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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125498872 | 12549887 | 2 | F | 2005 | 20160713 | 20160712 | 20160728 | EXP | US-SAOL THERAPEUTICS-2016SAO00117 | SAOL THERAPEUTICS | 31.70 | YR | F | Y | 58.96000 | KG | 20160728 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125498872 | 12549887 | 1 | PS | LIORESAL | BACLOFEN | 1 | UNK | Y | 20075 | INJECTION | |||||||||
| 125498872 | 12549887 | 2 | SS | LIORESAL | BACLOFEN | 1 | Intrathecal | 713 ?G, DAY | Y | 20075 | 713 | UG | INJECTION | QD | |||||
| 125498872 | 12549887 | 3 | SS | LIORESAL | BACLOFEN | 1 | 650 ?G, DAY | Y | 20075 | 650 | UG | INJECTION | QD | ||||||
| 125498872 | 12549887 | 4 | SS | LIORESAL | BACLOFEN | 1 | 570 ?G, DAY | Y | 20075 | 570 | UG | INJECTION | QD | ||||||
| 125498872 | 12549887 | 5 | SS | LIORESAL | BACLOFEN | 1 | 500 ?G, DAY | Y | 20075 | 500 | UG | INJECTION | QD | ||||||
| 125498872 | 12549887 | 6 | SS | LIORESAL | BACLOFEN | 1 | 400 ?G, DAY | Y | 20075 | 400 | UG | INJECTION | QD | ||||||
| 125498872 | 12549887 | 7 | SS | LIORESAL | BACLOFEN | 1 | 320 ?G, DAY | Y | 20075 | 320 | UG | INJECTION | QD | ||||||
| 125498872 | 12549887 | 8 | SS | LIORESAL | BACLOFEN | 1 | 280 ?G, DAY | Y | 20075 | 280 | UG | INJECTION | QD | ||||||
| 125498872 | 12549887 | 9 | SS | LIORESAL | BACLOFEN | 1 | 240 ?G, DAY | Y | 20075 | 240 | UG | INJECTION | QD | ||||||
| 125498872 | 12549887 | 10 | C | KEPPRA | LEVETIRACETAM | 1 | 15 ML, 2X/DAY | 0 | 15 | ML | BID | ||||||||
| 125498872 | 12549887 | 11 | C | ZANTAC | RANITIDINE HYDROCHLORIDE | 1 | 10 ML, 2X/DAY | 0 | 10 | ML | BID | ||||||||
| 125498872 | 12549887 | 12 | C | CREON | PANCRELIPASE AMYLASEPANCRELIPASE LIPASEPANCRELIPASE PROTEASE | 1 | 1 UNKNOWN, 4X/DAY | 0 | QID | ||||||||||
| 125498872 | 12549887 | 13 | C | VITAMIN D | CHOLECALCIFEROL | 1 | 2000 UNK, DAY | 0 | QD | ||||||||||
| 125498872 | 12549887 | 14 | C | MELATONIN | MELATONIN | 1 | 3 MG, 1X/DAY | 0 | 3 | MG | QD | ||||||||
| 125498872 | 12549887 | 15 | C | VALIUM | DIAZEPAM | 1 | 5 MG, AS NEEDED | 0 | 5 | MG | |||||||||
| 125498872 | 12549887 | 16 | C | MIRALAX | POLYETHYLENE GLYCOL 3350 | 1 | UNK UNK, AS NEEDED | 0 | |||||||||||
| 125498872 | 12549887 | 17 | C | MOTRIN | IBUPROFEN | 1 | UNK, AS NEEDED | 0 | |||||||||||
| 125498872 | 12549887 | 18 | SS | AVELOX | MOXIFLOXACIN HYDROCHLORIDE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125498872 | 12549887 | 1 | Muscle spasticity |
| 125498872 | 12549887 | 2 | Cerebral palsy |
| 125498872 | 12549887 | 6 | Muscle spasticity |
| 125498872 | 12549887 | 7 | Cerebral palsy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125498872 | 12549887 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125498872 | 12549887 | Adenotonsillectomy | |
| 125498872 | 12549887 | Complication associated with device | |
| 125498872 | 12549887 | Drug withdrawal syndrome | |
| 125498872 | 12549887 | Femur fracture | |
| 125498872 | 12549887 | Hypertonia | |
| 125498872 | 12549887 | Tongue injury | |
| 125498872 | 12549887 | Tracheostomy | |
| 125498872 | 12549887 | Tremor | |
| 125498872 | 12549887 | Wisdom teeth removal |
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 |
|---|---|---|---|---|---|---|
| 125498872 | 12549887 | 1 | 1998 | 0 | ||
| 125498872 | 12549887 | 4 | 20160428 | 0 | ||
| 125498872 | 12549887 | 5 | 20160521 | 0 | ||
| 125498872 | 12549887 | 6 | 201606 | 0 | ||
| 125498872 | 12549887 | 7 | 201606 | 0 | ||
| 125498872 | 12549887 | 8 | 20160621 | 0 | ||
| 125498872 | 12549887 | 9 | 20160701 | 0 | ||
| 125498872 | 12549887 | 10 | 2010 | 0 |