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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127562221 | 12756222 | 1 | I | 20160906 | 20160916 | 20160916 | EXP | US-GLAXOSMITHKLINE-US2016GSK134228 | GLAXOSMITHKLINE | CAMARGO JF, MORRIS MI, ABBO LM, SIMKINS J, SANEEYMEHRI S, ALENCAR MC ET AL. THE USE OF BRINCIDOFOVIR FOR THE TREATMENT OF MIXED DSDNA VIRAL INFECTION. JOURNAL OF CLINICAL VIROLOGY. 2016;82:1-4 | 24.00 | YR | F | Y | 0.00000 | 20160916 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127562221 | 12756222 | 1 | SS | TACROLIMUS. | TACROLIMUS | 1 | Y | 0 | |||||||||||
| 127562221 | 12756222 | 2 | SS | METHOTREXATE. | METHOTREXATE | 1 | U | 0 | |||||||||||
| 127562221 | 12756222 | 3 | SS | LEVOFLOXACIN. | LEVOFLOXACIN | 1 | Oral | 500 MG, QD | U | 0 | 500 | MG | QD | ||||||
| 127562221 | 12756222 | 4 | SS | FLUCONAZOLE. | FLUCONAZOLE | 1 | Oral | 400 MG, QD | U | 0 | 400 | MG | QD | ||||||
| 127562221 | 12756222 | 5 | PS | ACYCLOVIR. | ACYCLOVIR | 1 | Oral | 800 MG, BID | U | 18603 | 800 | MG | BID | ||||||
| 127562221 | 12756222 | 6 | SS | Trimethoprim + sulfamethoxazole | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 80/400 MG PER OS THREE TIMES A WEEK | U | 0 | |||||||||
| 127562221 | 12756222 | 7 | SS | BUSULFAN. | BUSULFAN | 1 | U | 0 | |||||||||||
| 127562221 | 12756222 | 8 | SS | GANCICLOVIR. | GANCICLOVIR | 1 | Intravenous (not otherwise specified) | 2.5 MG/KG Q12 H | U | 0 | 2.5 | MG/KG | |||||||
| 127562221 | 12756222 | 9 | SS | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | U | 0 | |||||||||||
| 127562221 | 12756222 | 10 | SS | ANTI-THYMOCYTE GLOBULIN | THYMOCYTE IMMUNE GLOBULIN NOS | 1 | 4 MG/KG, UNK | U | 0 | 4 | MG/KG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127562221 | 12756222 | 1 | Prophylaxis against graft versus host disease |
| 127562221 | 12756222 | 2 | Prophylaxis against graft versus host disease |
| 127562221 | 12756222 | 3 | Antibiotic prophylaxis |
| 127562221 | 12756222 | 4 | Antibiotic prophylaxis |
| 127562221 | 12756222 | 5 | Antibiotic prophylaxis |
| 127562221 | 12756222 | 6 | Antibiotic prophylaxis |
| 127562221 | 12756222 | 7 | Stem cell transplant |
| 127562221 | 12756222 | 8 | Product used for unknown indication |
| 127562221 | 12756222 | 9 | Stem cell transplant |
| 127562221 | 12756222 | 10 | Stem cell transplant |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127562221 | 12756222 | DE |
| 127562221 | 12756222 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127562221 | 12756222 | Adenovirus infection | |
| 127562221 | 12756222 | Adrenal insufficiency | |
| 127562221 | 12756222 | BK virus infection | |
| 127562221 | 12756222 | Condition aggravated | |
| 127562221 | 12756222 | Cystitis haemorrhagic | |
| 127562221 | 12756222 | Cytomegalovirus infection | |
| 127562221 | 12756222 | Drug resistance | |
| 127562221 | 12756222 | Epstein-Barr virus infection | |
| 127562221 | 12756222 | Graft versus host disease | |
| 127562221 | 12756222 | Hepatic enzyme increased | |
| 127562221 | 12756222 | Immune reconstitution inflammatory syndrome | |
| 127562221 | 12756222 | Lymphopenia | |
| 127562221 | 12756222 | Obstructive uropathy | |
| 127562221 | 12756222 | Pneumonitis | |
| 127562221 | 12756222 | Pyrexia | |
| 127562221 | 12756222 | Renal failure | |
| 127562221 | 12756222 | Respiratory failure | |
| 127562221 | 12756222 | Sepsis | |
| 127562221 | 12756222 | Thrombocytopenia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |