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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125808262 | 12580826 | 2 | F | 20151115 | 20160720 | 20160721 | 20160729 | EXP | US-JNJFOC-20160714950 | JANSSEN | 47.23 | YR | A | F | Y | 71.70000 | KG | 20160729 | MD | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125808262 | 12580826 | 1 | PS | XARELTO | RIVAROXABAN | 1 | Oral | U | U | 22406 | 10 | MG | TABLET | QD | |||||
125808262 | 12580826 | 2 | SS | BAYER ASPIRIN | ASPIRIN | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
125808262 | 12580826 | 3 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | U | 2100399;1500226A;1500227A | 0 | 10 | MG | UNSPECIFIED | TID | |||||
125808262 | 12580826 | 4 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | U | 2100399;1500226A;1500227A | 0 | 2.5 | MG | UNSPECIFIED | ||||||
125808262 | 12580826 | 5 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | U | 2100399;1500226A;1500227A | 0 | 5 | MG | UNSPECIFIED | TID | |||||
125808262 | 12580826 | 6 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | U | 2100399;1500226A;1500227A | 0 | 7.5 | MG | UNSPECIFIED | Q8H | |||||
125808262 | 12580826 | 7 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | U | 2100399;1500226A;1500227A | 0 | 7.5 | MG | UNSPECIFIED | TID | |||||
125808262 | 12580826 | 8 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | U | 2100399;1500226A;1500227A | 0 | 2.5 | MG | UNSPECIFIED | TID | |||||
125808262 | 12580826 | 9 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | U | 2100399;1500226A;1500227A | 0 | 5 | MG | UNSPECIFIED | BID | |||||
125808262 | 12580826 | 10 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | U | 2100399;1500226A;1500227A | 0 | UNSPECIFIED | ||||||||
125808262 | 12580826 | 11 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | U | 2100399;1500226A;1500227A | 0 | 2.5 | MG | UNSPECIFIED | Q8H | |||||
125808262 | 12580826 | 12 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | U | 2100399;1500226A;1500227A | 0 | UNSPECIFIED | ||||||||
125808262 | 12580826 | 13 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | U | 2100399;1500226A;1500227A | 0 | 17.5 | MG | UNSPECIFIED | QD | |||||
125808262 | 12580826 | 14 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | U | 2100399;1500226A;1500227A | 0 | 17.5 | MG | UNSPECIFIED | QD | |||||
125808262 | 12580826 | 15 | SS | LETAIRIS | AMBRISENTAN | 1 | Oral | U | SBFW;1500226A;1500225A;1500227A | 0 | 10 | MG | UNSPECIFIED | QD | |||||
125808262 | 12580826 | 16 | SS | LETAIRIS | AMBRISENTAN | 1 | Oral | U | SBFW;1500226A;1500225A;1500227A | 0 | 10 | MG | UNSPECIFIED | ||||||
125808262 | 12580826 | 17 | SS | LETAIRIS | AMBRISENTAN | 1 | Oral | U | SBFW;1500226A;1500225A;1500227A | 0 | 10 | MG | UNSPECIFIED | QD | |||||
125808262 | 12580826 | 18 | SS | LETAIRIS | AMBRISENTAN | 1 | Oral | U | SBFW;1500226A;1500225A;1500227A | 0 | 10 | MG | UNSPECIFIED | QD | |||||
125808262 | 12580826 | 19 | SS | LETAIRIS | AMBRISENTAN | 1 | Oral | U | SBFW;1500226A;1500225A;1500227A | 0 | 10 | MG | UNSPECIFIED | QD | |||||
125808262 | 12580826 | 20 | SS | LETAIRIS | AMBRISENTAN | 1 | Oral | U | SBFW;1500226A;1500225A;1500227A | 0 | 10 | MG | UNSPECIFIED | QD | |||||
125808262 | 12580826 | 21 | SS | LETAIRIS | AMBRISENTAN | 1 | Oral | U | SBFW;1500226A;1500225A;1500227A | 0 | 10 | MG | UNSPECIFIED | ||||||
125808262 | 12580826 | 22 | SS | LETAIRIS | AMBRISENTAN | 1 | Oral | U | SBFW;1500226A;1500225A;1500227A | 0 | 10 | MG | UNSPECIFIED | QD | |||||
125808262 | 12580826 | 23 | SS | LETAIRIS | AMBRISENTAN | 1 | Oral | U | SBFW;1500226A;1500225A;1500227A | 0 | 10 | MG | UNSPECIFIED | QD | |||||
125808262 | 12580826 | 24 | SS | LETAIRIS | AMBRISENTAN | 1 | Oral | U | SBFW;1500226A;1500225A;1500227A | 0 | 10 | MG | UNSPECIFIED | QD | |||||
125808262 | 12580826 | 25 | SS | LETAIRIS | AMBRISENTAN | 1 | Oral | U | SBFW;1500226A;1500225A;1500227A | 0 | 10 | MG | UNSPECIFIED | QD | |||||
125808262 | 12580826 | 26 | SS | LETAIRIS | AMBRISENTAN | 1 | Oral | U | SBFW;1500226A;1500225A;1500227A | 0 | 10 | MG | UNSPECIFIED | QD | |||||
125808262 | 12580826 | 27 | SS | REVATIO | SILDENAFIL CITRATE | 1 | Oral | U | 0 | 60 | MG | UNSPECIFIED | TID | ||||||
125808262 | 12580826 | 28 | SS | METOLAZONE. | METOLAZONE | 1 | Oral | U | 0 | 5 | MG | UNSPECIFIED | QD | ||||||
125808262 | 12580826 | 29 | SS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | U | 926118 | 0 | .092 | IU/KG | UNSPECIFIED | ||||||
125808262 | 12580826 | 30 | C | PROMETHAZINE | PROMETHAZINEPROMETHAZINE HYDROCHLORIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
125808262 | 12580826 | 31 | C | SIMVASTATIN. | SIMVASTATIN | 1 | Oral | 0 | 10 | MG | UNSPECIFIED | QD | |||||||
125808262 | 12580826 | 32 | C | SIMVASTATIN. | SIMVASTATIN | 1 | Oral | 0 | 5 | MG | UNSPECIFIED | QD | |||||||
125808262 | 12580826 | 33 | C | BIOTIN | BIOTIN | 1 | Oral | 0 | 5000 | UG | UNSPECIFIED | QD | |||||||
125808262 | 12580826 | 34 | C | CELEBREX | CELECOXIB | 1 | Oral | 0 | 100 | MG | UNSPECIFIED | QD | |||||||
125808262 | 12580826 | 35 | C | DIGOXIN. | DIGOXIN | 1 | Oral | 0 | .125 | UG | UNSPECIFIED | QD | |||||||
125808262 | 12580826 | 36 | C | DIPHENHYDRAMINE. | DIPHENHYDRAMINE | 1 | Oral | 0 | 25 | MG | UNSPECIFIED | BID | |||||||
125808262 | 12580826 | 37 | C | FLUTICASONE | FLUTICASONEFLUTICASONE PROPIONATE | 1 | Topical | 0 | UNSPECIFIED | ||||||||||
125808262 | 12580826 | 38 | C | KLOR-CON | POTASSIUM CHLORIDE | 1 | Unknown | 0 | 20 | MEQ | UNSPECIFIED | TID | |||||||
125808262 | 12580826 | 39 | C | MELOXICAM. | MELOXICAM | 1 | Oral | 0 | 7.5 | MG | UNSPECIFIED | QD | |||||||
125808262 | 12580826 | 40 | C | PRILOSEC | OMEPRAZOLE MAGNESIUM | 1 | Oral | 0 | 40 | MG | UNSPECIFIED | BID | |||||||
125808262 | 12580826 | 41 | C | ONDANSETRON | ONDANSETRON | 1 | Oral | 0 | 40 | MG | UNSPECIFIED | QID | |||||||
125808262 | 12580826 | 42 | C | OXYGEN. | OXYGEN | 1 | Nasal | 0 | 2.5 | L | UNSPECIFIED | ||||||||
125808262 | 12580826 | 43 | C | REQUIP | ROPINIROLE HYDROCHLORIDE | 1 | Oral | 0 | .75 | MG | UNSPECIFIED | QD | |||||||
125808262 | 12580826 | 44 | C | ALDACTONE | SPIRONOLACTONE | 1 | Unknown | 0 | 100 | MG | UNSPECIFIED | QD | |||||||
125808262 | 12580826 | 45 | C | COLACE | DOCUSATE SODIUM | 1 | Oral | 0 | 250 | MG | UNSPECIFIED | BID | |||||||
125808262 | 12580826 | 46 | C | ASCORBIC ACID. | ASCORBIC ACID | 1 | Oral | 0 | 500 | MG | UNSPECIFIED | QD | |||||||
125808262 | 12580826 | 47 | C | IRON | IRON | 1 | Oral | 0 | 225 | MG | UNSPECIFIED | BID | |||||||
125808262 | 12580826 | 48 | C | RANITIDINE. | RANITIDINE | 1 | Unknown | 0 | 300 | MG | UNSPECIFIED | BID | |||||||
125808262 | 12580826 | 49 | C | ACIPHEX | RABEPRAZOLE SODIUM | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
125808262 | 12580826 | 50 | C | ATIVAN | LORAZEPAM | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
125808262 | 12580826 | 51 | C | SINEMET | CARBIDOPALEVODOPA | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
125808262 | 12580826 | 52 | C | INVANZ | ERTAPENEM SODIUM | 1 | Intravenous (not otherwise specified) | 0 | 1 | G | UNSPECIFIED | QD | |||||||
125808262 | 12580826 | 53 | C | TORSEMIDE. | TORSEMIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
125808262 | 12580826 | 54 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Oral | 0 | 100 | UG | UNSPECIFIED | QD | |||||||
125808262 | 12580826 | 55 | C | ELAVIL | AMITRIPTYLINE HYDROCHLORIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
125808262 | 12580826 | 56 | C | DEMADEX | TORSEMIDE | 1 | Unknown | 0 | 20 | MG | UNSPECIFIED | TID | |||||||
125808262 | 12580826 | 57 | C | CALCIUM | CALCIUM | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
125808262 | 12580826 | 58 | C | ALPRAZOLAM. | ALPRAZOLAM | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
125808262 | 12580826 | 59 | C | CYANOCOBALAMINE | CYANOCOBALAMIN | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
125808262 | 12580826 | 60 | C | MORPHINE HYDROCHLORIDE | MORPHINE HYDROCHLORIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
125808262 | 12580826 | 61 | C | VITAMIN B COMPLEX | CYANOCOBALAMINDEXPANTHENOLNIACINAMIDEPYRIDOXINE HYDROCHLORIDERIBOFLAVIN 5'-PHOSPHATE SODIUMTHIAMINE HYDROCHLORIDEVITAMIN B COMPLEX | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
125808262 | 12580826 | 62 | C | FERROUS GLUCONATE | FERROUS GLUCONATE | 1 | Unknown | 0 | 225 | MG | UNSPECIFIED | BID | |||||||
125808262 | 12580826 | 63 | C | TRAMADOL. | TRAMADOL | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
125808262 | 12580826 | 1 | Product used for unknown indication |
125808262 | 12580826 | 2 | Product used for unknown indication |
125808262 | 12580826 | 3 | Pulmonary hypertension |
125808262 | 12580826 | 4 | Pulmonary hypertension |
125808262 | 12580826 | 5 | Pulmonary hypertension |
125808262 | 12580826 | 6 | Pulmonary hypertension |
125808262 | 12580826 | 7 | Pulmonary hypertension |
125808262 | 12580826 | 8 | Pulmonary hypertension |
125808262 | 12580826 | 9 | Pulmonary hypertension |
125808262 | 12580826 | 10 | Pulmonary hypertension |
125808262 | 12580826 | 11 | Pulmonary hypertension |
125808262 | 12580826 | 12 | Pulmonary hypertension |
125808262 | 12580826 | 13 | Pulmonary hypertension |
125808262 | 12580826 | 14 | Pulmonary hypertension |
125808262 | 12580826 | 15 | Drug abuse |
125808262 | 12580826 | 16 | Drug abuse |
125808262 | 12580826 | 17 | Drug abuse |
125808262 | 12580826 | 18 | Drug abuse |
125808262 | 12580826 | 19 | Drug abuse |
125808262 | 12580826 | 20 | Drug abuse |
125808262 | 12580826 | 21 | Pulmonary hypertension |
125808262 | 12580826 | 22 | Pulmonary hypertension |
125808262 | 12580826 | 23 | Pulmonary hypertension |
125808262 | 12580826 | 24 | Pulmonary hypertension |
125808262 | 12580826 | 25 | Pulmonary hypertension |
125808262 | 12580826 | 26 | Pulmonary hypertension |
125808262 | 12580826 | 27 | Product used for unknown indication |
125808262 | 12580826 | 28 | Oedema |
125808262 | 12580826 | 29 | Pulmonary hypertension |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
125808262 | 12580826 | HO |
125808262 | 12580826 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
125808262 | 12580826 | Acute myocardial infarction | |
125808262 | 12580826 | Acute respiratory failure | |
125808262 | 12580826 | Adverse drug reaction | |
125808262 | 12580826 | Ascites | |
125808262 | 12580826 | Asthenia | |
125808262 | 12580826 | Bladder disorder | |
125808262 | 12580826 | Blood pressure decreased | |
125808262 | 12580826 | Cardiac failure acute | |
125808262 | 12580826 | Cellulitis | |
125808262 | 12580826 | Chest discomfort | |
125808262 | 12580826 | Chills | |
125808262 | 12580826 | Clostridium difficile infection | |
125808262 | 12580826 | Device occlusion | |
125808262 | 12580826 | Device related sepsis | |
125808262 | 12580826 | Dizziness | |
125808262 | 12580826 | Drug dose omission | |
125808262 | 12580826 | Drug intolerance | |
125808262 | 12580826 | Dyspnoea | |
125808262 | 12580826 | Ear haemorrhage | |
125808262 | 12580826 | Fatigue | |
125808262 | 12580826 | Fluid overload | |
125808262 | 12580826 | Fluid retention | |
125808262 | 12580826 | Flushing | |
125808262 | 12580826 | Gait disturbance | |
125808262 | 12580826 | Gastric ulcer | |
125808262 | 12580826 | Headache | |
125808262 | 12580826 | Hypotension | |
125808262 | 12580826 | Influenza like illness | |
125808262 | 12580826 | Injection site pain | |
125808262 | 12580826 | Localised oedema | |
125808262 | 12580826 | Malaise | |
125808262 | 12580826 | Muscle spasms | |
125808262 | 12580826 | Nausea | |
125808262 | 12580826 | Oedema peripheral | |
125808262 | 12580826 | Otorrhoea | |
125808262 | 12580826 | Pain | |
125808262 | 12580826 | Pain in jaw | |
125808262 | 12580826 | Palpitations | |
125808262 | 12580826 | Pericardial effusion | |
125808262 | 12580826 | Pleural effusion | |
125808262 | 12580826 | Productive cough | |
125808262 | 12580826 | Pyrexia | |
125808262 | 12580826 | Staphylococcal bacteraemia | |
125808262 | 12580826 | Syncope | |
125808262 | 12580826 | Upper respiratory tract infection | |
125808262 | 12580826 | Urinary incontinence | |
125808262 | 12580826 | Vomiting |
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 |
---|---|---|---|---|---|---|
125808262 | 12580826 | 5 | 20160307 | 0 | ||
125808262 | 12580826 | 11 | 20151229 | 20160309 | 0 | |
125808262 | 12580826 | 12 | 20160307 | 0 | ||
125808262 | 12580826 | 15 | 20110208 | 0 | ||
125808262 | 12580826 | 16 | 20130404 | 0 | ||
125808262 | 12580826 | 21 | 20130404 | 0 | ||
125808262 | 12580826 | 25 | 20110208 | 0 | ||
125808262 | 12580826 | 27 | 201501 | 0 | ||
125808262 | 12580826 | 29 | 20140608 | 201602 | 0 |