Person who experienced the adverse event (patient)
| Event ID | CASE | I F COD | FOLL SEQ | IMAGE | EVENT DT | MFR DT | FDA DT | REPT COD | MFR NUM | MFR SNDR | AGE | AGE COD | GNDR COD | E SUB | WT | WT COD | REPT DT | OCCP COD | DEATH DT | TO MFR | CONFID | REPORTER COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 5797497 | 6695311 | I | 5797497-1 | 20080101 | 20080611 | 20080630 | EXP | 8033749 | UCB, INC. | 61 | YR | F | N | 20080623 | CN | UNITED STATES |
Drug(s) used by person
| Event ID | DRUG SEQ | ROLE COD | DRUGNAME | VAL VBM | ROUTE | DOSE VBM | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 5797497 | 1010120676 | PS | KEPPRA | 1 | D | 21035 | |||||
| 5797497 | 1010152468 | SS | ATARAX | 1 | 25 MG 3/D | D | |||||
| 5797497 | 1010152501 | SS | LYRICA | 1 | D | ||||||
| 5797497 | 1010152504 | SS | LYRICA | 1 | 100 MG 2/D | D | |||||
| 5797497 | 1010152508 | SS | NORVASC | 1 | 10 MG /D | ||||||
| 5797497 | 1010152511 | SS | ANTIVERT /00042802/ | 2 | D | ||||||
| 5797497 | 1010152513 | SS | DURAGESIC-100 | 1 | D | D | |||||
| 5797497 | 1010152514 | SS | DURAGESIC-100 | 1 | 25 MCG | D | D | ||||
| 5797497 | 1010152525 | SS | MORPHINE | 1 | D | ||||||
| 5797497 | 1010152527 | SS | MORPHINE | 1 | D | ||||||
| 5797497 | 1010152625 | C | ZANTAC | 1 |
Indications of drugs used
| Event ID | DRUG SEQ | INDI PT |
|---|---|---|
| 5797497 | 1010120676 | ESSENTIAL TREMOR |
| 5797497 | 1010152468 | PRURITUS |
| 5797497 | 1010152501 | NEUROPATHY PERIPHERAL |
| 5797497 | 1010152504 | NEUROPATHY PERIPHERAL |
| 5797497 | 1010152511 | DIZZINESS |
| 5797497 | 1010152513 | NEUROPATHY PERIPHERAL |
| 5797497 | 1010152514 | NEUROPATHY PERIPHERAL |
| 5797497 | 1010152525 | BREAKTHROUGH PAIN |
| 5797497 | 1010152527 | BREAKTHROUGH PAIN |
Outcome of event
| Event ID | OUTC COD |
|---|---|
| 5797497 | HO |
Reactions reported
| Event ID | PT |
|---|---|
| 5797497 | ACUTE MYELOID LEUKAEMIA |
| 5797497 | BLAST CELLS ABSENT |
| 5797497 | COMA |
| 5797497 | CYTOGENETIC ABNORMALITY |
| 5797497 | DIZZINESS |
| 5797497 | DRUG HYPERSENSITIVITY |
| 5797497 | DRUG INTERACTION |
| 5797497 | DYSKINESIA |
| 5797497 | ESSENTIAL TREMOR |
| 5797497 | FEAR |
| 5797497 | INFECTION |
| 5797497 | NEUTROPENIA |
| 5797497 | PERICARDIAL EFFUSION |
| 5797497 | PLEURAL EFFUSION |
| 5797497 | RASH ERYTHEMATOUS |
| 5797497 | RASH GENERALISED |
| 5797497 | REACTION TO DRUG EXCIPIENTS |
Reporting Sources (this data is often not reported and may therefore be missing here)
| Event ID | RPSR COD |
|---|---|
| 5797497 | CSM |
Therapies reported
| Event ID | DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|
| 5797497 | 1010120676 | 20080309 | 20080309 | ||
| 5797497 | 1010152468 | 20080301 | |||
| 5797497 | 1010152501 | 20080101 | |||
| 5797497 | 1010152504 | 20080523 | 20080611 | ||
| 5797497 | 1010152508 | 20080301 | |||
| 5797497 | 1010152511 | 20080301 |