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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126564902 | 12656490 | 2 | F | 201402 | 20160801 | 20160816 | 20160817 | EXP | US-SAOL THERAPEUTICS-2016SAO00415 | SAOL THERAPEUTICS | 17.02 | YR | F | Y | 0.00000 | 20160816 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126564902 | 12656490 | 1 | PS | LIORESAL | BACLOFEN | 1 | Intrathecal | 727 ?G, DAY | U | U | 20075 | 727 | UG | INJECTION | QD | ||||
| 126564902 | 12656490 | 2 | SS | LIORESAL | BACLOFEN | 1 | U | U | 20075 | INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126564902 | 12656490 | 1 | Cerebral palsy |
| 126564902 | 12656490 | 2 | Muscle spasticity |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126564902 | 12656490 | DE |
| 126564902 | 12656490 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126564902 | 12656490 | Agitation | |
| 126564902 | 12656490 | Altered state of consciousness | |
| 126564902 | 12656490 | Anxiety | |
| 126564902 | 12656490 | Appetite disorder | |
| 126564902 | 12656490 | Bruxism | |
| 126564902 | 12656490 | Crying | |
| 126564902 | 12656490 | Device connection issue | |
| 126564902 | 12656490 | Device damage | |
| 126564902 | 12656490 | Device malfunction | |
| 126564902 | 12656490 | Device occlusion | |
| 126564902 | 12656490 | Discomfort | |
| 126564902 | 12656490 | Drug withdrawal syndrome | |
| 126564902 | 12656490 | Dyspnoea | |
| 126564902 | 12656490 | Emotional distress | |
| 126564902 | 12656490 | Gastrointestinal haemorrhage | |
| 126564902 | 12656490 | Gastrointestinal necrosis | |
| 126564902 | 12656490 | Infectious mononucleosis | |
| 126564902 | 12656490 | Injury | |
| 126564902 | 12656490 | Intestinal ischaemia | |
| 126564902 | 12656490 | Lethargy | |
| 126564902 | 12656490 | Mobility decreased | |
| 126564902 | 12656490 | Muscle rigidity | |
| 126564902 | 12656490 | Muscle spasticity | |
| 126564902 | 12656490 | Muscle tightness | |
| 126564902 | 12656490 | Nausea | |
| 126564902 | 12656490 | Overdose | |
| 126564902 | 12656490 | Pain | |
| 126564902 | 12656490 | Pupillary disorder | |
| 126564902 | 12656490 | Retching | |
| 126564902 | 12656490 | Screaming | |
| 126564902 | 12656490 | Sedation | |
| 126564902 | 12656490 | Underdose | |
| 126564902 | 12656490 | Unevaluable event | |
| 126564902 | 12656490 | Unresponsive to stimuli | |
| 126564902 | 12656490 | Vomiting | |
| 126564902 | 12656490 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 126564902 | 12656490 | 1 | 20140730 | 0 |