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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125229222 | 12522922 | 2 | F | 20151104 | 20160729 | 20160701 | 20160812 | EXP | US-SAOL THERAPEUTICS-2016SAO00003 | SAOL THERAPEUTICS | 56.77 | YR | F | Y | 0.00000 | 20160811 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125229222 | 12522922 | 1 | PS | BACLOFEN. | BACLOFEN | 1 | Intrathecal | 230 ?G, 1X/DAY | Y | U | 10262015426964 | 20075 | 230 | UG | INJECTION | QD | |||
| 125229222 | 12522922 | 2 | SS | CLONIDINE. | CLONIDINE | 1 | Intrathecal | 230 ?G, 1X/DAY | U | U | 0 | 230 | UG | QD | |||||
| 125229222 | 12522922 | 3 | SS | MORPHINE | MORPHINE | 1 | Intrathecal | 17.2 MG, 1X/DAY | Y | U | 0 | 17.2 | MG | QD | |||||
| 125229222 | 12522922 | 4 | SS | FENTANYL. | FENTANYL | 1 | Transdermal | 0 | |||||||||||
| 125229222 | 12522922 | 5 | C | UNSPECIFIED ORAL MEDICATION | UNSPECIFIED INGREDIENT | 1 | Oral | UNK | 0 | ||||||||||
| 125229222 | 12522922 | 6 | C | PROMETHAZINE | PROMETHAZINEPROMETHAZINE HYDROCHLORIDE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125229222 | 12522922 | 1 | Pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125229222 | 12522922 | DS |
| 125229222 | 12522922 | OT |
| 125229222 | 12522922 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125229222 | 12522922 | Activities of daily living impaired | |
| 125229222 | 12522922 | Back pain | |
| 125229222 | 12522922 | Device malfunction | |
| 125229222 | 12522922 | Drug withdrawal syndrome | |
| 125229222 | 12522922 | Fall | |
| 125229222 | 12522922 | Malaise | |
| 125229222 | 12522922 | Muscle tightness | |
| 125229222 | 12522922 | Pain | |
| 125229222 | 12522922 | Therapeutic response decreased | |
| 125229222 | 12522922 | Urine analysis abnormal | |
| 125229222 | 12522922 | Vomiting | |
| 125229222 | 12522922 | 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 |
|---|---|---|---|---|---|---|
| 125229222 | 12522922 | 1 | 20151112 | 0 | ||
| 125229222 | 12522922 | 2 | 20151112 | 0 | ||
| 125229222 | 12522922 | 3 | 20151112 | 0 |