Journal of Immunology Research / 2016 / Article / Tab 1

Research Article

Immunogenicity Assessment of Lipegfilgrastim in Patients with Breast Cancer Receiving Chemotherapy

Table 1

Summary of patients with ADA-positive samples.

Phase II study
PatientTreatment groupVisit
BLC2D1C3D1C4D1D85D180D360ET

1LipegfilgrastimNegNegNegNegPosNANANA
2LipegfilgrastimNANANANANANAPosNA
3LipegfilgrastimPosPosPosPosPosPosPosNA
4LipegfilgrastimPosPosPosPosPosPosNegNA
5LipegfilgrastimPosPosNANANAPosPosNeg
6LipegfilgrastimPosNANANANANANANA
7LipegfilgrastimPosNANANANANANANA
8LipegfilgrastimPosNANANANANANegNA
9LipegfilgrastimPosNANANANANANANA
10PegfilgrastimNANANANAPosNANANA
11PegfilgrastimPosNANANANANANANA
12PegfilgrastimPosNANANANANANANA

Phase III study
PatientTreatment groupVisit
SBLC2D1C3D1C4D1D85D180D360

13LipegfilgrastimNANANANANANAPosPos
14LipegfilgrastimNAPosPosPosPosNegNegNeg
15LipegfilgrastimNAPosPosNegNegNegNegNeg
16LipegfilgrastimNAPosNANANANANANA
17PegfilgrastimNANANANANANANAPos
18PegfilgrastimNAPosNANANANANANA
19PegfilgrastimPosNANANANANANANA
20PegfilgrastimNAPosNANANANANANA
21PegfilgrastimNAPosNANANANANANA
22PegfilgrastimNAPosNegNANANANANA
23PegfilgrastimNAPosNANANANANANA

Note: table includes only patients with ADA-positive samples.
ADA: antidrug antibody; BL: baseline; C2D1: cycle 2 day 1; C3D1: cycle 3 day 1; C4D1: cycle 4 day 1; D85: day 85; D180: day 180; D360: day 360; NA: screened negative sample; Neg: confirmed-negative sample; Pos: confirmed-positive sample; S: screening (predose) time point.
Italic font indicates patient with treatment-emergent ADA.

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