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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 110468942 | 11046894 | 2 | F | 201502 | 20160727 | 20150420 | 20160810 | EXP | CH-SM-2015-01856 | CH-UCBSA-2015011468 | UCB | 59.78 | YR | M | Y | 0.00000 | 20160810 | MD | CH | CH |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 110468942 | 11046894 | 1 | PS | Phenhydan | PHENYTOIN | 1 | Oral | 100 MG, 2X/DAY (BID) | 5400 | MG | Y | U | 0 | 100 | MG | TABLET | BID | ||
| 110468942 | 11046894 | 2 | SS | Phenhydan | PHENYTOIN | 1 | Intravenous (not otherwise specified) | 750 MG, UNK | Y | U | 0 | 750 | MG | SOLUTION FOR INFUSION | |||||
| 110468942 | 11046894 | 3 | SS | ZINACEF | CEFUROXIME SODIUM | 1 | Intravenous (not otherwise specified) | 1.5 G, 3X/DAY (TID) (ONCE EVERY 8 HOUR) | 4 | G | U | 0 | 1.5 | G | TID | ||||
| 110468942 | 11046894 | 4 | SS | PANTOZOL | PANTOPRAZOLE SODIUM | 1 | Oral | 20 MG, ONCE DAILY (QD) | Y | N | 0 | 20 | MG | TABLET | QD | ||||
| 110468942 | 11046894 | 5 | C | KEPPRA | LEVETIRACETAM | 1 | Oral | 2X/12 HOURS (INITIAL DOSE: 500 MG 2Q12H ),1500MG 2X/12 HOURS | Y | U | 0 | FILM-COATED TABLET | |||||||
| 110468942 | 11046894 | 6 | C | Urbanyl | CLOBAZAM | 1 | Oral | 0.5 DF, 2X/DAY (BID) (10MG | 7 | MG | U | 0 | .5 | DF | TABLET | BID | |||
| 110468942 | 11046894 | 7 | C | RIVOTRIL | CLONAZEPAM | 1 | 0.5 MG, DOSAGE FORM : VIALS | U | 0 | .5 | MG | SOLUTION FOR INJECTION | |||||||
| 110468942 | 11046894 | 8 | C | PERFALGAN | ACETAMINOPHEN | 1 | Intravenous (not otherwise specified) | 1 G, DOSAGE FORM : INFUSION AMPOULES, BAGS | U | 0 | 1 | G | |||||||
| 110468942 | 11046894 | 9 | C | NOVALGIN | METAMIZOLE SODIUM | 1 | Oral | 500 MG, UNK | Y | U | 0 | 500 | MG | FILM-COATED TABLET | |||||
| 110468942 | 11046894 | 10 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 16 MG, UNK | U | 0 | 16 | MG | |||||||
| 110468942 | 11046894 | 11 | C | FENTANYL. | FENTANYL | 1 | Intravenous (not otherwise specified) | 650 ?G, UNK | U | 0 | 650 | UG | |||||||
| 110468942 | 11046894 | 12 | C | Disoprivan | PROPOFOL | 1 | Intravenous (not otherwise specified) | 864 MG, UNK | U | 0 | 864 | MG | |||||||
| 110468942 | 11046894 | 13 | C | Esmeron | ROCURONIUM BROMIDE | 1 | Intravenous (not otherwise specified) | 100 MG, DOSAGE FORM : VIALS | U | 0 | 100 | MG | SOLUTION FOR INJECTION | ||||||
| 110468942 | 11046894 | 14 | C | Ephedrin | EPHEDRINE HYDROCHLORIDE | 1 | 10 MG, UNK | U | 0 | 10 | MG | ||||||||
| 110468942 | 11046894 | 15 | C | ULTIVA | REMIFENTANIL HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 3795 ?G, UNK | U | 0 | 3795 | UG | TABLET | ||||||
| 110468942 | 11046894 | 16 | C | MANNITOL. | MANNITOL | 1 | Intravenous (not otherwise specified) | 200 ML, UNK | U | 0 | 200 | ML | |||||||
| 110468942 | 11046894 | 17 | C | Fraxiparine | NADROPARIN CALCIUM | 1 | Subcutaneous | DOSGAE FORM : VIALS | U | 0 | 50 | MG | SOLUTION FOR INJECTION | ||||||
| 110468942 | 11046894 | 18 | C | PRIMPERAN | METOCLOPRAMIDE HYDROCHLORIDE | 1 | Oral | 10 MG, UNK | U | 0 | 10 | MG | TABLET | ||||||
| 110468942 | 11046894 | 19 | C | RANITIDINE. | RANITIDINE | 1 | U | 0 | |||||||||||
| 110468942 | 11046894 | 20 | C | Clobazam | CLOBAZAM | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 110468942 | 11046894 | 1 | Partial seizures |
| 110468942 | 11046894 | 2 | Partial seizures |
| 110468942 | 11046894 | 3 | Antibiotic prophylaxis |
| 110468942 | 11046894 | 4 | Gastrooesophageal reflux prophylaxis |
| 110468942 | 11046894 | 5 | Partial seizures |
| 110468942 | 11046894 | 6 | Partial seizures |
| 110468942 | 11046894 | 7 | Partial seizures |
| 110468942 | 11046894 | 8 | Postoperative analgesia |
| 110468942 | 11046894 | 9 | Postoperative analgesia |
| 110468942 | 11046894 | 10 | Craniotomy |
| 110468942 | 11046894 | 11 | Craniotomy |
| 110468942 | 11046894 | 12 | Craniotomy |
| 110468942 | 11046894 | 13 | Craniotomy |
| 110468942 | 11046894 | 14 | Craniotomy |
| 110468942 | 11046894 | 15 | Craniotomy |
| 110468942 | 11046894 | 16 | Craniotomy |
| 110468942 | 11046894 | 17 | Thrombosis prophylaxis |
| 110468942 | 11046894 | 18 | Product used for unknown indication |
| 110468942 | 11046894 | 19 | Product used for unknown indication |
| 110468942 | 11046894 | 20 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 110468942 | 11046894 | HO |
| 110468942 | 11046894 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 110468942 | 11046894 | Arthralgia | |
| 110468942 | 11046894 | Drug reaction with eosinophilia and systemic symptoms | |
| 110468942 | 11046894 | Eosinophilia | |
| 110468942 | 11046894 | Hepatitis | |
| 110468942 | 11046894 | Lymphocyte morphology abnormal | |
| 110468942 | 11046894 | Pruritus | |
| 110468942 | 11046894 | Pyrexia | |
| 110468942 | 11046894 | Rash maculo-papular |
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 |
|---|---|---|---|---|---|---|
| 110468942 | 11046894 | 1 | 20150130 | 20150306 | 0 | |
| 110468942 | 11046894 | 3 | 20150115 | 20150115 | 0 | |
| 110468942 | 11046894 | 4 | 201501 | 20150309 | 0 | |
| 110468942 | 11046894 | 5 | 20150127 | 20150306 | 0 | |
| 110468942 | 11046894 | 6 | 20150129 | 20150204 | 0 | |
| 110468942 | 11046894 | 7 | 20150130 | 20150130 | 0 | |
| 110468942 | 11046894 | 8 | 201501 | 201502 | 0 | |
| 110468942 | 11046894 | 9 | 201501 | 20150311 | 0 | |
| 110468942 | 11046894 | 10 | 20150115 | 20150116 | 0 | |
| 110468942 | 11046894 | 11 | 20150115 | 20150116 | 0 | |
| 110468942 | 11046894 | 12 | 20150115 | 20150115 | 0 | |
| 110468942 | 11046894 | 13 | 20150115 | 20150115 | 0 | |
| 110468942 | 11046894 | 14 | 20150115 | 20150115 | 0 | |
| 110468942 | 11046894 | 15 | 20150115 | 20150115 | 0 | |
| 110468942 | 11046894 | 16 | 20150115 | 20150115 | 0 | |
| 110468942 | 11046894 | 17 | 201501 | 201501 | 0 | |
| 110468942 | 11046894 | 18 | 201501 | 201501 | 0 |