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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127182651 | 12718265 | 1 | I | 201601 | 20160316 | 20160906 | 20160906 | EXP | US-SAOL THERAPEUTICS-2016SAO00541 | SAOL THERAPEUTICS | 53.37 | YR | F | Y | 0.00000 | 20160906 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127182651 | 12718265 | 1 | PS | BACLOFEN. | BACLOFEN | 1 | Intrathecal | 19.98 ?G,DAY | U | U | 20075 | 19.98 | UG | INJECTION | QD | ||||
| 127182651 | 12718265 | 2 | SS | FENTANYL. | FENTANYL | 1 | Intrathecal | U | 0 | ||||||||||
| 127182651 | 12718265 | 3 | SS | CLONIDINE. | CLONIDINE | 1 | Intrathecal | U | 0 | ||||||||||
| 127182651 | 12718265 | 4 | SS | BUPIVACAINE. | BUPIVACAINE | 1 | Intrathecal | 3.59 MG/DAY | U | 0 | 3.59 | MG | QD | ||||||
| 127182651 | 12718265 | 5 | SS | MORPHINE | MORPHINE | 1 | Intrathecal | 5.99 MG/DAY | U | 0 | 5.99 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127182651 | 12718265 | 1 | Spinal pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127182651 | 12718265 | HO |
| 127182651 | 12718265 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127182651 | 12718265 | Fatigue | |
| 127182651 | 12718265 | Multiple sclerosis relapse | |
| 127182651 | 12718265 | Muscle spasms | |
| 127182651 | 12718265 | Pneumonia | |
| 127182651 | 12718265 | Pyrexia | |
| 127182651 | 12718265 | Somnolence |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |