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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123904545 | 12390454 | 5 | F | 201508 | 20160823 | 20160520 | 20160901 | EXP | US-JNJFOC-20160514540 | JANSSEN | 44.86 | YR | A | M | Y | 0.00000 | 20160901 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123904545 | 12390454 | 1 | SS | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | Intramuscular | Y | Y | UNKNOWN;UNKNOWN;UNKNOWN +MORE | 0 | 156 | MG | INJECTION | |||||
| 123904545 | 12390454 | 2 | SS | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | Intramuscular | Y | Y | UNKNOWN;UNKNOWN;UNKNOWN +MORE | 0 | 156 | MG | INJECTION | |||||
| 123904545 | 12390454 | 3 | SS | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | Intramuscular | Y | Y | UNKNOWN;UNKNOWN;UNKNOWN +MORE | 0 | INJECTION | |||||||
| 123904545 | 12390454 | 4 | SS | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | Intramuscular | Y | Y | UNKNOWN;UNKNOWN;UNKNOWN +MORE | 0 | 156 | MG | INJECTION | |||||
| 123904545 | 12390454 | 5 | SS | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | Intramuscular | Y | Y | UNKNOWN;UNKNOWN;UNKNOWN +MORE | 0 | 234 | MG | INJECTION | |||||
| 123904545 | 12390454 | 6 | SS | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | Intramuscular | Y | Y | UNKNOWN;UNKNOWN;UNKNOWN +MORE | 0 | 156 | MG | INJECTION | |||||
| 123904545 | 12390454 | 7 | SS | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | Intramuscular | Y | Y | UNKNOWN;UNKNOWN;UNKNOWN +MORE | 0 | 156 | MG | INJECTION | |||||
| 123904545 | 12390454 | 8 | SS | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | Intramuscular | Y | Y | UNKNOWN;UNKNOWN;UNKNOWN +MORE | 0 | 234 | MG | INJECTION | |||||
| 123904545 | 12390454 | 9 | SS | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | Intramuscular | Y | Y | UNKNOWN;UNKNOWN;UNKNOWN +MORE | 0 | 156 | MG | INJECTION | |||||
| 123904545 | 12390454 | 10 | PS | INVEGA SUSTENNA | PALIPERIDONE PALMITATE | 1 | Intramuscular | Y | Y | UNKNOWN;UNKNOWN;UNKNOWN +MORE | 22264 | INJECTION | |||||||
| 123904545 | 12390454 | 11 | SS | OLANZAPINE. | OLANZAPINE | 1 | Oral | NIGHTLY | 0 | 15 | MG | TABLET | QD | ||||||
| 123904545 | 12390454 | 12 | SS | OLANZAPINE. | OLANZAPINE | 1 | Oral | NIGHTLY | 0 | 15 | MG | TABLET | QD | ||||||
| 123904545 | 12390454 | 13 | SS | OLANZAPINE. | OLANZAPINE | 1 | Oral | NIGHTLY | 0 | 15 | MG | TABLET | QD | ||||||
| 123904545 | 12390454 | 14 | C | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | Unknown | 0 | 100 | MG | UNSPECIFIED | ||||||||
| 123904545 | 12390454 | 15 | C | LORAZEPAM. | LORAZEPAM | 1 | Oral | AS NEEDED | 0 | .5 | MG | TABLET | |||||||
| 123904545 | 12390454 | 16 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | Oral | 0 | .25 | MG | UNSPECIFIED | QD | |||||||
| 123904545 | 12390454 | 17 | C | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Unknown | 100-150 MG | 0 | UNSPECIFIED | |||||||||
| 123904545 | 12390454 | 18 | C | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Unknown | 100-150 MG | 0 | UNSPECIFIED | |||||||||
| 123904545 | 12390454 | 19 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 123904545 | 12390454 | 20 | C | BENZOTROPINE | BENZTROPINE | 1 | Unknown | USED IN 2012 TOO??0.5 MG TWICE A DAY AS NECESSARY | 0 | 1 | MG | UNSPECIFIED | BID | ||||||
| 123904545 | 12390454 | 21 | C | CLONAZEPAM. | CLONAZEPAM | 1 | Unknown | 0 | .5 | MG | UNSPECIFIED | BID | |||||||
| 123904545 | 12390454 | 22 | C | CLONAZEPAM. | CLONAZEPAM | 1 | Unknown | 0 | .5 | MG | UNSPECIFIED | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123904545 | 12390454 | 1 | Psychotic disorder |
| 123904545 | 12390454 | 2 | Psychotic disorder |
| 123904545 | 12390454 | 3 | Psychotic disorder |
| 123904545 | 12390454 | 4 | Psychotic disorder |
| 123904545 | 12390454 | 5 | Psychotic disorder |
| 123904545 | 12390454 | 6 | Bipolar I disorder |
| 123904545 | 12390454 | 7 | Bipolar I disorder |
| 123904545 | 12390454 | 8 | Bipolar I disorder |
| 123904545 | 12390454 | 9 | Bipolar I disorder |
| 123904545 | 12390454 | 10 | Bipolar I disorder |
| 123904545 | 12390454 | 11 | Psychotic disorder |
| 123904545 | 12390454 | 12 | Panic disorder |
| 123904545 | 12390454 | 13 | Anxiety |
| 123904545 | 12390454 | 14 | Depression |
| 123904545 | 12390454 | 15 | Anxiety |
| 123904545 | 12390454 | 16 | Thyroid disorder |
| 123904545 | 12390454 | 17 | Anxiety |
| 123904545 | 12390454 | 18 | Depression |
| 123904545 | 12390454 | 19 | Product used for unknown indication |
| 123904545 | 12390454 | 20 | Akathisia |
| 123904545 | 12390454 | 21 | Anxiety |
| 123904545 | 12390454 | 22 | Akathisia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123904545 | 12390454 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123904545 | 12390454 | Akathisia | |
| 123904545 | 12390454 | Anxiety | |
| 123904545 | 12390454 | Depression | |
| 123904545 | 12390454 | Dyspnoea | |
| 123904545 | 12390454 | Mania | |
| 123904545 | 12390454 | Nervousness | Nervousness |
| 123904545 | 12390454 | Stress | |
| 123904545 | 12390454 | Weight decreased | |
| 123904545 | 12390454 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 123904545 | 12390454 | 1 | 20150826 | 0 | ||
| 123904545 | 12390454 | 2 | 201603 | 20160606 | 0 | |
| 123904545 | 12390454 | 3 | 201506 | 0 | ||
| 123904545 | 12390454 | 4 | 201608 | 0 | ||
| 123904545 | 12390454 | 5 | 201508 | 201603 | 0 | |
| 123904545 | 12390454 | 6 | 20150826 | 0 | ||
| 123904545 | 12390454 | 7 | 201608 | 0 | ||
| 123904545 | 12390454 | 8 | 201508 | 201603 | 0 | |
| 123904545 | 12390454 | 9 | 201603 | 20160606 | 0 | |
| 123904545 | 12390454 | 10 | 201506 | 0 | ||
| 123904545 | 12390454 | 11 | 20150616 | 0 | ||
| 123904545 | 12390454 | 12 | 20150616 | 0 | ||
| 123904545 | 12390454 | 13 | 20150616 | 0 | ||
| 123904545 | 12390454 | 14 | 201604 | 0 | ||
| 123904545 | 12390454 | 20 | 20160121 | 0 | ||
| 123904545 | 12390454 | 21 | 20150616 | 0 | ||
| 123904545 | 12390454 | 22 | 20150616 | 0 |