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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 104422433 | 10442243 | 3 | F | 20160705 | 20140909 | 20160712 | PER | PHEH2014US015230 | NOVARTIS | 0.00 | F | Y | 83.90000 | KG | 20160712 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 104422433 | 10442243 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 22527 | .5 | MG | CAPSULE | QD | ||||||
| 104422433 | 10442243 | 2 | SS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 22527 | .5 | MG | CAPSULE | QD | ||||||
| 104422433 | 10442243 | 3 | C | LIDOCAINE. | LIDOCAINE | 1 | Unknown | U | 0 | PATCH | |||||||||
| 104422433 | 10442243 | 4 | C | MORPHINE SULFATE. | MORPHINE SULFATE | 1 | Unknown | U | 0 | ||||||||||
| 104422433 | 10442243 | 5 | C | NYSTATIN. | NYSTATIN | 1 | Unknown | U | 0 | ||||||||||
| 104422433 | 10442243 | 6 | C | CLEARLAX | POLYETHYLENE GLYCOL 3350 | 1 | Unknown | U | 0 | ||||||||||
| 104422433 | 10442243 | 7 | C | DOCUSATE SODIUM. | DOCUSATE SODIUM | 1 | Unknown | U | 0 | ||||||||||
| 104422433 | 10442243 | 8 | C | CARISOPRODOL. | CARISOPRODOL | 1 | Unknown | U | 0 | ||||||||||
| 104422433 | 10442243 | 9 | C | DIAZEPAM. | DIAZEPAM | 1 | Unknown | U | 0 | ||||||||||
| 104422433 | 10442243 | 10 | C | ESCITALOPRAM OXALATE. | ESCITALOPRAM OXALATE | 1 | Unknown | U | 0 | ||||||||||
| 104422433 | 10442243 | 11 | C | HYDROCHLOORTHIAZIDE | HYDROCHLOROTHIAZIDE | 1 | Unknown | U | 0 | ||||||||||
| 104422433 | 10442243 | 12 | C | PROTONIX | PANTOPRAZOLE SODIUM | 1 | Unknown | U | 0 | ||||||||||
| 104422433 | 10442243 | 13 | C | IBUPROFEN. | IBUPROFEN | 1 | Unknown | U | 0 | ||||||||||
| 104422433 | 10442243 | 14 | C | LEVOTHYROXINE SODIUM. | LEVOTHYROXINE SODIUM | 1 | Unknown | U | 0 | ||||||||||
| 104422433 | 10442243 | 15 | C | LYRICA | PREGABALIN | 1 | Unknown | U | 0 | ||||||||||
| 104422433 | 10442243 | 16 | C | PROMETHAZINE | PROMETHAZINEPROMETHAZINE HYDROCHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 104422433 | 10442243 | 17 | C | CAMBIA | DICLOFENAC POTASSIUM | 1 | Unknown | U | 0 | ||||||||||
| 104422433 | 10442243 | 18 | C | ALBUTEROL. | ALBUTEROL | 1 | Unknown | U | 0 | ||||||||||
| 104422433 | 10442243 | 19 | C | SOMA | CARISOPRODOL | 1 | Unknown | U | 0 | ||||||||||
| 104422433 | 10442243 | 20 | C | OXYCODONE | OXYCODONE | 1 | Unknown | U | 0 | ||||||||||
| 104422433 | 10442243 | 21 | C | BACLOFEN. | BACLOFEN | 1 | Unknown | U | 0 | ||||||||||
| 104422433 | 10442243 | 22 | C | TEMAZEPAM. | TEMAZEPAM | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 104422433 | 10442243 | 1 | Multiple sclerosis |
| 104422433 | 10442243 | 3 | Product used for unknown indication |
| 104422433 | 10442243 | 4 | Product used for unknown indication |
| 104422433 | 10442243 | 5 | Product used for unknown indication |
| 104422433 | 10442243 | 6 | Product used for unknown indication |
| 104422433 | 10442243 | 7 | Product used for unknown indication |
| 104422433 | 10442243 | 8 | Product used for unknown indication |
| 104422433 | 10442243 | 9 | Product used for unknown indication |
| 104422433 | 10442243 | 10 | Product used for unknown indication |
| 104422433 | 10442243 | 11 | Product used for unknown indication |
| 104422433 | 10442243 | 12 | Product used for unknown indication |
| 104422433 | 10442243 | 13 | Product used for unknown indication |
| 104422433 | 10442243 | 14 | Product used for unknown indication |
| 104422433 | 10442243 | 15 | Product used for unknown indication |
| 104422433 | 10442243 | 16 | Product used for unknown indication |
| 104422433 | 10442243 | 17 | Product used for unknown indication |
| 104422433 | 10442243 | 18 | Product used for unknown indication |
| 104422433 | 10442243 | 19 | Product used for unknown indication |
| 104422433 | 10442243 | 20 | Product used for unknown indication |
| 104422433 | 10442243 | 21 | Product used for unknown indication |
| 104422433 | 10442243 | 22 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 104422433 | 10442243 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 104422433 | 10442243 | Abdominal pain | |
| 104422433 | 10442243 | Asthenia | |
| 104422433 | 10442243 | Balance disorder | |
| 104422433 | 10442243 | Central nervous system lesion | |
| 104422433 | 10442243 | Chest pain | |
| 104422433 | 10442243 | Constipation | |
| 104422433 | 10442243 | Coordination abnormal | |
| 104422433 | 10442243 | Dyspnoea | |
| 104422433 | 10442243 | Dysuria | |
| 104422433 | 10442243 | Eye pain | |
| 104422433 | 10442243 | Fatigue | |
| 104422433 | 10442243 | Gait disturbance | |
| 104422433 | 10442243 | Headache | |
| 104422433 | 10442243 | Hypoaesthesia | |
| 104422433 | 10442243 | Multiple sclerosis relapse | |
| 104422433 | 10442243 | Muscle spasticity | |
| 104422433 | 10442243 | Musculoskeletal chest pain | |
| 104422433 | 10442243 | Nausea | |
| 104422433 | 10442243 | Pain | |
| 104422433 | 10442243 | Polydipsia | |
| 104422433 | 10442243 | Sensory loss | |
| 104422433 | 10442243 | Sleep disorder | |
| 104422433 | 10442243 | Temperature intolerance | |
| 104422433 | 10442243 | Upper motor neurone lesion | |
| 104422433 | 10442243 | Vibration test abnormal | |
| 104422433 | 10442243 | Vision blurred |
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 |
|---|---|---|---|---|---|---|
| 104422433 | 10442243 | 1 | 2010 | 201403 | 0 | |
| 104422433 | 10442243 | 2 | 20141017 | 0 |