 112097788 | 11209778 | 20 | Analgesic therapy |
| 112097788 | 11209778 | 21 | Analgesic therapy |
| 112097788 | 11209778 | 22 | Insomnia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 112097788 | 11209778 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 112097788 | 11209778 | Ear discomfort | |
| 112097788 | 11209778 | Infusion site erythema | |
| 112097788 | 11209778 | Infusion site induration | |
| 112097788 | 11209778 | Infusion site pain | |
| 112097788 | 11209778 | Infusion site swelling | |
| 112097788 | 11209778 | Infusion site warmth | |
| 112097788 | 11209778 | Maternal exposure during delivery | |
| 112097788 | 11209778 | Nausea |
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 |
|---|---|---|---|---|---|---|
| 112097788 | 11209778 | 1 | 20150603 | 20150619 | 0 | |
| 112097788 | 11209778 | 2 | 20150615 | 20150627 | 0 | |
| 112097788 | 11209778 | 5 | 2015 | 0 | ||
| 112097788 | 11209778 | 6 | 20150603 | 20150603 | 0 | |
| 112097788 | 11209778 | 7 | 20150603 | 20150603 | 0 | |
| 112097788 | 11209778 | 8 | 20150603 | 20150603 | 0 | |
| 112097788 | 11209778 | 9 | 20150603 | 0 | ||
| 112097788 | 11209778 | 10 | 20150603 | 20150603 | 0 | |
| 112097788 | 11209778 | 11 | 20150603 | 20150603 | 0 | |
| 112097788 | 11209778 | 12 | 20150603 | 0 | ||
| 112097788 | 11209778 | 13 | 20150603 | 0 | ||
| 112097788 | 11209778 | 14 | 20150603 | 0 |