Table 5:

Reporting element results and association with trial phase and size

		Odds ratio (95% CI)*
Reporting element	Yes/Total trial number (%)	Phase II vs I	Trial size ≥40 vs <40
Were treatment-related toxicities reported?**	139/209 (67%)	0.5 (0.3-1.1); p=0.08	0.8 (0.4-1.6); p=0.49
Were treatment-emergent toxicities reported?**	70/209 (33%)	0.3 (0.2-0.6); p<0.01	1.0 (0.5-1.8); p=0.94
Was a dose-escalation component included?	99/209 (47%)	N/A†	0.4 (0.2-0.7); p<0.01
Were adverse events combined across dose levels if dose-escalation was included? (n=99)	46/99 (46%)	N/A†	1.9 (0.8-4.5); p=0.12
Were dose-limiting toxicities reported if the trial included a dose-escalation component? (n=99)	67/99 (68%)	N/A†	0.7 (0.3-1.7); p=0.45
Were key dose-limiting toxicity criteria described?	21/67 (31%)	N/A†	1 (0.3-3.1); p=0.95
Were serious adverse events reported?	68/209 (33%)	0.4 (0.2-0.7); p<0.01	0.9 (0.5-1.6); p=0.65
Were key serious adverse event criteria described?	0/68 (0%)	-	-
Were adverse events leading to treatment change reported?	89/209 (43%)	0.9 (0.5-1.5); p=0.59	2.5 (1.4-4.4); p=<0.01
Were standardized terminology (CTCAE or MedDRA) utilized?	180/209 (86%)	1.1 (0.5-2.3); p=0.89	1 (0.4-2.1); p=0.96
Were grouped adverse event terms utilized?	48/209 (23%)	1.6 (0.9-3.2); p=0.13	1.9 (1-3.7); p=0.05
Was overall incidence of adverse events at organ system level reported?	7/209 (3%)	1.8 (0.4-8.4); p=0.43	2.8 (0.5-14.9); p=0.20
Was the total number of patients with any adverse event any grade reported?	92/209 (44%)	0.8 (0.5-1.5); p=0.54	1.7 (1-3); p=0.05
Was the total number of patients with any adverse event grade ≥3 reported?	92/209 (44%)	1 (0.6-1.7); p=0.96	2.6 (1.5-4.5); p<0.01

^*Using unadjusted logistic regression. Bold indicates p-values less than 0.05.

^**27 studies did not specify if AE were treatment-related or treatment-emergent; these 27 studies were excluded from logistic regression.

^†Dose-escalation by definition includes only phase I trials.