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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7386001 | 7879574 | I | 7386001-2 | 20100401 | 20110322 | 20110331 | EXP | FR-SHIRE-SPV1-2011-00495 | SHIRE DEVELOPMENT INC | 83 | YR | M | Y | 20110331 | OT | FRANCE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 7386001 | 1016135956 | C | ACETAMINOPHEN AND TRAMADOL HCL | 1 | UNKNOWN | UNK, UNKNOWN | |||||
| 7386001 | 1016135959 | C | VERAPAMIL | 1 | UNKNOWN | UNK, UNKNOWN | |||||
| 7386001 | 1016135953 | PS | XAGRID | 2 | ORAL | FROM 0.5 MG TO 1 MG TO 1.5 MG TO 2 MG DAILY | 020333 | ||||
| 7386001 | 1016135957 | C | ALLOPURINOL | 1 | UNKNOWN | UNK, UNKNOWN | |||||
| 7386001 | 1016135958 | C | KARDEGIC | 2 | UNKNOWN | UNK, UNKNOWN | |||||
| 7386001 | 1016135955 | C | ZESTORETIC | 1 | UNKNOWN | UNK, UNKNOWN | |||||
| 7386001 | 1016135954 | C | HYDREA | 1 | UNKNOWN | UNK UNK, UNKNOWN |
Indications of drugs used
| Event ID | DRUG SEQ | INDI PT |
|---|---|---|
| 7386001 | 1016135956 | PRODUCT USED FOR UNKNOWN INDICATION |
| 7386001 | 1016135959 | PRODUCT USED FOR UNKNOWN INDICATION |
| 7386001 | 1016135953 | THROMBOCYTOSIS |
| 7386001 | 1016135957 | PRODUCT USED FOR UNKNOWN INDICATION |
| 7386001 | 1016135958 | PRODUCT USED FOR UNKNOWN INDICATION |
| 7386001 | 1016135955 | PRODUCT USED FOR UNKNOWN INDICATION |
| 7386001 | 1016135954 | PRODUCT USED FOR UNKNOWN INDICATION |
Outcome of event
| Event ID | OUTC COD |
|---|---|
| 7386001 | HO |
Reactions reported
| Event ID | PT |
|---|---|
| 7386001 | MALAISE |
| 7386001 | ASTHENIA |
| 7386001 | LOSS OF CONSCIOUSNESS |
| 7386001 | HAEMOGLOBIN DECREASED |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|
| 7386001 | 1016135953 | 20090201 | |||
| 7386001 | 1016135954 | 20040101 |