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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124632502 | 12463250 | 2 | F | 20160507 | 20160629 | 20160614 | 20160714 | EXP | US-CIPLA LTD.-2016US06550 | CIPLA | 0.00 | Y | 0.00000 | 20160714 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124632502 | 12463250 | 1 | PS | GABAPENTIN. | GABAPENTIN | 1 | Oral | UNK | N | U | 90705 | CAPSULE | |||||||
| 124632502 | 12463250 | 2 | SS | GABAPENTIN. | GABAPENTIN | 1 | Oral | UNK | N | U | 90705 | CAPSULE | |||||||
| 124632502 | 12463250 | 3 | SS | GABAPENTIN. | GABAPENTIN | 1 | Oral | 600 MG PER DAY (300 MG IN THE MORNING AND 300 MG IN THE EVENING) | N | U | 90705 | 600 | MG | CAPSULE | |||||
| 124632502 | 12463250 | 4 | SS | GABAPENTIN. | GABAPENTIN | 1 | Oral | 500 MG, PER DAY (200 MG IN THE MORNING AND 300 MG) | N | U | 90705 | 500 | MG | CAPSULE | |||||
| 124632502 | 12463250 | 5 | SS | GABAPENTIN. | GABAPENTIN | 1 | Oral | 400 MG, PER DAY (200MG IN THE MORNING AND 200MG IN THE NIGHT) | N | U | 90705 | 400 | MG | CAPSULE | |||||
| 124632502 | 12463250 | 6 | SS | GABAPENTIN. | GABAPENTIN | 1 | Oral | 300 MG, PER DAY (100MG IN THE MORNING AND 200MG IN THE NIGHT) | N | U | 90705 | 300 | MG | CAPSULE | |||||
| 124632502 | 12463250 | 7 | SS | GABAPENTIN. | GABAPENTIN | 1 | Oral | 200 MG, PER DAY (100MG IN THE MORNING AND 100MG IN THE NIGHT) | N | U | 90705 | 200 | MG | CAPSULE | |||||
| 124632502 | 12463250 | 8 | C | DIOVAN | VALSARTAN | 1 | Unknown | 160 MG, PER DAY | U | U | 0 | 160 | MG | ||||||
| 124632502 | 12463250 | 9 | C | DIOVAN | VALSARTAN | 1 | Unknown | 120 MG/DAILY | U | U | 0 | 120 | MG | ||||||
| 124632502 | 12463250 | 10 | C | TRILEPTAL | OXCARBAZEPINE | 1 | Unknown | 200 MG, QD | U | U | 0 | 200 | MG | ||||||
| 124632502 | 12463250 | 11 | C | CLOZAPINE. | CLOZAPINE | 1 | Unknown | 3-4 MG, DAILY | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124632502 | 12463250 | 1 | Neuralgia |
| 124632502 | 12463250 | 8 | Hypertension |
| 124632502 | 12463250 | 10 | Affective disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124632502 | 12463250 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124632502 | 12463250 | Aggression | |
| 124632502 | 12463250 | Agitation | |
| 124632502 | 12463250 | Anger | |
| 124632502 | 12463250 | Anxiety | |
| 124632502 | 12463250 | Bipolar I disorder | |
| 124632502 | 12463250 | Disturbance in attention | |
| 124632502 | 12463250 | Feeling jittery | |
| 124632502 | 12463250 | Headache | |
| 124632502 | 12463250 | Impulsive behaviour | |
| 124632502 | 12463250 | Irritability | |
| 124632502 | 12463250 | Sedation | |
| 124632502 | 12463250 | Thinking abnormal |
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 |
|---|---|---|---|---|---|---|
| 124632502 | 12463250 | 1 | 201601 | 0 | ||
| 124632502 | 12463250 | 3 | 20160419 | 0 | ||
| 124632502 | 12463250 | 5 | 20160510 | 0 | ||
| 124632502 | 12463250 | 6 | 20160516 | 0 | ||
| 124632502 | 12463250 | 7 | 20160524 | 0 |