. 2021 Mar 2;325(9):833–842. doi: 10.1001/jama.2021.0669

Table 2. Outcomes in a Study of the Effect of Postreinduction Consolidation With Blinatumomab vs Chemotherapy in Children, Adolescents, and Young Adults With First Relapse of B-Cell Acute Lymphoblastic Leukemia.

End point	No. (%)		Absolute difference (95% CI), %	Odds ratio (95% CI)^a	P value^a
End point	Blinatumomab (n = 105)	Chemotherapy (n = 103)	Absolute difference (95% CI), %	Odds ratio (95% CI)^a	P value^a
First event (components of the primary end point)^b
Late treatment failure^c	1 (1)	9 (9)	−8 (−14 to −2)
Relapse	35 (33)	32 (31)	2 (−10 to 15)
Death	12 (11)	18 (17)	−6 (−16 to 3)
Exploratory end points^d
Negative MRD at the end of reinduction	26 (25)	31 (30)	−5 (−17 to 7)	0.76 (0.4 to 1.5)^e	.39
Negative MRD at the end of cycle 1	79 (75)	33 (32)	43 (31 to 55)	6.4 (3.4 to 12.4)^e	<.001
Negative MRD at the end of cycle 2	69 (66)	33 (32)	34 (21 to 46)	4.1(2.2 to 7.6)^e	<.001
Underwent hematopoietic stem cell transplant^f	74 (70)	44 (43)	27 (15 to 41)	3.2 (1.7 to 5.9)	<.001

^{^a}

Odds ratios and P values are not shown for the comparisons of event rates because these are competing events.

^{^b}

All events but 1 took place within 2 years of randomization.

^{^c}

Late treatment failure was defined as ≥5% blasts in marrow after cycle 1.

^{^d}

Minimal residual disease (MRD) is ascertained by assays of blood specimens that use polymerase chain reactions or flow cytometry to detect acute lymphoblastic leukemia cells; MRD is defined by the presence of at least 0.01% acute lymphoblastic leukemia cells in a posttreatment blood specimen and predicts the likelihood of relapse. Negative MRD is defined as MRD less than 0.01%.

^{^e}

The odds ratio for negative MRD represents the odds of negative MRD in the blinatumomab group vs the chemotherapy group. In this analysis, positive MRD (defined as MRD ≥0.01% or MRD <0.1% with sensitivity of 1 in 1000) or no MRD data are considered as not having negative MRD. The rationale for including patients with no MRD data in this analysis is that the lack of MRD data was due to death, relapse, or removal from protocol therapy because of an adverse event or other poor response to therapy, so it is appropriate to include them as the converse of the optimal outcome of being able to submit a sample and have negative MRD.

^{^f}

Received transplant without intervening nonprotocol therapy.