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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126201743 | 12620174 | 3 | F | 201311 | 20160907 | 20160803 | 20160922 | EXP | US-SAOL THERAPEUTICS-2016SAO00281 | SAOL THERAPEUTICS | 43.54 | YR | F | Y | 63.95000 | KG | 20160922 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126201743 | 12620174 | 1 | PS | BACLOFEN. | BACLOFEN | 1 | 0.64 MG, DAY | U | U | 20075 | .64 | MG | INJECTION | QD | |||||
| 126201743 | 12620174 | 2 | SS | BACLOFEN. | BACLOFEN | 1 | 0.6559 ?G, DAY | U | U | 20075 | .655 | UG | INJECTION | QD | |||||
| 126201743 | 12620174 | 3 | SS | FENTANYL. | FENTANYL | 1 | 8.0 MG, DAY | 0 | 8 | MG | QD | ||||||||
| 126201743 | 12620174 | 4 | SS | FENTANYL. | FENTANYL | 1 | 8.199 UNK, UNK | 0 | 8.199 | MG | QD | ||||||||
| 126201743 | 12620174 | 5 | SS | CLONIDINE. | CLONIDINE | 1 | Intrathecal | 0.064 MG, DAY | U | 0 | .064 | MG | QD | ||||||
| 126201743 | 12620174 | 6 | SS | CLONIDINE. | CLONIDINE | 1 | 0.065 MG, DAY | U | 0 | .065 | MG | QD | |||||||
| 126201743 | 12620174 | 7 | SS | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | Intrathecal | 2.912 MG, DAY | U | 0 | 2.912 | MG | QD | ||||||
| 126201743 | 12620174 | 8 | SS | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | 2.984 MG, DAY | U | 0 | 2.984 | MG | QD | |||||||
| 126201743 | 12620174 | 9 | SS | BACLOFEN COMPOUNDED | BACLOFEN | 1 | Intrathecal | 0.5758 MG/DAY | U | 0 | INJECTION | ||||||||
| 126201743 | 12620174 | 10 | SS | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | 0 | ||||||||||||
| 126201743 | 12620174 | 11 | SS | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 126201743 | 12620174 | 12 | SS | DIAZEPAM. | DIAZEPAM | 1 | 0 | ||||||||||||
| 126201743 | 12620174 | 13 | SS | IMITREX | SUMATRIPTAN SUCCINATE | 1 | 0 | ||||||||||||
| 126201743 | 12620174 | 14 | SS | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 126201743 | 12620174 | 15 | SS | ESTRADIOL. | ESTRADIOL | 1 | 0 | ||||||||||||
| 126201743 | 12620174 | 16 | SS | TOPAMAX | TOPIRAMATE | 1 | 0 | ||||||||||||
| 126201743 | 12620174 | 17 | C | DILANTIN | PHENYTOIN | 1 | 0 | ||||||||||||
| 126201743 | 12620174 | 18 | C | VIMPAT | LACOSAMIDE | 1 | 0 | ||||||||||||
| 126201743 | 12620174 | 19 | C | MIRTAZAPINE. | MIRTAZAPINE | 1 | 0 | ||||||||||||
| 126201743 | 12620174 | 20 | C | LAMICTAL | LAMOTRIGINE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126201743 | 12620174 | 1 | Post laminectomy syndrome |
| 126201743 | 12620174 | 2 | Pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126201743 | 12620174 | HO |
| 126201743 | 12620174 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126201743 | 12620174 | Abdominal discomfort | |
| 126201743 | 12620174 | Device malfunction | |
| 126201743 | 12620174 | Diarrhoea | |
| 126201743 | 12620174 | Drug administration error | |
| 126201743 | 12620174 | Drug withdrawal syndrome | |
| 126201743 | 12620174 | Feeling of body temperature change | |
| 126201743 | 12620174 | Infusion site mass | |
| 126201743 | 12620174 | Medical device discomfort | |
| 126201743 | 12620174 | Memory impairment | |
| 126201743 | 12620174 | Nausea | |
| 126201743 | 12620174 | Oedema | |
| 126201743 | 12620174 | Off label use | |
| 126201743 | 12620174 | Pain | |
| 126201743 | 12620174 | Seizure | |
| 126201743 | 12620174 | Swelling | |
| 126201743 | 12620174 | Tinnitus |
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 |
|---|---|---|---|---|---|---|
| 126201743 | 12620174 | 1 | 20131118 | 0 | ||
| 126201743 | 12620174 | 2 | 20131118 | 0 | ||
| 126201743 | 12620174 | 3 | 20131118 | 0 | ||
| 126201743 | 12620174 | 4 | 20131118 | 0 | ||
| 126201743 | 12620174 | 5 | 20131118 | 0 | ||
| 126201743 | 12620174 | 6 | 20131118 | 0 | ||
| 126201743 | 12620174 | 7 | 20131118 | 0 | ||
| 126201743 | 12620174 | 8 | 20131118 | 0 |