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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1014385913 | 10143859 | 13 | F | 2013 | 20160622 | 20140430 | 20160630 | EXP | US-SA-2013SA117700 | AVENTIS | 56.00 | YR | A | F | Y | 54.00000 | KG | 20160630 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1014385913 | 10143859 | 1 | PS | AUBAGIO | TERIFLUNOMIDE | 1 | Oral | 2694ESB | 202992 | 7 | MG | COATED TABLET | QD | ||||||
| 1014385913 | 10143859 | 2 | SS | AUBAGIO | TERIFLUNOMIDE | 1 | Oral | 2CK3DSA | 202992 | 7 | MG | COATED TABLET | QD | ||||||
| 1014385913 | 10143859 | 3 | SS | AUBAGIO | TERIFLUNOMIDE | 1 | Oral | 5C74ASA | 202992 | 14 | MG | COATED TABLET | QD | ||||||
| 1014385913 | 10143859 | 4 | SS | AUBAGIO | TERIFLUNOMIDE | 1 | Oral | 5C74ASA | 202992 | 7 | MG | COATED TABLET | QD | ||||||
| 1014385913 | 10143859 | 5 | SS | NEURONTIN | GABAPENTIN | 1 | Unknown | UNK | 0 | ||||||||||
| 1014385913 | 10143859 | 6 | SS | NEURONTIN | GABAPENTIN | 1 | Unknown | UNK | 0 | 300 | MG | BID | |||||||
| 1014385913 | 10143859 | 7 | SS | NEURONTIN | GABAPENTIN | 1 | Unknown | UNK | 0 | 100 | MG | BID | |||||||
| 1014385913 | 10143859 | 8 | C | LOMOTIL | ATROPINE SULFATEDIPHENOXYLATE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 1014385913 | 10143859 | 9 | C | LOMOTIL | ATROPINE SULFATEDIPHENOXYLATE HYDROCHLORIDE | 1 | 0 | 2.5 | MG | ||||||||||
| 1014385913 | 10143859 | 10 | C | ALPRAZOLAM. | ALPRAZOLAM | 1 | 0 | 1 | MG | TID | |||||||||
| 1014385913 | 10143859 | 11 | C | REMERON | MIRTAZAPINE | 1 | BEDTIME | 0 | 45 | MG | QD | ||||||||
| 1014385913 | 10143859 | 12 | C | REMERON | MIRTAZAPINE | 1 | STRENGTH: 15 MG | 0 | 1 | DF | TABLET | ||||||||
| 1014385913 | 10143859 | 13 | C | TIZANIDINE. | TIZANIDINE | 1 | BEDTIME | 0 | 2 | MG | QD | ||||||||
| 1014385913 | 10143859 | 14 | C | ZOLPIDEM | ZOLPIDEMOLPIDEM TARTRATE | 1 | BEDTIME | 0 | 10 | MG | QD | ||||||||
| 1014385913 | 10143859 | 15 | C | ESTRADIOL. | ESTRADIOL | 1 | 0.375 ?1 DOT 2 TIMES A WEEK | 0 | BIW | ||||||||||
| 1014385913 | 10143859 | 16 | C | PROGESTERONE. | PROGESTERONE | 1 | COMPOUND CREAM APPLY AT BEDTIME | 0 | 4 | ML | CREAM | QD | |||||||
| 1014385913 | 10143859 | 17 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | 0 | 3000 | IU | ||||||||||
| 1014385913 | 10143859 | 18 | C | CALCIUM PHOSPHATE DIBASIC/FERROUS SUCCINATE/MAGNESIUM HYDROXIDE | 2 | 1 IN AM AND 1 IN PM | 0 | 50 | MG | BID | |||||||||
| 1014385913 | 10143859 | 19 | C | LIDOCAINE. | LIDOCAINE | 1 | 5% PATCH?1 PATCH DAILY?12 HRS ON/12 OFF | 0 | |||||||||||
| 1014385913 | 10143859 | 20 | C | IRON | IRON | 1 | THRICE WEEKLY | 0 | 325 | MG | |||||||||
| 1014385913 | 10143859 | 21 | C | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 1014385913 | 10143859 | 22 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | 0 | ||||||||||||
| 1014385913 | 10143859 | 23 | C | BUSPAR | BUSPIRONE HYDROCHLORIDE | 1 | 0 | 15 | MG | BID | |||||||||
| 1014385913 | 10143859 | 24 | C | ESTRADIOL/NORETHINDRONE ACETATE | 2 | TRANSDERMAL PATCH | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1014385913 | 10143859 | 1 | Multiple sclerosis |
| 1014385913 | 10143859 | 2 | Multiple sclerosis |
| 1014385913 | 10143859 | 3 | Multiple sclerosis |
| 1014385913 | 10143859 | 4 | Multiple sclerosis |
| 1014385913 | 10143859 | 10 | Anxiety |
| 1014385913 | 10143859 | 11 | Depression |
| 1014385913 | 10143859 | 12 | Depression |
| 1014385913 | 10143859 | 13 | Muscle spasms |
| 1014385913 | 10143859 | 14 | Sleep disorder |
| 1014385913 | 10143859 | 15 | Menopause |
| 1014385913 | 10143859 | 16 | Menopause |
| 1014385913 | 10143859 | 18 | Red blood cell count decreased |
| 1014385913 | 10143859 | 19 | Pain |
| 1014385913 | 10143859 | 20 | Blood iron decreased |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1014385913 | 10143859 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1014385913 | 10143859 | Abdominal discomfort | |
| 1014385913 | 10143859 | Abdominal distension | |
| 1014385913 | 10143859 | Abnormal faeces | |
| 1014385913 | 10143859 | Alopecia | |
| 1014385913 | 10143859 | Anxiety | |
| 1014385913 | 10143859 | Back pain | |
| 1014385913 | 10143859 | Balance disorder | |
| 1014385913 | 10143859 | Burning sensation | |
| 1014385913 | 10143859 | Carpal tunnel syndrome | |
| 1014385913 | 10143859 | Cognitive disorder | |
| 1014385913 | 10143859 | Condition aggravated | |
| 1014385913 | 10143859 | Diarrhoea | |
| 1014385913 | 10143859 | Dry mouth | |
| 1014385913 | 10143859 | Dysphagia | |
| 1014385913 | 10143859 | Eating disorder | |
| 1014385913 | 10143859 | Economic problem | |
| 1014385913 | 10143859 | Electromyogram abnormal | |
| 1014385913 | 10143859 | Erythema | |
| 1014385913 | 10143859 | Exophthalmos | |
| 1014385913 | 10143859 | Fall | |
| 1014385913 | 10143859 | Fatigue | |
| 1014385913 | 10143859 | Feeling abnormal | |
| 1014385913 | 10143859 | Feeling cold | |
| 1014385913 | 10143859 | Frequent bowel movements | |
| 1014385913 | 10143859 | Gallbladder non-functioning | |
| 1014385913 | 10143859 | Gastrointestinal disorder | |
| 1014385913 | 10143859 | Gastrooesophageal reflux disease | |
| 1014385913 | 10143859 | Hair growth abnormal | |
| 1014385913 | 10143859 | Hepatic enzyme increased | |
| 1014385913 | 10143859 | Hormone level abnormal | |
| 1014385913 | 10143859 | Hot flush | |
| 1014385913 | 10143859 | Hypoaesthesia | |
| 1014385913 | 10143859 | Hypoaesthesia oral | |
| 1014385913 | 10143859 | Limb discomfort | |
| 1014385913 | 10143859 | Lip dry | |
| 1014385913 | 10143859 | Loss of employment | |
| 1014385913 | 10143859 | Malaise | |
| 1014385913 | 10143859 | Muscular weakness | |
| 1014385913 | 10143859 | Musculoskeletal discomfort | |
| 1014385913 | 10143859 | Myalgia | |
| 1014385913 | 10143859 | Nasopharyngitis | |
| 1014385913 | 10143859 | Nervousness | |
| 1014385913 | 10143859 | Pain | |
| 1014385913 | 10143859 | Pain in extremity | |
| 1014385913 | 10143859 | Paraesthesia | |
| 1014385913 | 10143859 | Peroneal nerve palsy | |
| 1014385913 | 10143859 | Renal disorder | |
| 1014385913 | 10143859 | Road traffic accident | |
| 1014385913 | 10143859 | Sensation of foreign body | |
| 1014385913 | 10143859 | Sensory disturbance | |
| 1014385913 | 10143859 | Stress | |
| 1014385913 | 10143859 | Swelling | |
| 1014385913 | 10143859 | Swollen tongue | |
| 1014385913 | 10143859 | Thyroid function test abnormal | |
| 1014385913 | 10143859 | Tongue discolouration | |
| 1014385913 | 10143859 | Ulnar nerve injury | |
| 1014385913 | 10143859 | Vitamin B6 increased | |
| 1014385913 | 10143859 | Vomiting | |
| 1014385913 | 10143859 | Weight decreased | |
| 1014385913 | 10143859 | Weight fluctuation | |
| 1014385913 | 10143859 | Weight increased | |
| 1014385913 | 10143859 | White blood cell count decreased |
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 |
|---|---|---|---|---|---|---|
| 1014385913 | 10143859 | 1 | 20131112 | 20140203 | 0 | |
| 1014385913 | 10143859 | 2 | 20131112 | 20140203 | 0 | |
| 1014385913 | 10143859 | 3 | 20140204 | 0 | ||
| 1014385913 | 10143859 | 4 | 20131112 | 20140203 | 0 | |
| 1014385913 | 10143859 | 9 | 201012 | 0 | ||
| 1014385913 | 10143859 | 10 | 201008 | 0 | ||
| 1014385913 | 10143859 | 11 | 201101 | 0 | ||
| 1014385913 | 10143859 | 12 | 201204 | 0 | ||
| 1014385913 | 10143859 | 13 | 201101 | 0 | ||
| 1014385913 | 10143859 | 14 | 201103 | 0 | ||
| 1014385913 | 10143859 | 16 | 201303 | 0 | ||
| 1014385913 | 10143859 | 17 | 201011 | 0 | ||
| 1014385913 | 10143859 | 18 | 201011 | 0 | ||
| 1014385913 | 10143859 | 19 | 201011 | 0 | ||
| 1014385913 | 10143859 | 20 | 201309 | 0 |