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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125357681 | 12535768 | 1 | I | 20160623 | 20160707 | 20160707 | EXP | NL-ALVOGEN-2016-ALVOGEN-025540 | ALVOGEN | VAN AALST J, TEERNSTRA OP, WEBER WE, RIJKERS K. AN UNUSUAL CASE OF POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME IN A PATIENT BEING WEANED FROM INTRATHECAL MORPHINE. INTERNATIONAL MEDICAL CASE REPORTS JOURNAL. 2016;9 : 117-120. | 63.00 | YR | F | Y | 0.00000 | 20160707 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125357681 | 12535768 | 1 | PS | CLINDAMYCIN | CLINDAMYCINCLINDAMYCIN PHOSPHATE | 1 | Y | 62800 | 300 | MG | QID | ||||||||
| 125357681 | 12535768 | 2 | SS | MORPHINE | MORPHINE | 1 | Intrathecal | EQUIVALENT OF 1,000 MG ORALLY | Y | 0 | 3.5 | MG | |||||||
| 125357681 | 12535768 | 3 | SS | AUGMENTIN | AMOXICILLINCLAVULANATE POTASSIUM | 1 | 500/125 MG | Y | 0 | MG | QID | ||||||||
| 125357681 | 12535768 | 4 | SS | CLONIDINE HYDROCHLORIDE. | CLONIDINE HYDROCHLORIDE | 1 | Oral | Y | 0 | .15 | MG | QD | |||||||
| 125357681 | 12535768 | 5 | SS | OXYCONTIN | OXYCODONE HYDROCHLORIDE | 1 | Oral | Y | 0 | 20 | MG | QID | |||||||
| 125357681 | 12535768 | 6 | SS | DUROGESIC | FENTANYL | 1 | TRANSCUTANEOUSLY | Y | 0 | 100 | UG | /hr | |||||||
| 125357681 | 12535768 | 7 | SS | DIAZEPAM. | DIAZEPAM | 1 | Oral | Y | 0 | 5 | MG | QID | |||||||
| 125357681 | 12535768 | 8 | SS | AMITRIPTYLINE | AMITRIPTYLINE | 1 | Y | 0 | 25 | MG | QD | ||||||||
| 125357681 | 12535768 | 9 | C | SEVOFLURANE. | SEVOFLURANE | 1 | 0 | ||||||||||||
| 125357681 | 12535768 | 10 | C | PROPOFOL. | PROPOFOL | 1 | 0 | ||||||||||||
| 125357681 | 12535768 | 11 | C | SUFENTANIL | SUFENTANIL | 1 | 0 | ||||||||||||
| 125357681 | 12535768 | 12 | C | ROCURONIUM | ROCURONIUM BROMIDE | 1 | 0 | ||||||||||||
| 125357681 | 12535768 | 13 | SS | AMITRIPTYLINE | AMITRIPTYLINE | 1 | 0 | 10 | MG | QD | |||||||||
| 125357681 | 12535768 | 14 | SS | MORPHINE | MORPHINE | 1 | Intrathecal | EQUIVALENT OF 1,000 MG ORALLY | Y | 0 | .5 | MG | |||||||
| 125357681 | 12535768 | 15 | SS | AUGMENTIN | AMOXICILLINCLAVULANATE POTASSIUM | 1 | 1000/200 MG | Y | 0 | MG | QID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125357681 | 12535768 | 1 | Product used for unknown indication |
| 125357681 | 12535768 | 2 | Amputation stump pain |
| 125357681 | 12535768 | 3 | Product used for unknown indication |
| 125357681 | 12535768 | 4 | Pain |
| 125357681 | 12535768 | 5 | Pain |
| 125357681 | 12535768 | 6 | Pain |
| 125357681 | 12535768 | 7 | Muscle spasms |
| 125357681 | 12535768 | 8 | Amputation stump pain |
| 125357681 | 12535768 | 9 | General anaesthesia |
| 125357681 | 12535768 | 10 | General anaesthesia |
| 125357681 | 12535768 | 11 | General anaesthesia |
| 125357681 | 12535768 | 12 | General anaesthesia |
| 125357681 | 12535768 | 13 | Pain |
| 125357681 | 12535768 | 14 | Amputation stump pain |
| 125357681 | 12535768 | 15 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125357681 | 12535768 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125357681 | 12535768 | Hemiparesis | |
| 125357681 | 12535768 | Posterior reversible encephalopathy syndrome | |
| 125357681 | 12535768 | Self-medication |
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 |
|---|---|---|---|---|---|---|
| 125357681 | 12535768 | 2 | 1999 | 0 | ||
| 125357681 | 12535768 | 14 | 1999 | 0 |