Reaching beyond maximum grade: progress and future directions for modernising the assessment and reporting of adverse events in haematological malignancies.

Remarkable improvements in outcomes for many haematological malignancies have been driven primarily by a proliferation of novel therapeutics over the past two decades. Targeted agents, immune and cellular therapies, and combination regimens have adverse event profiles distinct from conventional finite cytotoxic chemotherapies. In 2018, a Commission comprising patient advocates, clinicians, clinical investigators, regulators, biostatisticians, and pharmacists representing a broad range of academic and clinical cancer expertise examined issues of adverse event evaluation in the context of both newer and existing therapies for haematological cancers. The Commission proposed immediate actions and long-term solutions in the current processes in adverse event assessment, patient-reported outcomes in haematological malignancies, toxicities in cellular therapies, long-term toxicity and survivorship in haematological malignancies, issues in regulatory approval from an international perspective, and toxicity reporting in haematological malignancies and the real-world setting. In this follow-up report, the Commission describes progress that has been made in these areas since the initial report.

Assessment of maternal risk factors associated with low birth weight neonates at a tertiary hospital, Nanded, Maharashtra.

BACKGROUND: To assess the maternal risk factors associated with low birth weight (LBW) neonates at a tertiary hospital, Nanded, Maharashtra. MATERIALS AND METHODS: This study was carried out in a tertiary care hospital in Nanded city of Maharashtra between January 2014 and July 2014 among 160 cases (LBW-birth weight ≤2499 g) and 160 controls (normal birth weight-birth weight >2499. Data collection was done by using predesigned questionnaire and also related health documents were checked and collected the expected information during the interview after obtaining informed consent from mothers. The data were analyzed by Epi Info 7 Version. RESULTS: The present study found the significant association among gestational age, sex of baby, type of delivery, maternal age, religion, education of mother and husband, occupation of mother and husband, type of family, maternal height, weight gain, hemoglobin level, planned/unplanned delivery, bad obstetric history, interval between pregnancies, previous history of LBW, underlying disease, tobacco chewing, timing of first antenatal care (ANC) visit, total number of ANC visit, and iron and folic acid (IFA) tablets consumption with LBW. No significant association was found among maternal age, residence, caste, consanguinity of marriage, socioeconomic status, gravida, birth order, multiple pregnancy, and smoking with LBW in our study. CONCLUSION: It was concluded that hemoglobin level, weight gain during pregnancy, gestational age, planned/unplanned delivery, bad obstetric history, and IFA tablets consumption during pregnancy were independent risk factors for LBW.