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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123948732 | 12394873 | 2 | F | 2015 | 20160708 | 20160523 | 20160713 | EXP | GB-JNJFOC-20160516218 | JANSSEN | 37.00 | YR | A | M | Y | 0.00000 | 20160713 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123948732 | 12394873 | 1 | PS | TOPIRAMATE. | TOPIRAMATE | 1 | Unknown | U | U | UNKNOWN | 20505 | 25 | MG | UNSPECIFIED | QD | ||||
| 123948732 | 12394873 | 2 | SS | KEPPRA | LEVETIRACETAM | 1 | Oral | LW50150348, G508399 | 0 | 1500 | DF | FILM COATED TABLET | BID | ||||||
| 123948732 | 12394873 | 3 | C | CETIRIZINE HYDROCHLORIDE. | CETIRIZINE HYDROCHLORIDE | 1 | Unknown | 0 | 10 | MG | UNSPECIFIED | QD | |||||||
| 123948732 | 12394873 | 4 | C | HYDROCORTISONE. | HYDROCORTISONE | 1 | Unknown | 0 | 10 | MG | UNSPECIFIED | TID | |||||||
| 123948732 | 12394873 | 5 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 123948732 | 12394873 | 6 | C | VITAMIN C | ASCORBIC ACID | 1 | Unknown | 0 | 1000 | MG | UNSPECIFIED | ||||||||
| 123948732 | 12394873 | 7 | C | LORAZEPAM. | LORAZEPAM | 1 | Unknown | 0 | 1 | MG | UNSPECIFIED | QD | |||||||
| 123948732 | 12394873 | 8 | C | BUPRANOLOL | BUPRANOLOL | 1 | Unknown | 0 | 40 | MG | UNSPECIFIED | QD | |||||||
| 123948732 | 12394873 | 9 | C | EFAVIRENZ W/EMTRICITABINE/TENOFOVIR DISOPROXI | EFAVIRENZEMTRICITABINETENOFOVIR DISOPROXIL FUMARATE | 1 | Unknown | EFAVIRENZ- 600MG, EMTRICITABINE-200MG AND TENOFOVIR- 245MG | 0 | UNSPECIFIED | |||||||||
| 123948732 | 12394873 | 10 | C | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | Unknown | 0 | 30 | MG | UNSPECIFIED | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123948732 | 12394873 | 1 | Seizure |
| 123948732 | 12394873 | 2 | Seizure |
| 123948732 | 12394873 | 3 | Product used for unknown indication |
| 123948732 | 12394873 | 4 | Product used for unknown indication |
| 123948732 | 12394873 | 5 | Product used for unknown indication |
| 123948732 | 12394873 | 6 | Product used for unknown indication |
| 123948732 | 12394873 | 7 | Product used for unknown indication |
| 123948732 | 12394873 | 8 | Product used for unknown indication |
| 123948732 | 12394873 | 9 | Product used for unknown indication |
| 123948732 | 12394873 | 10 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123948732 | 12394873 | HO |
| 123948732 | 12394873 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123948732 | 12394873 | Drug ineffective | |
| 123948732 | 12394873 | Seizure | |
| 123948732 | 12394873 | Somnolence | |
| 123948732 | 12394873 | Unresponsive to stimuli |
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 |
|---|---|---|---|---|---|---|
| 123948732 | 12394873 | 2 | 2008 | 0 |