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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 102310448 | 10231044 | 8 | F | 2013 | 20151221 | 20140611 | 20151231 | EXP | US-SANOFI-AVENTIS-2013SA059607 | AVENTIS | 65.00 | YR | A | M | Y | 102.00000 | KG | 20151231 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 102310448 | 10231044 | 1 | PS | AUBAGIO | TERIFLUNOMIDE | 1 | Oral | 2G95DSA | 202992 | 14 | MG | COATED TABLET | QD | ||||||
| 102310448 | 10231044 | 2 | SS | AUBAGIO | TERIFLUNOMIDE | 1 | Oral | 2G95GSA | 202992 | 14 | MG | COATED TABLET | QD | ||||||
| 102310448 | 10231044 | 3 | SS | AUBAGIO | TERIFLUNOMIDE | 1 | Oral | UNKNOWN | 202992 | 14 | MG | COATED TABLET | QD | ||||||
| 102310448 | 10231044 | 4 | SS | AUBAGIO | TERIFLUNOMIDE | 1 | Oral | UNKNOWN | 202992 | 14 | MG | QD | |||||||
| 102310448 | 10231044 | 5 | SS | AUBAGIO | TERIFLUNOMIDE | 1 | Oral | UNK | 202992 | 14 | MG | QD | |||||||
| 102310448 | 10231044 | 6 | SS | AUBAGIO | TERIFLUNOMIDE | 1 | Oral | UNKNOWN | 202992 | 14 | MG | QD | |||||||
| 102310448 | 10231044 | 7 | C | LISINOPRIL. | LISINOPRIL | 1 | Unknown | 0 | 40 | MG | |||||||||
| 102310448 | 10231044 | 8 | C | OXYBUTYNIN | OXYBUTYNIN | 1 | 0 | 5 | MG | ||||||||||
| 102310448 | 10231044 | 9 | C | TAMSULOSIN | TAMSULOSIN | 1 | 0 | .4 | MG | CAPSULE | |||||||||
| 102310448 | 10231044 | 10 | C | FINASTERIDE. | FINASTERIDE | 1 | 0 | 5 | MG | QD | |||||||||
| 102310448 | 10231044 | 11 | C | TIZANIDINE. | TIZANIDINE | 1 | 0 | 4 | MG | QID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 102310448 | 10231044 | 1 | Relapsing-remitting multiple sclerosis |
| 102310448 | 10231044 | 2 | Relapsing-remitting multiple sclerosis |
| 102310448 | 10231044 | 3 | Relapsing-remitting multiple sclerosis |
| 102310448 | 10231044 | 4 | Relapsing-remitting multiple sclerosis |
| 102310448 | 10231044 | 5 | Relapsing-remitting multiple sclerosis |
| 102310448 | 10231044 | 6 | Relapsing-remitting multiple sclerosis |
| 102310448 | 10231044 | 7 | Blood pressure measurement |
| 102310448 | 10231044 | 8 | Prostatic disorder |
| 102310448 | 10231044 | 9 | Prostatic disorder |
| 102310448 | 10231044 | 10 | Bladder disorder |
| 102310448 | 10231044 | 11 | Muscle spasticity |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 102310448 | 10231044 | OT |
| 102310448 | 10231044 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 102310448 | 10231044 | Alanine aminotransferase increased | |
| 102310448 | 10231044 | Asthenia | |
| 102310448 | 10231044 | Back pain | |
| 102310448 | 10231044 | Balance disorder | |
| 102310448 | 10231044 | Drug dose omission | |
| 102310448 | 10231044 | Fall | |
| 102310448 | 10231044 | Fatigue | |
| 102310448 | 10231044 | Flushing | |
| 102310448 | 10231044 | Hip arthroplasty | |
| 102310448 | 10231044 | Ill-defined disorder | |
| 102310448 | 10231044 | Impaired healing | |
| 102310448 | 10231044 | Oral herpes | |
| 102310448 | 10231044 | Pain in extremity | |
| 102310448 | 10231044 | Sciatica |
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 |
|---|---|---|---|---|---|---|
| 102310448 | 10231044 | 1 | 20130525 | 20140219 | 0 | |
| 102310448 | 10231044 | 2 | 20130525 | 20140219 | 0 | |
| 102310448 | 10231044 | 3 | 20150111 | 0 | ||
| 102310448 | 10231044 | 4 | 20150212 | 20150302 | 0 | |
| 102310448 | 10231044 | 5 | 20150428 | 20151114 | 0 | |
| 102310448 | 10231044 | 6 | 20151215 | 0 |