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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113806263 | 11380626 | 3 | F | 200810 | 20160720 | 20150814 | 20160804 | EXP | US-JNJFOC-20150722752 | JANSSEN | 35.28 | YR | A | M | Y | 61.69000 | KG | 20160804 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113806263 | 11380626 | 1 | SS | LEVAQUIN | LEVOFLOXACIN | 1 | Oral | U | U | 0 | 500 | MG | UNSPECIFIED | ||||||
| 113806263 | 11380626 | 2 | SS | LEVAQUIN | LEVOFLOXACIN | 1 | Oral | U | U | 0 | 750 | MG | UNSPECIFIED | ||||||
| 113806263 | 11380626 | 3 | SS | LEVAQUIN | LEVOFLOXACIN | 1 | Oral | U | U | 0 | 500 | MG | UNSPECIFIED | ||||||
| 113806263 | 11380626 | 4 | PS | LEVAQUIN | LEVOFLOXACIN | 1 | Oral | U | U | 20634 | 750 | MG | UNSPECIFIED | ||||||
| 113806263 | 11380626 | 5 | SS | AVELOX | MOXIFLOXACIN HYDROCHLORIDE | 1 | Oral | U | 0 | 400 | MG | UNSPECIFIED | |||||||
| 113806263 | 11380626 | 6 | SS | AVELOX | MOXIFLOXACIN HYDROCHLORIDE | 1 | Oral | U | 0 | 400 | MG | UNSPECIFIED | |||||||
| 113806263 | 11380626 | 7 | SS | CIPRO | CIPROFLOXACIN HYDROCHLORIDE | 1 | Oral | U | 0 | UNSPECIFIED | |||||||||
| 113806263 | 11380626 | 8 | SS | MEDROL | METHYLPREDNISOLONE | 1 | Oral | U | 0 | UNSPECIFIED | |||||||||
| 113806263 | 11380626 | 9 | SS | MEDROL | METHYLPREDNISOLONE | 1 | Oral | U | 0 | UNSPECIFIED | |||||||||
| 113806263 | 11380626 | 10 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | U | 0 | 60 | MG | UNSPECIFIED | |||||||
| 113806263 | 11380626 | 11 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | U | 0 | 60 | MG | UNSPECIFIED | |||||||
| 113806263 | 11380626 | 12 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 113806263 | 11380626 | 13 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 113806263 | 11380626 | 14 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 113806263 | 11380626 | 15 | C | MODAFINIL. | MODAFINIL | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 113806263 | 11380626 | 16 | C | MODAFINIL. | MODAFINIL | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 113806263 | 11380626 | 17 | C | MODAFINIL. | MODAFINIL | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 113806263 | 11380626 | 18 | C | MODAFINIL. | MODAFINIL | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 113806263 | 11380626 | 19 | C | MODAFINIL. | MODAFINIL | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 113806263 | 11380626 | 20 | C | MODAFINIL. | MODAFINIL | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 113806263 | 11380626 | 21 | C | MODAFINIL. | MODAFINIL | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 113806263 | 11380626 | 22 | C | MODAFINIL. | MODAFINIL | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 113806263 | 11380626 | 23 | C | BACTRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113806263 | 11380626 | 1 | Lower respiratory tract infection |
| 113806263 | 11380626 | 2 | Lower respiratory tract infection |
| 113806263 | 11380626 | 3 | Nasopharyngitis |
| 113806263 | 11380626 | 4 | Nasopharyngitis |
| 113806263 | 11380626 | 5 | Dysphagia |
| 113806263 | 11380626 | 6 | Oropharyngeal pain |
| 113806263 | 11380626 | 7 | Oropharyngeal pain |
| 113806263 | 11380626 | 8 | Oropharyngeal pain |
| 113806263 | 11380626 | 9 | Pharyngeal oedema |
| 113806263 | 11380626 | 10 | Oropharyngeal pain |
| 113806263 | 11380626 | 11 | Pharyngeal oedema |
| 113806263 | 11380626 | 12 | Attention deficit/hyperactivity disorder |
| 113806263 | 11380626 | 13 | Attention deficit/hyperactivity disorder |
| 113806263 | 11380626 | 14 | Attention deficit/hyperactivity disorder |
| 113806263 | 11380626 | 15 | Asthenia |
| 113806263 | 11380626 | 16 | Asthenia |
| 113806263 | 11380626 | 17 | Asthenia |
| 113806263 | 11380626 | 18 | Asthenia |
| 113806263 | 11380626 | 19 | Somnolence |
| 113806263 | 11380626 | 20 | Somnolence |
| 113806263 | 11380626 | 21 | Somnolence |
| 113806263 | 11380626 | 22 | Somnolence |
| 113806263 | 11380626 | 23 | Oropharyngeal pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113806263 | 11380626 | HO |
| 113806263 | 11380626 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113806263 | 11380626 | Mitochondrial cytopathy | |
| 113806263 | 11380626 | Musculoskeletal injury | |
| 113806263 | 11380626 | Neuropathy peripheral |
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 |
|---|---|---|---|---|---|---|
| 113806263 | 11380626 | 1 | 20080925 | 20081006 | 0 | |
| 113806263 | 11380626 | 2 | 20080915 | 20080925 | 0 | |
| 113806263 | 11380626 | 3 | 20080925 | 20081006 | 0 | |
| 113806263 | 11380626 | 4 | 20080915 | 20080925 | 0 | |
| 113806263 | 11380626 | 5 | 20081006 | 20081117 | 0 | |
| 113806263 | 11380626 | 6 | 20081006 | 20081117 | 0 | |
| 113806263 | 11380626 | 7 | 20080924 | 0 | ||
| 113806263 | 11380626 | 8 | 20080915 | 20081006 | 0 | |
| 113806263 | 11380626 | 9 | 20080915 | 20081006 | 0 | |
| 113806263 | 11380626 | 10 | 20080915 | 20081006 | 0 | |
| 113806263 | 11380626 | 11 | 20080915 | 20081006 | 0 | |
| 113806263 | 11380626 | 12 | 2008 | 0 | ||
| 113806263 | 11380626 | 13 | 2009 | 0 | ||
| 113806263 | 11380626 | 14 | 2011 | 0 | ||
| 113806263 | 11380626 | 15 | 2010 | 0 | ||
| 113806263 | 11380626 | 16 | 2011 | 0 | ||
| 113806263 | 11380626 | 17 | 2009 | 0 | ||
| 113806263 | 11380626 | 18 | 2008 | 0 | ||
| 113806263 | 11380626 | 19 | 2010 | 0 | ||
| 113806263 | 11380626 | 20 | 2009 | 0 | ||
| 113806263 | 11380626 | 21 | 2008 | 0 | ||
| 113806263 | 11380626 | 22 | 2011 | 0 | ||
| 113806263 | 11380626 | 23 | 200809 | 0 |