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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125421893 | 12542189 | 3 | F | 2016 | 20160801 | 20160708 | 20160816 | EXP | US-SAOL THERAPEUTICS-2016SAO00105 | SAOL THERAPEUTICS | 74.40 | YR | F | Y | 0.00000 | 20160816 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125421893 | 12542189 | 1 | PS | BACLOFEN. | BACLOFEN | 1 | Intrathecal | 61.95 ?G, DAY | U | U | UNK | 20075 | 61.95 | UG | INJECTION | QD | |||
| 125421893 | 12542189 | 2 | SS | BACLOFEN. | BACLOFEN | 1 | U | U | 20075 | INJECTION | |||||||||
| 125421893 | 12542189 | 3 | SS | BUPIVACAINE. | BUPIVACAINE | 1 | Intrathecal | 5.632 MG, DAY | U | 0 | 5.632 | MG | QD | ||||||
| 125421893 | 12542189 | 4 | SS | BUPIVACAINE. | BUPIVACAINE | 1 | U | 0 | |||||||||||
| 125421893 | 12542189 | 5 | SS | MORPHINE | MORPHINE | 1 | Intrathecal | 18.772 MG, DAY | U | 0 | 18.772 | MG | QD | ||||||
| 125421893 | 12542189 | 6 | SS | MORPHINE | MORPHINE | 1 | U | 0 | |||||||||||
| 125421893 | 12542189 | 7 | SS | MORPHINE | MORPHINE | 1 | Intrathecal | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125421893 | 12542189 | 1 | Pain |
| 125421893 | 12542189 | 2 | Back pain |
| 125421893 | 12542189 | 3 | Pain |
| 125421893 | 12542189 | 4 | Back pain |
| 125421893 | 12542189 | 5 | Pain |
| 125421893 | 12542189 | 6 | Back pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125421893 | 12542189 | HO |
| 125421893 | 12542189 | DS |
| 125421893 | 12542189 | OT |
| 125421893 | 12542189 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125421893 | 12542189 | Abnormal behaviour | |
| 125421893 | 12542189 | Amnesia | |
| 125421893 | 12542189 | Asthenia | |
| 125421893 | 12542189 | Diet refusal | |
| 125421893 | 12542189 | Drug ineffective for unapproved indication | |
| 125421893 | 12542189 | Endotracheal intubation | |
| 125421893 | 12542189 | Hospitalisation | |
| 125421893 | 12542189 | Incorrect route of drug administration | |
| 125421893 | 12542189 | Mania | |
| 125421893 | 12542189 | Mobility decreased | |
| 125421893 | 12542189 | Muscle spasms | |
| 125421893 | 12542189 | Pain | |
| 125421893 | 12542189 | Refusal of treatment by patient | |
| 125421893 | 12542189 | Suicidal ideation |
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 |
|---|---|---|---|---|---|---|
| 125421893 | 12542189 | 1 | 2015 | 0 |