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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123333214 | 12333321 | 4 | F | 201505 | 20160816 | 20160504 | 20160825 | EXP | US-JNJFOC-20160424310 | JANSSEN | 54.68 | YR | A | M | Y | 0.00000 | 20160825 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123333214 | 12333321 | 1 | PS | XARELTO | RIVAROXABAN | 1 | Oral | Y | N | UNKNOWN | 22406 | TABLET | |||||||
| 123333214 | 12333321 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | REGIMEN# 41.5 NG/KG/MIN CONTINUOUSLY | U052;U202;U202;V380;V380 +MORE | 0 | POWDER | ||||||||
| 123333214 | 12333321 | 3 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 50 NG/KG/MIN | U052;U202;U202;V380;V380 +MORE | 0 | 93 | ML | POWDER | ||||||
| 123333214 | 12333321 | 4 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 50 NG/KG/MIN (CONC 75,000 NG/ML, PUMP RATE 93 ML/DAY, VIAL STRENGTH 1.5), CO | U052;U202;U202;V380;V380 +MORE | 0 | POWDER | ||||||||
| 123333214 | 12333321 | 5 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | REGIMEN#6 50 NG/KG/MIN CONTINUOUS | U052;U202;U202;V380;V380 +MORE | 0 | POWDER | ||||||||
| 123333214 | 12333321 | 6 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 50 NG/KG/MIN (CONC 75,000 NG/ML, PUMP RATE 93 ML/DAY, VIAL STRENGTH 1.5), CONTINUOUS IV INFUSION | U052;U202;U202;V380;V380 +MORE | 0 | POWDER | ||||||||
| 123333214 | 12333321 | 7 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | REGIMEN#4 22 ML/KG/MIN CONTINUOUS INTRAVENOUS INFUSION | U052;U202;U202;V380;V380 +MORE | 0 | POWDER | ||||||||
| 123333214 | 12333321 | 8 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | REGIMEN 2: 75,000 NG/ML PUMP RATE 77 ML/DAY, VIAL STRENGTH 1.5 MG), CONTINUOUS, INTRAVENOUS INFUSION | U052;U202;U202;V380;V380 +MORE | 0 | POWDER | ||||||||
| 123333214 | 12333321 | 9 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 50 NG/KG/MIN | U052;U202;U202;V380;V380 +MORE | 0 | 93 | ML | POWDER | ||||||
| 123333214 | 12333321 | 10 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | REGIMEN 2: 75,000 NG/ML PUMP RATE 77 ML/DAY, VIAL STRENGTH 1.5 MG), CONTINUOUS, INTRAVENOUS INFUSION | U052;U202;U202;V380;V380 +MORE | 0 | POWDER | ||||||||
| 123333214 | 12333321 | 11 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | REGIMEN# 41.5 NG/KG/MIN CONTINUOUSLY | U052;U202;U202;V380;V380 +MORE | 0 | POWDER | ||||||||
| 123333214 | 12333321 | 12 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 50 NG/KG/MIN (CONC 75,000 NG/ML, PUMP RATE 93 ML/DAY, VIAL STRENGTH 1.5), CO | U052;U202;U202;V380;V380 +MORE | 0 | POWDER | ||||||||
| 123333214 | 12333321 | 13 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | REGIMEN#6 50 NG/KG/MIN CONTINUOUS | U052;U202;U202;V380;V380 +MORE | 0 | POWDER | ||||||||
| 123333214 | 12333321 | 14 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 50 NG/KG/MIN (CONC 75,000 NG/ML, PUMP RATE 93 ML/DAY, VIAL STRENGTH 1.5), CONTINUOUS IV INFUSION | U052;U202;U202;V380;V380 +MORE | 0 | POWDER | ||||||||
| 123333214 | 12333321 | 15 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | REGIMEN#4 22 ML/KG/MIN CONTINUOUS INTRAVENOUS INFUSION | U052;U202;U202;V380;V380 +MORE | 0 | POWDER | ||||||||
| 123333214 | 12333321 | 16 | SS | COUMADIN | WARFARIN SODIUM | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 123333214 | 12333321 | 17 | C | BOSENTAN. | BOSENTAN | 1 | Unknown | 0 | |||||||||||
| 123333214 | 12333321 | 18 | C | ADCIRCA | TADALAFIL | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123333214 | 12333321 | 1 | Product used for unknown indication |
| 123333214 | 12333321 | 2 | Pulmonary arterial hypertension |
| 123333214 | 12333321 | 3 | Pulmonary arterial hypertension |
| 123333214 | 12333321 | 4 | Pulmonary arterial hypertension |
| 123333214 | 12333321 | 5 | Pulmonary arterial hypertension |
| 123333214 | 12333321 | 6 | Pulmonary arterial hypertension |
| 123333214 | 12333321 | 7 | Pulmonary arterial hypertension |
| 123333214 | 12333321 | 8 | Pulmonary arterial hypertension |
| 123333214 | 12333321 | 9 | Pulmonary arterial hypertension |
| 123333214 | 12333321 | 10 | Pulmonary arterial hypertension |
| 123333214 | 12333321 | 11 | Pulmonary arterial hypertension |
| 123333214 | 12333321 | 12 | Pulmonary arterial hypertension |
| 123333214 | 12333321 | 13 | Pulmonary arterial hypertension |
| 123333214 | 12333321 | 14 | Pulmonary arterial hypertension |
| 123333214 | 12333321 | 15 | Pulmonary arterial hypertension |
| 123333214 | 12333321 | 16 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123333214 | 12333321 | HO |
| 123333214 | 12333321 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123333214 | 12333321 | Adverse drug reaction | |
| 123333214 | 12333321 | Catheter management | |
| 123333214 | 12333321 | Device related infection | |
| 123333214 | 12333321 | Gastrointestinal haemorrhage | |
| 123333214 | 12333321 | Headache | |
| 123333214 | 12333321 | Pain in extremity | |
| 123333214 | 12333321 | Pain in jaw | |
| 123333214 | 12333321 | Pancreatitis acute | |
| 123333214 | 12333321 | Portal hypertensive gastropathy | |
| 123333214 | 12333321 | Syncope | |
| 123333214 | 12333321 | Therapeutic procedure |
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 |
|---|---|---|---|---|---|---|
| 123333214 | 12333321 | 3 | 20070321 | 0 | ||
| 123333214 | 12333321 | 9 | 20070321 | 0 |