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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124498602 | 12449860 | 2 | F | 2010 | 20160603 | 20160609 | 20160830 | PER | US-JNJFOC-20160503994 | JANSSEN | 0.00 | T | M | Y | 0.00000 | 20160830 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124498602 | 12449860 | 1 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | 1 | MG | TABLETS | ||||||
| 124498602 | 12449860 | 2 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | .5 | MG | TABLETS | ||||||
| 124498602 | 12449860 | 3 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | 1 | MG | TABLETS | ||||||
| 124498602 | 12449860 | 4 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | .5 | MG | TABLETS | ||||||
| 124498602 | 12449860 | 5 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | 1 | MG | TABLETS | ||||||
| 124498602 | 12449860 | 6 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | 1 | MG | TABLETS | ||||||
| 124498602 | 12449860 | 7 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | .5 | MG | TABLETS | ||||||
| 124498602 | 12449860 | 8 | SS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 0 | 1 | MG | TABLETS | ||||||
| 124498602 | 12449860 | 9 | PS | RISPERDAL | RISPERIDONE | 1 | Oral | U | U | 20272 | 1 | MG | TABLETS | ||||||
| 124498602 | 12449860 | 10 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | U | U | 0 | 1 | MG | TABLETS | ||||||
| 124498602 | 12449860 | 11 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | U | U | 0 | 1 | MG | TABLETS | ||||||
| 124498602 | 12449860 | 12 | SS | RISPERIDONE. | RISPERIDONE | 1 | Oral | U | U | 20272 | 1 | MG | TABLETS | ||||||
| 124498602 | 12449860 | 13 | SS | RISPERIDONE. | RISPERIDONE | 1 | Unknown | U | 0 | 1 | MG | TABLETS | |||||||
| 124498602 | 12449860 | 14 | SS | RISPERIDONE. | RISPERIDONE | 1 | Unknown | U | 0 | TABLETS | |||||||||
| 124498602 | 12449860 | 15 | SS | RISPERIDONE. | RISPERIDONE | 1 | Unknown | U | 0 | TABLETS | |||||||||
| 124498602 | 12449860 | 16 | SS | RISPERIDONE. | RISPERIDONE | 1 | Unknown | U | 0 | 1 | MG | TABLETS | |||||||
| 124498602 | 12449860 | 17 | SS | RISPERIDONE. | RISPERIDONE | 1 | Unknown | U | 0 | TABLETS | |||||||||
| 124498602 | 12449860 | 18 | SS | RISPERIDONE. | RISPERIDONE | 1 | Unknown | U | 0 | TABLETS | |||||||||
| 124498602 | 12449860 | 19 | SS | RISPERIDONE. | RISPERIDONE | 1 | Unknown | U | 0 | 1 | MG | TABLETS | |||||||
| 124498602 | 12449860 | 20 | SS | RISPERIDONE. | RISPERIDONE | 1 | Unknown | U | 0 | TABLETS | |||||||||
| 124498602 | 12449860 | 21 | SS | RISPERIDONE. | RISPERIDONE | 1 | Unknown | U | 0 | TABLETS |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124498602 | 12449860 | 1 | Post-traumatic stress disorder |
| 124498602 | 12449860 | 2 | Post-traumatic stress disorder |
| 124498602 | 12449860 | 3 | Post-traumatic stress disorder |
| 124498602 | 12449860 | 4 | Conduct disorder |
| 124498602 | 12449860 | 5 | Conduct disorder |
| 124498602 | 12449860 | 6 | Conduct disorder |
| 124498602 | 12449860 | 7 | Bipolar disorder |
| 124498602 | 12449860 | 8 | Bipolar disorder |
| 124498602 | 12449860 | 9 | Bipolar disorder |
| 124498602 | 12449860 | 10 | Post-traumatic stress disorder |
| 124498602 | 12449860 | 11 | Conduct disorder |
| 124498602 | 12449860 | 12 | Bipolar disorder |
| 124498602 | 12449860 | 13 | Post-traumatic stress disorder |
| 124498602 | 12449860 | 14 | Post-traumatic stress disorder |
| 124498602 | 12449860 | 15 | Post-traumatic stress disorder |
| 124498602 | 12449860 | 16 | Conduct disorder |
| 124498602 | 12449860 | 17 | Conduct disorder |
| 124498602 | 12449860 | 18 | Conduct disorder |
| 124498602 | 12449860 | 19 | Bipolar disorder |
| 124498602 | 12449860 | 20 | Bipolar disorder |
| 124498602 | 12449860 | 21 | Bipolar disorder |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124498602 | 12449860 | Emotional distress | |
| 124498602 | 12449860 | Gynaecomastia | |
| 124498602 | 12449860 | 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 |
|---|---|---|---|---|---|---|
| 124498602 | 12449860 | 1 | 20080429 | 20080626 | 0 | |
| 124498602 | 12449860 | 2 | 20080407 | 0 | ||
| 124498602 | 12449860 | 3 | 20091018 | 0 | ||
| 124498602 | 12449860 | 4 | 20080407 | 0 | ||
| 124498602 | 12449860 | 5 | 20091018 | 0 | ||
| 124498602 | 12449860 | 6 | 20080429 | 20080626 | 0 | |
| 124498602 | 12449860 | 7 | 20080407 | 0 | ||
| 124498602 | 12449860 | 8 | 20091018 | 0 | ||
| 124498602 | 12449860 | 9 | 20080429 | 20080626 | 0 | |
| 124498602 | 12449860 | 10 | 20080724 | 20090617 | 0 | |
| 124498602 | 12449860 | 11 | 20080724 | 20090617 | 0 | |
| 124498602 | 12449860 | 12 | 20080724 | 20090617 | 0 | |
| 124498602 | 12449860 | 13 | 20091118 | 20100707 | 0 | |
| 124498602 | 12449860 | 14 | 20100811 | 20101130 | 0 | |
| 124498602 | 12449860 | 15 | 20110527 | 20110720 | 0 | |
| 124498602 | 12449860 | 16 | 20091118 | 20100707 | 0 | |
| 124498602 | 12449860 | 17 | 20100811 | 20101130 | 0 | |
| 124498602 | 12449860 | 18 | 20110527 | 20110720 | 0 | |
| 124498602 | 12449860 | 19 | 20091118 | 20100707 | 0 | |
| 124498602 | 12449860 | 20 | 20110527 | 20110720 | 0 | |
| 124498602 | 12449860 | 21 | 20100811 | 20101130 | 0 |