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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127463391 | 12746339 | 1 | I | 20140905 | 20160913 | 20160915 | 20160915 | EXP | GB-JNJFOC-20160913186 | JANSSEN | 55.00 | YR | A | M | Y | 0.00000 | 20160915 | CN | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127463391 | 12746339 | 1 | PS | FENTANYL. | FENTANYL | 1 | Unknown | N | HAMELN PHARMACEUTICALS | 19813 | 100 | DF | UNSPECIFIED | ||||||
| 127463391 | 12746339 | 2 | SS | LIDOCAINE. | LIDOCAINE | 1 | Unknown | B BRAUN | 0 | 30 | DF | UNSPECIFIED | |||||||
| 127463391 | 12746339 | 3 | SS | TRIAMCINOLONE | TRIAMCINOLONE | 1 | Unknown | SQUIBB | 0 | 86 | DF | UNSPECIFIED | |||||||
| 127463391 | 12746339 | 4 | SS | NORMAL SALINE | SODIUM CHLORIDE | 1 | Unknown | FENNING | 0 | UNSPECIFIED | |||||||||
| 127463391 | 12746339 | 5 | SS | MIDAZOLAM | MIDAZOLAMMIDAZOLAM HYDROCHLORIDE | 1 | Unknown | MERCURY PHARMA | 0 | 5 | DF | UNSPECIFIED | |||||||
| 127463391 | 12746339 | 6 | SS | LEVOBUPIVACAINE HYDROCHLORIDE | LEVOBUPIVACAINE HYDROCHLORIDE | 1 | Unknown | ABBOTT | 0 | 13 | DF | UNSPECIFIED | |||||||
| 127463391 | 12746339 | 7 | C | GABAPENTIN. | GABAPENTIN | 1 | Unknown | PLUS EXTRA DOSE AT NIGHT | 0 | 400 | DF | UNSPECIFIED | |||||||
| 127463391 | 12746339 | 8 | C | EPILIM | VALPROATE SODIUM | 1 | Unknown | 0 | 100 | DF | UNSPECIFIED | QD | |||||||
| 127463391 | 12746339 | 9 | C | GLUCOSAMINE SULPHATE | GLUCOSAMINE | 1 | Unknown | 0 | 2 | DF | UNSPECIFIED | QD | |||||||
| 127463391 | 12746339 | 10 | C | CLONAZEPAM. | CLONAZEPAM | 1 | Unknown | 0 | 2 | DF | UNSPECIFIED | BID | |||||||
| 127463391 | 12746339 | 11 | C | RANITIDINE. | RANITIDINE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 127463391 | 12746339 | 12 | C | MORPHINE SULFATE. | MORPHINE SULFATE | 1 | Unknown | 10MG/5ML | 0 | UNSPECIFIED | |||||||||
| 127463391 | 12746339 | 13 | C | TRAMADOL. | TRAMADOL | 1 | Unknown | ONE OR TWO TIMES DAILY | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127463391 | 12746339 | 1 | Sedation |
| 127463391 | 12746339 | 2 | Sedation |
| 127463391 | 12746339 | 3 | Sedation |
| 127463391 | 12746339 | 4 | Sedation |
| 127463391 | 12746339 | 5 | Sedation |
| 127463391 | 12746339 | 6 | Sedation |
| 127463391 | 12746339 | 12 | Breakthrough pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127463391 | 12746339 | DS |
| 127463391 | 12746339 | HO |
| 127463391 | 12746339 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127463391 | 12746339 | Ageusia | |
| 127463391 | 12746339 | Amnesia | |
| 127463391 | 12746339 | Circulatory collapse | |
| 127463391 | 12746339 | Decreased appetite | |
| 127463391 | 12746339 | Discomfort | |
| 127463391 | 12746339 | Dissociative amnesia | |
| 127463391 | 12746339 | Dysgeusia | |
| 127463391 | 12746339 | Dysgraphia | |
| 127463391 | 12746339 | Erythema | |
| 127463391 | 12746339 | Eye pain | |
| 127463391 | 12746339 | Facial paralysis | |
| 127463391 | 12746339 | Hallucination | |
| 127463391 | 12746339 | Headache | |
| 127463391 | 12746339 | Hemiparesis | |
| 127463391 | 12746339 | Hypoaesthesia oral | |
| 127463391 | 12746339 | Loss of consciousness | |
| 127463391 | 12746339 | Muscle spasms | |
| 127463391 | 12746339 | Muscle twitching | |
| 127463391 | 12746339 | Muscular weakness | |
| 127463391 | 12746339 | Musculoskeletal stiffness | |
| 127463391 | 12746339 | Mydriasis | |
| 127463391 | 12746339 | Nausea | |
| 127463391 | 12746339 | Nightmare | |
| 127463391 | 12746339 | Ocular hyperaemia | |
| 127463391 | 12746339 | Pain | |
| 127463391 | 12746339 | Photosensitivity reaction | |
| 127463391 | 12746339 | Rash | |
| 127463391 | 12746339 | Skin warm | |
| 127463391 | 12746339 | Speech disorder | |
| 127463391 | 12746339 | Unresponsive to stimuli |
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 |
|---|---|---|---|---|---|---|
| 127463391 | 12746339 | 1 | 20140904 | 20140904 | 0 | |
| 127463391 | 12746339 | 2 | 20140904 | 20140904 | 0 | |
| 127463391 | 12746339 | 3 | 20140904 | 20140904 | 0 | |
| 127463391 | 12746339 | 4 | 20140904 | 20140904 | 0 | |
| 127463391 | 12746339 | 5 | 20140904 | 20140904 | 0 | |
| 127463391 | 12746339 | 6 | 20140904 | 20140904 | 0 |