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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126914471 | 12691447 | 1 | I | 20160819 | 20160826 | 20160826 | EXP | BE-MYLANLABS-2016M1035916 | MYLAN | BAUTERS T, BORDON V, FLORIN L, PADALKO E, ANDREI G, GILLEMOT S, ET AL. MULTIDRUG-RESISTANT CYTOMEGALOVIRUS INFECTION IN A PEDIATRIC STEM CELL TRANSPLANTATION PATIENT. ANTIVIRAL-RES 2016;132:149-153. | 0.00 | Y | 0.00000 | 20160826 | OT | BE | BE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126914471 | 12691447 | 1 | PS | CIDOFOVIR. | CIDOFOVIR | 1 | Unknown | U | 201276 | ||||||||||
| 126914471 | 12691447 | 2 | SS | GANCICLOVIR. | GANCICLOVIR | 1 | Unknown | 4 WEEKS LATER DOSE FREQUENCY REDUCED TO ONCE DAILY | U | 0 | 5 | MG/KG | BID | ||||||
| 126914471 | 12691447 | 3 | SS | GANCICLOVIR. | GANCICLOVIR | 1 | Unknown | 1 WEEKS LATER DOSE FREQUENCY CHANGED AGAIN TO TWICE DAILY | U | 0 | 5 | MG/KG | QD | ||||||
| 126914471 | 12691447 | 4 | SS | GANCICLOVIR. | GANCICLOVIR | 1 | Unknown | 1 WEEKS LATER DOSE FREQUENCY CHANGED AGAIN TO TWICE DAILY (DOUBLE DOSE ACCORDING TO BODY WEIGHT) | U | 0 | |||||||||
| 126914471 | 12691447 | 5 | SS | FOSCARNET | FOSCARNET | 1 | Unknown | FOR MORE THAN 2 WEEKS | U | 0 | 350 | MG | BID | ||||||
| 126914471 | 12691447 | 6 | C | BUSULFAN. | BUSULFAN | 1 | Intravenous (not otherwise specified) | 16X1MG/KG | 0 | ||||||||||
| 126914471 | 12691447 | 7 | C | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Unknown | 4X35 MG/M2 | 0 | ||||||||||
| 126914471 | 12691447 | 8 | C | PHENOBARBITAL. | PHENOBARBITAL | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126914471 | 12691447 | 1 | Cytomegalovirus infection |
| 126914471 | 12691447 | 2 | Cytomegalovirus infection |
| 126914471 | 12691447 | 5 | Cytomegalovirus infection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126914471 | 12691447 | OT |
| 126914471 | 12691447 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126914471 | 12691447 | Cardiac arrest | |
| 126914471 | 12691447 | Encephalitis cytomegalovirus | |
| 126914471 | 12691447 | Multiple-drug resistance | |
| 126914471 | 12691447 | Respiratory arrest |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |