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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127191901 | 12719190 | 1 | I | 20160706 | 20160907 | 20160907 | PER | US-JNJFOC-20160706616 | JANSSEN | 0.00 | A | M | Y | 86.18000 | KG | 20160907 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127191901 | 12719190 | 1 | SS | FENTANYL TRANSDERMAL SYSTEM | FENTANYL | 1 | Transdermal | N | UNKNOWN;1512415P1 | 0 | MATRIX PATCH | ||||||||
| 127191901 | 12719190 | 2 | PS | FENTANYL TRANSDERMAL SYSTEM | FENTANYL | 1 | Transdermal | N | UNKNOWN;1512415P1 | 19813 | MATRIX PATCH | ||||||||
| 127191901 | 12719190 | 3 | C | OXYCODONE | OXYCODONE | 1 | Oral | DOSE: 5/325 MG AS NEEDED UPTO 6 TIMES PER DAY | 0 | TABLET | |||||||||
| 127191901 | 12719190 | 4 | C | AMLODIPINE BESYLATE. | AMLODIPINE BESYLATE | 1 | Oral | 0 | 5 | MG | TABLET | ||||||||
| 127191901 | 12719190 | 5 | C | AMITRIPTYLINE HYDROCHLORIDE. | AMITRIPTYLINE HYDROCHLORIDE | 1 | Oral | 0 | 50 | MG | TABLET | ||||||||
| 127191901 | 12719190 | 6 | C | ASPIRIN. | ASPIRIN | 1 | Oral | 0 | 81 | MG | TABLET | ||||||||
| 127191901 | 12719190 | 7 | C | ROPINIROLE HCL | ROPINIROLE HYDROCHLORIDE | 1 | Oral | UPTO 4 TIMES PER DAY | 0 | .5 | MG | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127191901 | 12719190 | 1 | Pain |
| 127191901 | 12719190 | 2 | Pain |
| 127191901 | 12719190 | 3 | Breakthrough pain |
| 127191901 | 12719190 | 4 | Blood pressure measurement |
| 127191901 | 12719190 | 5 | Depression |
| 127191901 | 12719190 | 6 | Hypertension |
| 127191901 | 12719190 | 7 | Restless legs syndrome |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127191901 | 12719190 | Affect lability | |
| 127191901 | 12719190 | Pain | |
| 127191901 | 12719190 | Product adhesion issue | |
| 127191901 | 12719190 | Restless legs syndrome | |
| 127191901 | 12719190 | Therapeutic response decreased |
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 |
|---|---|---|---|---|---|---|
| 127191901 | 12719190 | 1 | 201606 | 0 | ||
| 127191901 | 12719190 | 2 | 2016 | 201606 | 0 | |
| 127191901 | 12719190 | 3 | 201509 | 0 | ||
| 127191901 | 12719190 | 4 | 1986 | 0 | ||
| 127191901 | 12719190 | 5 | 1996 | 0 | ||
| 127191901 | 12719190 | 6 | 1986 | 0 |