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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126491142 | 12649114 | 2 | F | 2014 | 20160824 | 20160812 | 20160908 | EXP | US-SAOL THERAPEUTICS-2016SAO00367 | SAOL THERAPEUTICS | 47.07 | YR | F | Y | 0.00000 | 20160908 | CN | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126491142 | 12649114 | 1 | PS | BACLOFEN. | BACLOFEN | 1 | Intrathecal | 70 ?G, DAY | U | U | 20075 | 70 | UG | INJECTION | QD | ||||
| 126491142 | 12649114 | 2 | SS | BACLOFEN. | BACLOFEN | 1 | UNK MG, UNK | 0 | |||||||||||
| 126491142 | 12649114 | 3 | SS | COMPOUNDED BACLOFEN | BACLOFEN | 1 | 70 ?G, DAY | 0 | 70 | UG | INJECTION | QD | |||||||
| 126491142 | 12649114 | 4 | SS | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | Intrathecal | 3.78 MG, DAY | U | 0 | 3.78 | MG | QD | ||||||
| 126491142 | 12649114 | 5 | SS | FENTANYL. | FENTANYL | 1 | Intrathecal | 630 ?G, DAY | U | 0 | 630 | UG | QD | ||||||
| 126491142 | 12649114 | 6 | SS | BUPIVACAINE. | BUPIVACAINE | 1 | Intrathecal | 7.6 MG, DAY | U | 0 | 7.6 | MG | QD | ||||||
| 126491142 | 12649114 | 7 | SS | TIZANIDINE. | TIZANIDINE | 1 | UNK | 0 | |||||||||||
| 126491142 | 12649114 | 8 | SS | REMERON | MIRTAZAPINE | 1 | UNK | 0 | |||||||||||
| 126491142 | 12649114 | 9 | SS | TOPAMAX | TOPIRAMATE | 1 | 0 | ||||||||||||
| 126491142 | 12649114 | 10 | SS | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | 0 | ||||||||||||
| 126491142 | 12649114 | 11 | SS | MIDRIN | ACETAMINOPHENDICHLORALPHENAZONEISOMETHEPTENE | 1 | 0 | ||||||||||||
| 126491142 | 12649114 | 12 | SS | LEXAPRO | ESCITALOPRAM OXALATE | 1 | 0 | ||||||||||||
| 126491142 | 12649114 | 13 | SS | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | 0 | ||||||||||||
| 126491142 | 12649114 | 14 | C | DIAZEPAM. | DIAZEPAM | 1 | Oral | 20 MG, DAY | 0 | 20 | MG | QD | |||||||
| 126491142 | 12649114 | 15 | C | PERCOCET | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | Oral | 40 MG, DAY | 0 | 40 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126491142 | 12649114 | 1 | Pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126491142 | 12649114 | OT |
| 126491142 | 12649114 | HO |
| 126491142 | 12649114 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126491142 | 12649114 | Alopecia | |
| 126491142 | 12649114 | Bedridden | |
| 126491142 | 12649114 | Cardiac disorder | |
| 126491142 | 12649114 | Catheter site swelling | |
| 126491142 | 12649114 | Chest discomfort | |
| 126491142 | 12649114 | Chest pain | |
| 126491142 | 12649114 | Chills | |
| 126491142 | 12649114 | Cognitive disorder | |
| 126491142 | 12649114 | Disturbance in attention | |
| 126491142 | 12649114 | Drug withdrawal syndrome | |
| 126491142 | 12649114 | Dry skin | |
| 126491142 | 12649114 | Dyspnoea | |
| 126491142 | 12649114 | Fall | |
| 126491142 | 12649114 | Fatigue | |
| 126491142 | 12649114 | General physical condition abnormal | |
| 126491142 | 12649114 | Headache | |
| 126491142 | 12649114 | Heart rate increased | |
| 126491142 | 12649114 | Hyperhidrosis | |
| 126491142 | 12649114 | Influenza | |
| 126491142 | 12649114 | Loss of consciousness | |
| 126491142 | 12649114 | Malaise | |
| 126491142 | 12649114 | Muscle spasms | |
| 126491142 | 12649114 | Muscle spasticity | |
| 126491142 | 12649114 | Muscular weakness | |
| 126491142 | 12649114 | Nasopharyngitis | |
| 126491142 | 12649114 | Nightmare | |
| 126491142 | 12649114 | Off label use | |
| 126491142 | 12649114 | Overdose | |
| 126491142 | 12649114 | Pain | |
| 126491142 | 12649114 | Paraesthesia | |
| 126491142 | 12649114 | Performance status decreased | |
| 126491142 | 12649114 | Post lumbar puncture syndrome | |
| 126491142 | 12649114 | Pruritus | |
| 126491142 | 12649114 | Road traffic accident | |
| 126491142 | 12649114 | Toxicity to various agents | |
| 126491142 | 12649114 | Tremor | |
| 126491142 | 12649114 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 126491142 | 12649114 | 3 | 20150603 | 0 | ||
| 126491142 | 12649114 | 4 | 20150603 | 0 | ||
| 126491142 | 12649114 | 5 | 20150603 | 0 | ||
| 126491142 | 12649114 | 6 | 20150603 | 0 |