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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125981111 | 12598111 | 1 | I | 20160429 | 20160620 | 20160726 | 20160726 | EXP | US-SAOL THERAPEUTICS-2016SAO00079 | SAOL THERAPEUTICS | 46.40 | YR | F | Y | 0.00000 | 20160726 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125981111 | 12598111 | 1 | PS | BACLOFEN. | BACLOFEN | 1 | Intrathecal | 184.55 ?G, DAY | U | U | 20075 | 184.55 | UG | INJECTION | QD | ||||
125981111 | 12598111 | 2 | SS | BACLOFEN. | BACLOFEN | 1 | Intrathecal | 231.26 ?G, DAY | U | U | 20075 | 231.26 | UG | INJECTION | QD | ||||
125981111 | 12598111 | 3 | SS | FENTANYL. | FENTANYL | 1 | Intrathecal | 4.614 MG, DAY | U | U | 0 | 4.614 | MG | QD | |||||
125981111 | 12598111 | 4 | SS | FENTANYL. | FENTANYL | 1 | Intrathecal | 5.781 MG, DAY | U | U | 0 | 5.781 | MG | QD | |||||
125981111 | 12598111 | 5 | C | AMYLTRIPTYLINE | 2 | 75 MG, UNK | 0 | 75 | MG | TABLET | |||||||||
125981111 | 12598111 | 6 | C | ATIVIAN | 2 | 0.5 MG, UNK | 0 | .5 | MG | TABLET | |||||||||
125981111 | 12598111 | 7 | C | CELEXA | CITALOPRAM HYDROBROMIDE | 1 | 40 MG, UNK | 0 | 40 | MG | TABLET | ||||||||
125981111 | 12598111 | 8 | C | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | 0 | ||||||||||||
125981111 | 12598111 | 9 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | 175 ?G, UNK | 0 | 175 | UG |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
125981111 | 12598111 | 1 | Pain |
125981111 | 12598111 | 3 | Pain |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
125981111 | 12598111 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
125981111 | 12598111 | Device failure | |
125981111 | 12598111 | Drug withdrawal syndrome | |
125981111 | 12598111 | Hyperhidrosis | |
125981111 | 12598111 | Off label use | |
125981111 | 12598111 | Pain |
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 |
---|---|---|---|---|---|---|
125981111 | 12598111 | 5 | 20150211 | 0 | ||
125981111 | 12598111 | 6 | 20101221 | 0 | ||
125981111 | 12598111 | 7 | 20140917 | 0 | ||
125981111 | 12598111 | 9 | 20090408 | 0 |