Table IV.

Toxicities reported on previous clinical trials in children with DS-ALL.

Study name	Patient cohort	Cardiac toxicity	Respiratory toxicity	Sepsis	Liver toxicity	Neuro toxicity
Patrick et al (2014)	86 DS-ALL on UKALL 2003	–	–	34 infections. 3 fungal infections	Described	2 seizures
Buitenkamp et al (2014)	653 DS-ALL on multiple trials	–	Pulmonary infection described	38 infectious deaths	–	–
Maloney et al (2006)	20 DS-ALL on AALL0232, 26 DS-ALL on AALL0331	Described	–	Described	–	–
de la Fuente et al (2005)	37 DS-ALL on UK MRC ALL 97	1 cardiac death.	–	8 infectious deaths	–	–
Bassal et al (2005)	59 DS-ALL on CCG-1952	–	–	Described	–	–
Chessells et al (2001)	55 DS-ALL on UK MRC ALL X or XI	–	–	4 infectious deaths	–	–
Dordelmann et al (1998)	61 DS-ALL on BFM 81, 83, 86 and 90	2 cardiac toxicities	Pulmonary infection described	Described	–	–
Ragab et al (1991)	33 DS-ALL on POG trials	–	–	14 Grade 3/4 toxicities	3 Grade 3/4 toxicities	–
Kalwinsky et al (1990)	28 DS-ALL on SJCRH trials	1 cardiac death	33% bronchitis 26% pneumonia	29% sepsis in induction	–	4% seizures
Levitt et al (1990)	63 DS-ALL on multiple trials	2 cardiac deaths	–	16 infectious deaths	–	1 case of status epilepticus
Robison et al (1984)	95 DS-ALL on CCSG trials	1 cardiac death	7 pneumonia deaths	6 bacterial sepsis deaths	–	1 death due to CNS haemorrhage

DS, Down syndrome; ALL, acute lymphoblastic leukaemia; CNS, central nervous system; UK MRC, United Kingdom Medical Research Council; CCG, Children’s Cancer Group; BFM, Berlin-Frankfurt-Munster Group; POG, Pediatric Oncology Group; SJCRH, St. Jude’s Childrens’ Research Hospital; CCSG, Childrens Cancer Study Group.

^–Indicates not reported in manuscript.