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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126079301 | 12607930 | 1 | I | 20160418 | 20160725 | 20160729 | 20160729 | EXP | GB-MHRA-EYC 00142672 | PHHY2016GB102410 | SANDOZ | 38.00 | YR | F | Y | 68.00000 | KG | 20160729 | OT | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126079301 | 12607930 | 1 | PS | TOPIRAMATE. | TOPIRAMATE | 1 | Oral | 50 MG, BID | 400 | MG | Y | U | 79206 | 50 | MG | BID | |||
| 126079301 | 12607930 | 2 | C | IBUPROFEN. | IBUPROFEN | 1 | Unknown | U | 0 | ||||||||||
| 126079301 | 12607930 | 3 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Unknown | U | 0 | ||||||||||
| 126079301 | 12607930 | 4 | C | SUMATRIPTAN. | SUMATRIPTAN | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126079301 | 12607930 | 1 | Cluster headache |
| 126079301 | 12607930 | 2 | Product used for unknown indication |
| 126079301 | 12607930 | 3 | Product used for unknown indication |
| 126079301 | 12607930 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126079301 | 12607930 | OT |
| 126079301 | 12607930 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126079301 | 12607930 | Abulia | |
| 126079301 | 12607930 | Anger | |
| 126079301 | 12607930 | Anxiety | |
| 126079301 | 12607930 | Blepharospasm | |
| 126079301 | 12607930 | Cognitive disorder | |
| 126079301 | 12607930 | Confusional state | |
| 126079301 | 12607930 | Cough | |
| 126079301 | 12607930 | Decreased appetite | |
| 126079301 | 12607930 | Disturbance in attention | |
| 126079301 | 12607930 | Dysgeusia | |
| 126079301 | 12607930 | Eye pain | |
| 126079301 | 12607930 | Fatigue | |
| 126079301 | 12607930 | Feeling abnormal | |
| 126079301 | 12607930 | Memory impairment | |
| 126079301 | 12607930 | Mood swings | |
| 126079301 | 12607930 | Paraesthesia | |
| 126079301 | 12607930 | Tearfulness |
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 |
|---|---|---|---|---|---|---|
| 126079301 | 12607930 | 1 | 20160414 | 20160525 | 0 |