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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126784991 | 12678499 | 1 | I | 20160223 | 20160823 | 20160823 | PER | US-PRESTIUM-2016RN000262 | RENAISSANCE | 5.00 | YR | M | Y | 0.00000 | 20160823 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126784991 | 12678499 | 1 | PS | LITHIUM CARBONATE. | LITHIUM CARBONATE | 1 | Unknown | Y | 76243 | ||||||||||
| 126784991 | 12678499 | 2 | SS | RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 1 | Unknown | 0 | |||||||||||
| 126784991 | 12678499 | 3 | SS | SYMMETREL | AMANTADINE HYDROCHLORIDE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126784991 | 12678499 | 1 | Bipolar disorder |
| 126784991 | 12678499 | 2 | Product used for unknown indication |
| 126784991 | 12678499 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126784991 | 12678499 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126784991 | 12678499 | Aggression | |
| 126784991 | 12678499 | Agitation | |
| 126784991 | 12678499 | Antipsychotic drug level above therapeutic | |
| 126784991 | 12678499 | Ataxia | |
| 126784991 | 12678499 | Atrioventricular block first degree | |
| 126784991 | 12678499 | Blood creatinine increased | |
| 126784991 | 12678499 | Blood thyroid stimulating hormone increased | |
| 126784991 | 12678499 | Diarrhoea | |
| 126784991 | 12678499 | Disorientation | |
| 126784991 | 12678499 | Dysarthria | |
| 126784991 | 12678499 | Electrocardiogram QRS complex prolonged | |
| 126784991 | 12678499 | Electrocardiogram QT prolonged | |
| 126784991 | 12678499 | Electrocardiogram ST segment depression | |
| 126784991 | 12678499 | Electrocardiogram T wave amplitude decreased | |
| 126784991 | 12678499 | Electrocardiogram T wave inversion | |
| 126784991 | 12678499 | Electrolyte imbalance | |
| 126784991 | 12678499 | Fluid intake reduced | |
| 126784991 | 12678499 | Gait disturbance | |
| 126784991 | 12678499 | Hypotonia | |
| 126784991 | 12678499 | Nodal rhythm | |
| 126784991 | 12678499 | Pyrexia | |
| 126784991 | 12678499 | Sinus node dysfunction | |
| 126784991 | 12678499 | Toxicity to various agents | |
| 126784991 | 12678499 | Tremor | |
| 126784991 | 12678499 | Vomiting |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |