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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8016636 | 8150572 | F | 8016636-5 | 20110831 | 20111228 | 20111231 | EXP | PHEH2011US04686 | SANDOZ,INC. | 34 | YR | F | Y | 20111231 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 8016636 | 1018419957 | SS | GILENYA | 1 | ORAL | 0.5 MG, QD | |||||
| 8016636 | 1018419961 | C | VICODIN | 1 | ORAL | 5 MG, BID | |||||
| 8016636 | 1018419962 | C | ZOLOFT | 1 | ORAL | 50 MG, QD | |||||
| 8016636 | 1018419958 | PS | ALPRAZOLAM | 1 | 074112 | ||||||
| 8016636 | 1018419959 | SS | HYDROCODONE BITARTRATE | 1 | |||||||
| 8016636 | 1018419960 | C | XANAX | 1 | ORAL | 2 MG, TID | |||||
| 8016636 | 1018419963 | C | NEURONTIN | 1 | ORAL | 300 MG, TID |
Indications of drugs used
| Event ID | DRUG SEQ | INDI PT |
|---|---|---|
| 8016636 | 1018419957 | MULTIPLE SCLEROSIS |
| 8016636 | 1018419961 | PAIN |
| 8016636 | 1018419962 | DEPRESSED MOOD |
| 8016636 | 1018419960 | TREMOR |
| 8016636 | 1018419963 | TREMOR |
Outcome of event
| Event ID | OUTC COD |
|---|---|
| 8016636 | DE |
| 8016636 | OT |
Reactions reported
| Event ID | PT |
|---|---|
| 8016636 | ATRIOVENTRICULAR BLOCK SECOND DEGREE |
| 8016636 | DROWNING |
| 8016636 | MOBILITY DECREASED |
| 8016636 | PROGRESSIVE RELAPSING MULTIPLE SCLEROSIS |
| 8016636 | ASTHENIA |
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 |
|---|---|---|---|---|---|
| 8016636 | 1018419957 | 20110831 | |||
| 8016636 | 1018419961 | 20110701 | 20110901 | ||
| 8016636 | 1018419962 | 20110901 | |||
| 8016636 | 1018419960 | 20110701 | 20110901 | ||
| 8016636 | 1018419963 | 20110701 | 20110901 |