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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124345053 | 12434505 | 3 | F | 20160228 | 20160613 | 20160603 | 20160729 | EXP | US-ACTELION-A-NJ2015-127544 | ACTELION | 50.00 | YR | A | F | Y | 0.00000 | 20160729 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124345053 | 12434505 | 1 | PS | VELETRI | EPOPROSTENOL | 1 | Intravenous (not otherwise specified) | 3.5 NG/KG, PER MIN | LM009M0601, LM010M0301, MM081M0101 | 22260 | INJECTION | /min | |||||||
| 124345053 | 12434505 | 2 | SS | VELETRI | EPOPROSTENOL | 1 | Intravenous (not otherwise specified) | UNK | LM010M0301, MM067M0101, MM077M0101, | 22260 | INJECTION | ||||||||
| 124345053 | 12434505 | 3 | SS | CELEXA | CITALOPRAM HYDROBROMIDE | 1 | Unknown | U | U | 0 | |||||||||
| 124345053 | 12434505 | 4 | C | REVATIO | SILDENAFIL CITRATE | 1 | U | 0 | |||||||||||
| 124345053 | 12434505 | 5 | C | ADCIRCA | TADALAFIL | 1 | U | 0 | |||||||||||
| 124345053 | 12434505 | 6 | C | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | 10 MG, UNK | U | 0 | 10 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124345053 | 12434505 | 1 | Pulmonary hypertension |
| 124345053 | 12434505 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124345053 | 12434505 | DE |
| 124345053 | 12434505 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124345053 | 12434505 | Abdominal pain | |
| 124345053 | 12434505 | Abdominal pain upper | |
| 124345053 | 12434505 | Ascites | |
| 124345053 | 12434505 | Back pain | |
| 124345053 | 12434505 | Complication associated with device | |
| 124345053 | 12434505 | Constipation | |
| 124345053 | 12434505 | Death | |
| 124345053 | 12434505 | Decreased appetite | |
| 124345053 | 12434505 | Dizziness | |
| 124345053 | 12434505 | Dyspnoea | |
| 124345053 | 12434505 | Feeling hot | |
| 124345053 | 12434505 | Fluid retention | |
| 124345053 | 12434505 | Headache | |
| 124345053 | 12434505 | Internal haemorrhage | |
| 124345053 | 12434505 | Musculoskeletal chest pain | |
| 124345053 | 12434505 | Musculoskeletal discomfort | |
| 124345053 | 12434505 | Nausea | |
| 124345053 | 12434505 | Oedema | |
| 124345053 | 12434505 | Oedema peripheral | |
| 124345053 | 12434505 | Pain in jaw | |
| 124345053 | 12434505 | Transplant evaluation | |
| 124345053 | 12434505 | Weight decreased | |
| 124345053 | 12434505 | Weight increased | |
| 124345053 | 12434505 | Wheezing |
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 |
|---|---|---|---|---|---|---|
| 124345053 | 12434505 | 1 | 20151109 | 20160610 | 0 |