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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112726498 | 11272649 | 8 | F | 20140506 | 20160822 | 20150715 | 20160829 | PER | PHHY2014US072268 | NOVARTIS | 43.99 | YR | F | Y | 0.00000 | 20160829 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112726498 | 11272649 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | UNK UNK, QD | 22527 | CAPSULE | QD | ||||||||
| 112726498 | 11272649 | 2 | C | LYRICA | PREGABALIN | 1 | Unknown | U | 0 | ||||||||||
| 112726498 | 11272649 | 3 | C | PROMETHEGAN | PROMETHAZINE HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 112726498 | 11272649 | 4 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | UNK | Y | 0 | |||||||||
| 112726498 | 11272649 | 5 | C | MARIJUANA | CANNABIS SATIVA SUBSP. INDICA TOP | 1 | Unknown | U | 0 | ||||||||||
| 112726498 | 11272649 | 6 | C | MARIJUANA | CANNABIS SATIVA SUBSP. INDICA TOP | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 112726498 | 11272649 | 1 | Multiple sclerosis |
| 112726498 | 11272649 | 2 | Pain |
| 112726498 | 11272649 | 3 | Product used for unknown indication |
| 112726498 | 11272649 | 4 | Product used for unknown indication |
| 112726498 | 11272649 | 5 | Muscle spasticity |
| 112726498 | 11272649 | 6 | Restless legs syndrome |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 112726498 | 11272649 | Acne | |
| 112726498 | 11272649 | Alanine aminotransferase increased | |
| 112726498 | 11272649 | Aspartate aminotransferase increased | |
| 112726498 | 11272649 | Blood alkaline phosphatase increased | |
| 112726498 | 11272649 | Blood creatinine decreased | |
| 112726498 | 11272649 | Candida infection | |
| 112726498 | 11272649 | Dermatitis | |
| 112726498 | 11272649 | Fatigue | |
| 112726498 | 11272649 | Fungal skin infection | |
| 112726498 | 11272649 | Gait disturbance | |
| 112726498 | 11272649 | Gastroenteritis | |
| 112726498 | 11272649 | Headache | |
| 112726498 | 11272649 | Herpes zoster | |
| 112726498 | 11272649 | Hyperreflexia | |
| 112726498 | 11272649 | Hypoaesthesia | |
| 112726498 | 11272649 | Intervertebral disc protrusion | |
| 112726498 | 11272649 | Laceration | |
| 112726498 | 11272649 | Liver function test increased | |
| 112726498 | 11272649 | Lymphocyte count decreased | |
| 112726498 | 11272649 | Migraine | |
| 112726498 | 11272649 | Multiple sclerosis relapse | |
| 112726498 | 11272649 | Muscular weakness | |
| 112726498 | 11272649 | Nausea | |
| 112726498 | 11272649 | Oedema peripheral | |
| 112726498 | 11272649 | Pain in extremity | |
| 112726498 | 11272649 | Paraesthesia | |
| 112726498 | 11272649 | Rash | |
| 112726498 | 11272649 | Sleep apnoea syndrome | |
| 112726498 | 11272649 | Tooth infection | |
| 112726498 | 11272649 | Upper respiratory tract infection | |
| 112726498 | 11272649 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 112726498 | 11272649 | 1 | 20140506 | 0 | ||
| 112726498 | 11272649 | 2 | 20140801 | 0 | ||
| 112726498 | 11272649 | 3 | 20141231 | 0 | ||
| 112726498 | 11272649 | 4 | 20150520 | 20150528 | 0 | |
| 112726498 | 11272649 | 5 | 20140915 | 0 |