Development of standard definitions and grading for Maternal and Fetal Adverse Event Terminology.

OBJECTIVE: Adverse event (AE) monitoring is central to assessing therapeutic safety. The lack of a comprehensive framework to define and grade maternal and fetal AEs in pregnancy trials severely limits understanding risks in pregnant women. We created AE terminology to improve safety monitoring for developing pregnancy drugs, devices and interventions. METHOD: Existing severity grading for pregnant AEs and definitions/indicators of 'severe' and 'life-threatening' conditions relevant to maternal and fetal clinical trials were identified through a literature search. An international multidisciplinary group identified and filled gaps in definitions and severity grading using Medical Dictionary for Regulatory Activities (MedDRA) terms and severity grading criteria based on Common Terminology Criteria for Adverse Event (CTCAE) generic structure. The draft criteria underwent two rounds of a modified Delphi process with international fetal therapy, obstetric, neonatal, industry experts, patients and patient representatives. RESULTS: Fetal AEs were defined as being diagnosable in utero with potential to harm the fetus, and were integrated into MedDRA. AE severity was graded independently for the pregnant woman and her fetus. Maternal (n = 12) and fetal (n = 19) AE definitions and severity grading criteria were developed and ratified by consensus. CONCLUSIONS: This Maternal and Fetal AE Terminology version 1.0 allows systematic consistent AE assessment in pregnancy trials to improve safety.

Autologous stem cell transplantation and purging in adult acute lymphoblastic leukaemia.

The prognosis for adult acute lymphoblastic leukaemia (ALL) is poor. Only 20-30% of patients will be cured with conventional chemotherapy. Haematopoietic progenitor transplantation is thus an attractive option in these patients. Even if allogeneic transplantation allows a better control of the disease, autologous transplantation remains an important alternative for patients lacking a suitable donor or when allogeneic transplants imply excessive risk. Relapse is the main drawback of autologous transplants, but many strategies are being explored to overcome this problem. We focus here on transplant modality, the source of haematopoietic progenitors, and the best timing to apply the procedure. Also reviewed are the current situation and future strategies for improving results in this setting, such as ex vivo purging; immunotherapy and maintenance chemotherapy.

Evaluación y prevención de las complicaciones orales en los pacientes trasplantados de médula ósea. Estudio clínico / Evaluation and prevention of oral complications in patients subjected to bone marrow transplantation. A clinical study

Objetivo: Analizar la relación entre el grado de inflamación gingival de un grupo de pacientes trasplantados de médula ósea y el tipo de mucositis que presentan. Diseño: Se estudian 58 pacientes con enfermedad hematológica que son trasplantados de médula ósea. La población se clasifica en tres grupos: grupo A (pacientes vistos antes y después de la infusión), grupo B (pacientes explorados sólo después de la infusión) y grupo C (todos los pacientes vistos después de la infusión). Se realiza un protocolo de exploración antes, durante y después del tratamiento. Los resultados se procesan mediante el paquete estadístico SPSS+ Windows, realizándose un análisis descriptivo. Resultados: El CAOd registrado es de 10,7. El índice de sangrado antes de la infusión es del 10 por ciento, pasando al 15 por ciento post-infusión (22 por ciento si se considera el grupo C). El índice gingival pre-tratamiento es de 1,6 (grupo A), pasando a 1,3 post-trasplante y siendo de 1,9 para él grupo B. El índice de placa pasa de 1,8 a 1,4 en el grupo A y es de 2,1 en el grupo B. El 82 por ciento de los pacientes presentan mucositis de gradó II, III ó IV. La correlación entre índice gingival mayor o menor de 1,5 y grado de mucositis presentado es estadísticamente significativa, con una p<0,000.Conclusiones: La visita previa al paciente que será transplantado implica un mejor índice gingival post-trasplante. El mayor grado de inflamación gingival conlleva un mayor grado de mucositis. Es importante controlar la inflamación gingival como medida para prevenir la mucositis (AU)