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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113065827 | 11306582 | 7 | F | 2015 | 20160804 | 20150723 | 20160810 | EXP | PHHY2014BR130324 | NOVARTIS | 59.16 | YR | F | Y | 45.00000 | KG | 20160810 | OT | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113065827 | 11306582 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | SC678/SA204/SA892/SC401 | 22527 | .5 | MG | CAPSULE | QD | |||||
| 113065827 | 11306582 | 2 | C | RISEDRONATE | RISEDRONATE SODIUM | 1 | Unknown | 1 DF, UNK | 0 | 1 | DF | TABLET | |||||||
| 113065827 | 11306582 | 3 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Unknown | 5 DRP, UNK | 0 | 5 | GTT | DROPS | |||||||
| 113065827 | 11306582 | 4 | C | ALENDRONATE | ALENDRONATE SODIUM | 1 | Unknown | Y | 0 | ||||||||||
| 113065827 | 11306582 | 5 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113065827 | 11306582 | 1 | Multiple sclerosis |
| 113065827 | 11306582 | 2 | Osteoporosis |
| 113065827 | 11306582 | 3 | Osteoporosis |
| 113065827 | 11306582 | 4 | Osteoporosis |
| 113065827 | 11306582 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113065827 | 11306582 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113065827 | 11306582 | Abdominal discomfort | |
| 113065827 | 11306582 | Arthralgia | |
| 113065827 | 11306582 | Asthenia | |
| 113065827 | 11306582 | Back pain | |
| 113065827 | 11306582 | Balance disorder | |
| 113065827 | 11306582 | Body height decreased | |
| 113065827 | 11306582 | Cataract | |
| 113065827 | 11306582 | Cough | |
| 113065827 | 11306582 | Decreased appetite | |
| 113065827 | 11306582 | Diarrhoea | |
| 113065827 | 11306582 | Dyspepsia | |
| 113065827 | 11306582 | Emotional disorder | |
| 113065827 | 11306582 | Feeling abnormal | |
| 113065827 | 11306582 | Gait disturbance | |
| 113065827 | 11306582 | Headache | |
| 113065827 | 11306582 | Hypoaesthesia | |
| 113065827 | 11306582 | Influenza | |
| 113065827 | 11306582 | Intellectual disability | |
| 113065827 | 11306582 | Malaise | |
| 113065827 | 11306582 | Multiple sclerosis relapse | |
| 113065827 | 11306582 | Muscle spasms | |
| 113065827 | 11306582 | Pain | |
| 113065827 | 11306582 | Pain in extremity | |
| 113065827 | 11306582 | Paraesthesia | |
| 113065827 | 11306582 | Product quality issue | |
| 113065827 | 11306582 | Productive cough | |
| 113065827 | 11306582 | Pulmonary pain | |
| 113065827 | 11306582 | Renal pain | |
| 113065827 | 11306582 | Retching | |
| 113065827 | 11306582 | Rhinorrhoea | |
| 113065827 | 11306582 | Viral infection | |
| 113065827 | 11306582 | Vision blurred | |
| 113065827 | 11306582 | Visual impairment | |
| 113065827 | 11306582 | Weight 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 |
|---|---|---|---|---|---|---|
| 113065827 | 11306582 | 1 | 20140627 | 0 |