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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 108695146 | 10869514 | 6 | F | 201501 | 20160823 | 20150226 | 20160826 | EXP | JP-GLAXOSMITHKLINE-JP2015JPN022427 | GLAXOSMITHKLINE | 31.63 | YR | F | Y | 44.00000 | KG | 20160826 | CN | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 108695146 | 10869514 | 1 | PS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 25 MG, QD | 200 | MG | Y | Y | 20241 | 25 | MG | TABLET | QD | ||
| 108695146 | 10869514 | 2 | SS | LIMAS | LITHIUM CARBONATE | 1 | Oral | 1000 MG, 1D | 40000 | MG | Y | 0 | 1000 | MG | QD | ||||
| 108695146 | 10869514 | 3 | C | MAGMITT | MAGNESIUM OXIDE | 1 | UNK | 0 | |||||||||||
| 108695146 | 10869514 | 4 | C | LAC-B | BIFIDOBACTERIUM SPP. | 1 | UNK | 0 | |||||||||||
| 108695146 | 10869514 | 5 | C | ROHYPNOL | FLUNITRAZEPAM | 1 | 0 | ||||||||||||
| 108695146 | 10869514 | 6 | C | LUNESTA | ESZOPICLONE | 1 | 0 | ||||||||||||
| 108695146 | 10869514 | 7 | C | BROTIZOLAM | BROTIZOLAM | 1 | 0 | ||||||||||||
| 108695146 | 10869514 | 8 | C | ABILIFY | ARIPIPRAZOLE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 108695146 | 10869514 | 1 | Bipolar disorder |
| 108695146 | 10869514 | 2 | Bipolar disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 108695146 | 10869514 | OT |
| 108695146 | 10869514 | LT |
| 108695146 | 10869514 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 108695146 | 10869514 | Conjunctival hyperaemia | |
| 108695146 | 10869514 | Conjunctivitis | |
| 108695146 | 10869514 | Disseminated intravascular coagulation | |
| 108695146 | 10869514 | Drug eruption | Drug eruption |
| 108695146 | 10869514 | Dyslalia | |
| 108695146 | 10869514 | Enanthema | |
| 108695146 | 10869514 | Erythema | Erythema |
| 108695146 | 10869514 | Erythema of eyelid | |
| 108695146 | 10869514 | Eye discharge | |
| 108695146 | 10869514 | Eyelid erosion | |
| 108695146 | 10869514 | Eyelid function disorder | |
| 108695146 | 10869514 | Eyelid oedema | |
| 108695146 | 10869514 | Face oedema | |
| 108695146 | 10869514 | Feeling hot | |
| 108695146 | 10869514 | Fluid intake reduced | |
| 108695146 | 10869514 | Gait disturbance | |
| 108695146 | 10869514 | General physical health deterioration | |
| 108695146 | 10869514 | Headache | |
| 108695146 | 10869514 | Hyperthermia | |
| 108695146 | 10869514 | Lip erosion | |
| 108695146 | 10869514 | Local swelling | |
| 108695146 | 10869514 | Lymphadenopathy | |
| 108695146 | 10869514 | Mouth haemorrhage | Mouth haemorrhage |
| 108695146 | 10869514 | Mumps | |
| 108695146 | 10869514 | Ocular hyperaemia | |
| 108695146 | 10869514 | Oculomucocutaneous syndrome | Oculomucocutaneous syndrome |
| 108695146 | 10869514 | Oral mucosa erosion | |
| 108695146 | 10869514 | Oral mucosal eruption | |
| 108695146 | 10869514 | Oral mucosal erythema | |
| 108695146 | 10869514 | Oropharyngeal pain | |
| 108695146 | 10869514 | Pharyngeal erythema | |
| 108695146 | 10869514 | Pharyngitis | |
| 108695146 | 10869514 | Psychiatric symptom | |
| 108695146 | 10869514 | Pyrexia | |
| 108695146 | 10869514 | Rash | |
| 108695146 | 10869514 | Rash erythematous | |
| 108695146 | 10869514 | Scab | |
| 108695146 | 10869514 | Shock | |
| 108695146 | 10869514 | Skin exfoliation | |
| 108695146 | 10869514 | Stevens-Johnson syndrome | Stevens-Johnson syndrome |
| 108695146 | 10869514 | Swelling face | |
| 108695146 | 10869514 | Toxicity to various agents |
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 |
|---|---|---|---|---|---|---|
| 108695146 | 10869514 | 1 | 20150109 | 20150122 | 0 | |
| 108695146 | 10869514 | 2 | 20141208 | 20150121 | 0 | |
| 108695146 | 10869514 | 3 | 20141208 | 20150121 | 0 | |
| 108695146 | 10869514 | 4 | 20141208 | 20150121 | 0 | |
| 108695146 | 10869514 | 5 | 20141208 | 20150121 | 0 | |
| 108695146 | 10869514 | 6 | 20150109 | 20150121 | 0 | |
| 108695146 | 10869514 | 7 | 20141208 | 20150121 | 0 | |
| 108695146 | 10869514 | 8 | 20150216 | 0 |