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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127393021 | 12739302 | 1 | I | 2014 | 20160405 | 20160913 | 20160913 | EXP | PHHY2016US048902 | SANDOZ | 0.00 | F | Y | 0.00000 | 20160913 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127393021 | 12739302 | 1 | SS | BACLOFEN INTRATHECAL | BACLOFEN | 1 | Intrathecal | 70 UG, QD | U | 0 | 70 | UG | AMPOULE | QD | |||||
| 127393021 | 12739302 | 2 | SS | BACLOFEN. | BACLOFEN | 1 | Unknown | UNK MG, UNK | U | 0 | |||||||||
| 127393021 | 12739302 | 3 | SS | BACLOFEN INTRATHECAL | BACLOFEN | 1 | Intrathecal | 70 UG, QD | Y | 0 | 70 | UG | AMPOULE | QD | |||||
| 127393021 | 12739302 | 4 | PS | TIZANIDINE. | TIZANIDINE | 1 | Unknown | , UNK | U | 76280 | |||||||||
| 127393021 | 12739302 | 5 | SS | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | Intrathecal | 3.78 MG, QD | Y | 0 | 3.78 | MG | QD | ||||||
| 127393021 | 12739302 | 6 | SS | FENTANYL. | FENTANYL | 1 | Intrathecal | 630 MG, QD | Y | 0 | 630 | MG | QD | ||||||
| 127393021 | 12739302 | 7 | SS | BUPIVACAINE. | BUPIVACAINE | 1 | Intrathecal | 7.6 MG, QD | Y | 0 | 7.6 | MG | QD | ||||||
| 127393021 | 12739302 | 8 | SS | REMERON | MIRTAZAPINE | 1 | Unknown | UNK, UNK | U | 0 | |||||||||
| 127393021 | 12739302 | 9 | SS | TOPAMAX | TOPIRAMATE | 1 | Unknown | , UNK | U | 0 | |||||||||
| 127393021 | 12739302 | 10 | SS | MIDRIN | ACETAMINOPHENDICHLORALPHENAZONEISOMETHEPTENE | 1 | Unknown | U | 0 | ||||||||||
| 127393021 | 12739302 | 11 | SS | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Unknown | , UNK | U | 0 | |||||||||
| 127393021 | 12739302 | 12 | SS | LEXAPRO | ESCITALOPRAM OXALATE | 1 | Unknown | U | 0 | ||||||||||
| 127393021 | 12739302 | 13 | SS | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | Unknown | , UNK | U | 0 | |||||||||
| 127393021 | 12739302 | 14 | C | DIAZEPAM. | DIAZEPAM | 1 | Unknown | U | 0 | ||||||||||
| 127393021 | 12739302 | 15 | C | PERCOCET | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127393021 | 12739302 | 1 | Pain |
| 127393021 | 12739302 | 2 | Product used for unknown indication |
| 127393021 | 12739302 | 3 | Product used for unknown indication |
| 127393021 | 12739302 | 4 | Product used for unknown indication |
| 127393021 | 12739302 | 5 | Product used for unknown indication |
| 127393021 | 12739302 | 6 | Product used for unknown indication |
| 127393021 | 12739302 | 7 | Product used for unknown indication |
| 127393021 | 12739302 | 8 | Product used for unknown indication |
| 127393021 | 12739302 | 9 | Product used for unknown indication |
| 127393021 | 12739302 | 10 | Product used for unknown indication |
| 127393021 | 12739302 | 11 | Product used for unknown indication |
| 127393021 | 12739302 | 12 | Product used for unknown indication |
| 127393021 | 12739302 | 13 | Product used for unknown indication |
| 127393021 | 12739302 | 14 | Product used for unknown indication |
| 127393021 | 12739302 | 15 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127393021 | 12739302 | HO |
| 127393021 | 12739302 | DS |
| 127393021 | 12739302 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127393021 | 12739302 | Alopecia | |
| 127393021 | 12739302 | Bedridden | |
| 127393021 | 12739302 | Cardiac disorder | |
| 127393021 | 12739302 | Catheter site swelling | |
| 127393021 | 12739302 | Chest discomfort | |
| 127393021 | 12739302 | Chest pain | |
| 127393021 | 12739302 | Chills | |
| 127393021 | 12739302 | Cognitive disorder | |
| 127393021 | 12739302 | Disturbance in attention | |
| 127393021 | 12739302 | Drug withdrawal syndrome | |
| 127393021 | 12739302 | Dry skin | |
| 127393021 | 12739302 | Dyspnoea | |
| 127393021 | 12739302 | Fall | |
| 127393021 | 12739302 | Fatigue | |
| 127393021 | 12739302 | General physical condition abnormal | |
| 127393021 | 12739302 | Headache | |
| 127393021 | 12739302 | Heart rate increased | |
| 127393021 | 12739302 | Hyperhidrosis | |
| 127393021 | 12739302 | Influenza | |
| 127393021 | 12739302 | Loss of consciousness | |
| 127393021 | 12739302 | Malaise | |
| 127393021 | 12739302 | Muscle spasms | |
| 127393021 | 12739302 | Muscle spasticity | |
| 127393021 | 12739302 | Muscular weakness | |
| 127393021 | 12739302 | Nasopharyngitis | |
| 127393021 | 12739302 | Nightmare | |
| 127393021 | 12739302 | Off label use | |
| 127393021 | 12739302 | Overdose | |
| 127393021 | 12739302 | Pain | |
| 127393021 | 12739302 | Paraesthesia | |
| 127393021 | 12739302 | Performance status decreased | |
| 127393021 | 12739302 | Post lumbar puncture syndrome | |
| 127393021 | 12739302 | Pruritus | |
| 127393021 | 12739302 | Road traffic accident | |
| 127393021 | 12739302 | Toxicity to various agents | |
| 127393021 | 12739302 | Tremor | |
| 127393021 | 12739302 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 127393021 | 12739302 | 3 | 20150603 | 0 | ||
| 127393021 | 12739302 | 5 | 20150603 | 0 | ||
| 127393021 | 12739302 | 6 | 20150603 | 0 | ||
| 127393021 | 12739302 | 7 | 20150603 | 0 |