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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125373871 | 12537387 | 1 | I | 20160623 | 20160707 | 20160707 | EXP | NL-JNJFOC-20160701917 | JANSSEN | AALST JV, TEERNSTRA O, WEBER W, RIJKERS K. AN UNUSUAL CASE OF POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME IN A PATIENT BEING WEANED FROM INTRATHECAL MORPHINE. INTERNATIONAL MEDICAL CASE REP JOURNAL 2016;9:117-120. | 63.00 | YR | A | F | Y | 0.00000 | 20160707 | MD | NL | NL |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125373871 | 12537387 | 1 | PS | DUROGESIC | FENTANYL | 1 | Transdermal | Y | N | 19813 | UNSPECIFIED | ||||||||
| 125373871 | 12537387 | 2 | SS | CLINDAMYCIN | CLINDAMYCINCLINDAMYCIN PHOSPHATE | 1 | Unknown | Y | 0 | 300 | MG | UNSPECIFIED | QID | ||||||
| 125373871 | 12537387 | 3 | SS | MORPHINE | MORPHINE | 1 | Intrathecal | Y | 0 | 3.5 | MG | UNSPECIFIED | |||||||
| 125373871 | 12537387 | 4 | SS | MORPHINE | MORPHINE | 1 | Intrathecal | Y | 0 | .5 | MG | UNSPECIFIED | |||||||
| 125373871 | 12537387 | 5 | SS | AMOXICILLIN+CLAVULANIC ACID | AMOXICILLINCLAVULANIC ACID | 1 | Unknown | Y | 0 | UNSPECIFIED | |||||||||
| 125373871 | 12537387 | 6 | SS | CLONIDINE. | CLONIDINE | 1 | Oral | Y | 0 | .15 | MG | UNSPECIFIED | TID | ||||||
| 125373871 | 12537387 | 7 | SS | AMITRIPTYLINE | AMITRIPTYLINE | 1 | Unknown | Y | 0 | 25 | MG | UNSPECIFIED | QD | ||||||
| 125373871 | 12537387 | 8 | SS | AMITRIPTYLINE | AMITRIPTYLINE | 1 | Unknown | Y | 0 | 10 | MG | UNSPECIFIED | |||||||
| 125373871 | 12537387 | 9 | SS | DIAZEPAM. | DIAZEPAM | 1 | Oral | Y | 0 | 5 | MG | UNSPECIFIED | TID | ||||||
| 125373871 | 12537387 | 10 | SS | AMOXICILLIN+CLAVULANIC ACID | AMOXICILLINCLAVULANIC ACID | 1 | Intravenous (not otherwise specified) | Y | 0 | UNSPECIFIED | |||||||||
| 125373871 | 12537387 | 11 | SS | OXYCODONE | OXYCODONE | 1 | Oral | Y | 0 | 20 | MG | UNSPECIFIED | QID | ||||||
| 125373871 | 12537387 | 12 | C | PROPOFOL. | PROPOFOL | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125373871 | 12537387 | 13 | C | ROCURONIUM | ROCURONIUM BROMIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125373871 | 12537387 | 14 | C | SEVOFLURANE. | SEVOFLURANE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 125373871 | 12537387 | 15 | C | SUFENTANIL CITRATE. | SUFENTANIL CITRATE | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125373871 | 12537387 | 1 | Pain |
| 125373871 | 12537387 | 2 | Product used for unknown indication |
| 125373871 | 12537387 | 3 | Amputation stump pain |
| 125373871 | 12537387 | 4 | Amputation stump pain |
| 125373871 | 12537387 | 5 | Product used for unknown indication |
| 125373871 | 12537387 | 6 | Pain |
| 125373871 | 12537387 | 7 | Amputation stump pain |
| 125373871 | 12537387 | 8 | Amputation stump pain |
| 125373871 | 12537387 | 9 | Muscle spasms |
| 125373871 | 12537387 | 10 | Local anaesthesia |
| 125373871 | 12537387 | 11 | Pain |
| 125373871 | 12537387 | 12 | General anaesthesia |
| 125373871 | 12537387 | 13 | General anaesthesia |
| 125373871 | 12537387 | 14 | General anaesthesia |
| 125373871 | 12537387 | 15 | General anaesthesia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125373871 | 12537387 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125373871 | 12537387 | Hemiparesis | |
| 125373871 | 12537387 | Posterior reversible encephalopathy syndrome |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |