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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125292541 | 12529254 | 1 | I | 20160618 | 20160620 | 20160705 | 20160705 | PER | US-TEIKOKU PHARMA USA-TPU2016-00425 | TEIKOKU | 31.17 | YR | M | Y | 0.00000 | 20160705 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125292541 | 12529254 | 1 | PS | LIDOCAINE PATCH | LIDOCAINE | 1 | Topical | U | 65028 | 20612 | |||||||||
| 125292541 | 12529254 | 2 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 125292541 | 12529254 | 3 | C | COMPAZINE | PROCHLORPERAZINE MALEATE | 1 | Oral | 0 | |||||||||||
| 125292541 | 12529254 | 4 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 0 | |||||||||||
| 125292541 | 12529254 | 5 | C | METHADONE | METHADONE HYDROCHLORIDE | 1 | Oral | 0 | |||||||||||
| 125292541 | 12529254 | 6 | C | MORPHINE SULFATE. | MORPHINE SULFATE | 1 | Oral | 0 | |||||||||||
| 125292541 | 12529254 | 7 | C | LACTULOSE. | LACTULOSE | 1 | 0 | ||||||||||||
| 125292541 | 12529254 | 8 | C | LOPERAMIDE | LOPERAMIDE | 1 | 0 | ||||||||||||
| 125292541 | 12529254 | 9 | C | LORAZEPAM. | LORAZEPAM | 1 | 0 | ||||||||||||
| 125292541 | 12529254 | 10 | C | LORAZEPAM. | LORAZEPAM | 1 | 0 | ||||||||||||
| 125292541 | 12529254 | 11 | C | ROZEREM | RAMELTEON | 1 | 0 | ||||||||||||
| 125292541 | 12529254 | 12 | C | MIRALAX | POLYETHYLENE GLYCOL 3350 | 1 | Oral | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125292541 | 12529254 | 1 | Pain |
| 125292541 | 12529254 | 2 | Prophylaxis of nausea and vomiting |
| 125292541 | 12529254 | 3 | Prophylaxis of nausea and vomiting |
| 125292541 | 12529254 | 4 | Bone pain |
| 125292541 | 12529254 | 5 | Pain |
| 125292541 | 12529254 | 6 | Pain |
| 125292541 | 12529254 | 7 | Constipation |
| 125292541 | 12529254 | 8 | Diarrhoea |
| 125292541 | 12529254 | 9 | Anxiety |
| 125292541 | 12529254 | 10 | Nausea |
| 125292541 | 12529254 | 11 | Sleep disorder |
| 125292541 | 12529254 | 12 | Constipation |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125292541 | 12529254 | Application site rash | |
| 125292541 | 12529254 | Incorrect dose administered |
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 |
|---|---|---|---|---|---|---|
| 125292541 | 12529254 | 1 | 20160618 | 0 |