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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118001384 | 11800138 | 4 | F | 20151116 | 20160712 | 20151203 | 20160720 | EXP | JP-ALLERGAN-1525115US | ALLERGAN | 2.00 | YR | M | Y | 0.00000 | 20160720 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118001384 | 11800138 | 1 | PS | BOTOX | ONABOTULINUMTOXINA | 1 | Intramuscular | 30 UNITS, SINGLE | 103000 | POWDER FOR INJECTION | QD | ||||||||
| 118001384 | 11800138 | 2 | SS | BOTOX | ONABOTULINUMTOXINA | 1 | Intramuscular | 30 UNITS, UNK | 103000 | POWDER FOR INJECTION | QD | ||||||||
| 118001384 | 11800138 | 3 | SS | BOTOX | ONABOTULINUMTOXINA | 1 | Intramuscular | 20 UNK, UNK | 103000 | POWDER FOR INJECTION | QD | ||||||||
| 118001384 | 11800138 | 4 | SS | BOTOX | ONABOTULINUMTOXINA | 1 | Intramuscular | 10 UNITS, SINGLE | 103000 | POWDER FOR INJECTION | QD | ||||||||
| 118001384 | 11800138 | 5 | C | DIAZEPAM. | DIAZEPAM | 1 | U | U | 0 | ||||||||||
| 118001384 | 11800138 | 6 | C | PHENOBAL | PHENOBARBITAL | 1 | U | U | 0 | ||||||||||
| 118001384 | 11800138 | 7 | C | DEPAKENE | VALPROIC ACID | 1 | U | U | 0 | ||||||||||
| 118001384 | 11800138 | 8 | C | EXCEGRAN | ZONISAMIDE | 1 | U | U | 0 | ||||||||||
| 118001384 | 11800138 | 9 | C | LIORESAL | BACLOFEN | 1 | U | U | 0 | ||||||||||
| 118001384 | 11800138 | 10 | C | TIZANIDINE. | TIZANIDINE | 1 | U | U | 0 | ||||||||||
| 118001384 | 11800138 | 11 | C | GASMOTIN | MOSAPRIDE CITRATE | 1 | U | U | 0 | ||||||||||
| 118001384 | 11800138 | 12 | C | LEVOCARNITINE HYDROCHLORIDE | LEVOCARNITINE HYDROCHLORIDE | 1 | U | U | 0 | ||||||||||
| 118001384 | 11800138 | 13 | C | MUCODYNE | CARBOCYSTEINE | 1 | U | U | 0 | ||||||||||
| 118001384 | 11800138 | 14 | C | MUCOSOLVAN | AMBROXOL HYDROCHLORIDE | 1 | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118001384 | 11800138 | 1 | Muscle spasms |
| 118001384 | 11800138 | 14 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118001384 | 11800138 | OT |
| 118001384 | 11800138 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118001384 | 11800138 | Dyspnoea | |
| 118001384 | 11800138 | Laryngitis | |
| 118001384 | 11800138 | Pneumonia | |
| 118001384 | 11800138 | Pyrexia | |
| 118001384 | 11800138 | Rhinorrhoea | |
| 118001384 | 11800138 | Viral infection | |
| 118001384 | 11800138 | Wheezing |
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 |
|---|---|---|---|---|---|---|
| 118001384 | 11800138 | 1 | 20151113 | 20151113 | 0 | |
| 118001384 | 11800138 | 2 | 20151113 | 20151113 | 0 | |
| 118001384 | 11800138 | 3 | 20151113 | 20151113 | 0 | |
| 118001384 | 11800138 | 4 | 20151113 | 20151113 | 0 |