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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125502251 | 12550225 | 1 | I | 20160630 | 20160712 | 20160712 | EXP | NL-APOTEX-2016AP009664 | APOTEX | 63.00 | YR | F | Y | 0.00000 | 20160712 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125502251 | 12550225 | 1 | PS | AMOXICILLIN, CLAVULANATE | AMOXICILLINCLAVULANATE POTASSIUM | 1 | Unknown | UNK UNK, UNKNOWN | Y | 65333 | QID | ||||||||
| 125502251 | 12550225 | 2 | SS | AMOXICILLIN, CLAVULANATE | AMOXICILLINCLAVULANATE POTASSIUM | 1 | Intravenous (not otherwise specified) | 1,000/200 MG FOUR TIMES A DAY | Y | 65333 | QID | ||||||||
| 125502251 | 12550225 | 3 | SS | DIAZEPAM APOTEX, TABLETTEN | DIAZEPAM | 1 | Oral | 5 MG, TID | Y | 0 | 5 | MG | TABLET | TID | |||||
| 125502251 | 12550225 | 4 | SS | AMITRIPTYLINE HCL APOTEX TABLETTEN | AMITRIPTYLINE | 1 | Unknown | 25 MG, QD | Y | 0 | 25 | MG | TABLET | ||||||
| 125502251 | 12550225 | 5 | SS | AMITRIPTYLINE HCL APOTEX TABLETTEN | AMITRIPTYLINE | 1 | Unknown | 10 MG, QD | Y | 0 | 10 | MG | TABLET | ||||||
| 125502251 | 12550225 | 6 | SS | MORPHINE | MORPHINE | 1 | Intrathecal | 3.5 MG, PER DAY | 0 | 3.5 | MG | ||||||||
| 125502251 | 12550225 | 7 | SS | MORPHINE | MORPHINE | 1 | Intrathecal | 0.5 MG, QD | 0 | .5 | MG | ||||||||
| 125502251 | 12550225 | 8 | SS | MORPHINE | MORPHINE | 1 | Intrathecal | 0.5 MG, QD ON THE FIFTH DAY | 0 | .5 | MG | ||||||||
| 125502251 | 12550225 | 9 | SS | CLINDAMYCIN | CLINDAMYCINCLINDAMYCIN PHOSPHATE | 1 | Unknown | 300 MG, QID | Y | 0 | 300 | MG | QID | ||||||
| 125502251 | 12550225 | 10 | SS | CLONIDINE. | CLONIDINE | 1 | Oral | 0.15 MG, TID | Y | 0 | .15 | MG | TID | ||||||
| 125502251 | 12550225 | 11 | SS | OXYCONTIN | OXYCODONE HYDROCHLORIDE | 1 | Oral | 20 MG, QID | Y | 0 | 20 | MG | QID | ||||||
| 125502251 | 12550225 | 12 | SS | DUROGESIC | FENTANYL | 1 | Transdermal | 100 ?G, Q.H. | Y | 0 | 100 | UG | /hr | ||||||
| 125502251 | 12550225 | 13 | SS | SEVOFLURANE. | SEVOFLURANE | 1 | Unknown | UNK, UNKNOWN | 0 | ||||||||||
| 125502251 | 12550225 | 14 | SS | PROPOFOL. | PROPOFOL | 1 | Unknown | UNK, UNKNOWN | 0 | ||||||||||
| 125502251 | 12550225 | 15 | SS | SUFENTANIL | SUFENTANIL | 1 | Unknown | UNK, UNKNOWN | 0 | ||||||||||
| 125502251 | 12550225 | 16 | SS | ROCURONIUM | ROCURONIUM BROMIDE | 1 | Unknown | UNK, UNKNOWN | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125502251 | 12550225 | 1 | Product used for unknown indication |
| 125502251 | 12550225 | 3 | Muscle spasms |
| 125502251 | 12550225 | 4 | Amputation stump pain |
| 125502251 | 12550225 | 6 | Amputation stump pain |
| 125502251 | 12550225 | 9 | Product used for unknown indication |
| 125502251 | 12550225 | 10 | Analgesic therapy |
| 125502251 | 12550225 | 11 | Analgesic therapy |
| 125502251 | 12550225 | 12 | Analgesic therapy |
| 125502251 | 12550225 | 13 | General anaesthesia |
| 125502251 | 12550225 | 14 | General anaesthesia |
| 125502251 | 12550225 | 15 | General anaesthesia |
| 125502251 | 12550225 | 16 | General anaesthesia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125502251 | 12550225 | OT |
| 125502251 | 12550225 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125502251 | 12550225 | Hemiparesis | |
| 125502251 | 12550225 | Implant site infection | |
| 125502251 | 12550225 | Infusion site extravasation | |
| 125502251 | 12550225 | Off label use | |
| 125502251 | 12550225 | 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 |