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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125559791 | 12555979 | 1 | I | 20160630 | 20160714 | 20160714 | EXP | NL-AUROBINDO-AUR-APL-2016-09015 | AUROBINDO | 63.00 | YR | F | Y | 0.00000 | 20160714 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125559791 | 12555979 | 1 | PS | Amoxicillin+Clavulanic acid 500/125mg | AMOXICILLINCLAVULANIC ACID | 1 | Unknown | UNK | U | 91568 | |||||||||
| 125559791 | 12555979 | 2 | SS | CLINDAMYCIN | CLINDAMYCINCLINDAMYCIN PHOSPHATE | 1 | Unknown | 300 MG, FOUR TIMES/DAY | Y | U | 0 | 300 | MG | QID | |||||
| 125559791 | 12555979 | 3 | SS | MORPHINE | MORPHINE | 1 | Intrathecal | 3.5 MG, UNK | Y | U | 0 | 3.5 | MG | ||||||
| 125559791 | 12555979 | 4 | SS | MORPHINE | MORPHINE | 1 | Intrathecal | Y | U | 0 | .5 | MG | |||||||
| 125559791 | 12555979 | 5 | SS | AMOXICILLIN+CLAVULANIC ACID | AMOXICILLINCLAVULANIC ACID | 1 | Intravenous (not otherwise specified) | UNK | Y | U | 0 | ||||||||
| 125559791 | 12555979 | 6 | SS | CLONIDINE. | CLONIDINE | 1 | Oral | 0.15 MG, 3 TIMES A DAY | Y | U | 0 | .15 | MG | TID | |||||
| 125559791 | 12555979 | 7 | SS | OXYCONTIN | OXYCODONE HYDROCHLORIDE | 1 | Oral | 20 MG, FOUR TIMES/DAY | Y | U | 0 | 20 | MG | QID | |||||
| 125559791 | 12555979 | 8 | SS | DUROGESIC | FENTANYL | 1 | Transdermal | 100 ?G, UNK | Y | U | 0 | 100 | UG | ||||||
| 125559791 | 12555979 | 9 | SS | DIAZEPAM. | DIAZEPAM | 1 | Oral | 5 MG, 3 TIMES A DAY | Y | U | 0 | 5 | MG | TID | |||||
| 125559791 | 12555979 | 10 | C | SEVOFLURANE. | SEVOFLURANE | 1 | Unknown | UNK | Y | U | 0 | ||||||||
| 125559791 | 12555979 | 11 | C | PROPOFOL. | PROPOFOL | 1 | Y | U | 0 | ||||||||||
| 125559791 | 12555979 | 12 | C | SUFENTANIL | SUFENTANIL | 1 | Y | U | 0 | ||||||||||
| 125559791 | 12555979 | 13 | C | ROCURONIUM | ROCURONIUM BROMIDE | 1 | Y | U | 0 | ||||||||||
| 125559791 | 12555979 | 14 | SS | AMITRIPTYLINE | AMITRIPTYLINE | 1 | Unknown | 25 MG, ONCE A DAY | Y | U | 0 | 25 | MG | QD | |||||
| 125559791 | 12555979 | 15 | SS | AMITRIPTYLINE | AMITRIPTYLINE | 1 | Y | U | 0 | 10 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125559791 | 12555979 | 1 | Product used for unknown indication |
| 125559791 | 12555979 | 2 | Product used for unknown indication |
| 125559791 | 12555979 | 3 | Amputation stump pain |
| 125559791 | 12555979 | 5 | Product used for unknown indication |
| 125559791 | 12555979 | 6 | Pain |
| 125559791 | 12555979 | 7 | Pain |
| 125559791 | 12555979 | 8 | Pain |
| 125559791 | 12555979 | 9 | Muscle spasms |
| 125559791 | 12555979 | 10 | General anaesthesia |
| 125559791 | 12555979 | 11 | General anaesthesia |
| 125559791 | 12555979 | 12 | General anaesthesia |
| 125559791 | 12555979 | 13 | General anaesthesia |
| 125559791 | 12555979 | 14 | Amputation stump pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125559791 | 12555979 | OT |
| 125559791 | 12555979 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125559791 | 12555979 | Drug withdrawal syndrome | |
| 125559791 | 12555979 | Hemiparesis | |
| 125559791 | 12555979 | 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 |