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Table 2 Adverse events in ≥2 patients

From: MTRX1011A, a humanized anti-CD4 monoclonal antibody, in the treatment of patients with rheumatoid arthritis: a Phase I randomized, double-blind, placebo-controlled study incorporating pharmacodynamic biomarker assessments

 

SAD Stage

MD Stage

No. (%) Patients

Placebo

(n= 6)

All Active

(n= 24)

Placebo

(n= 7)

1.5 mg/kg (SC) (n= 12)

3.5 mg/kg (SC) (n= 12)

5.0 mg/kg (IV)(n= 5)

All Active(n= 29)

Adverse Events

       

   Any event

1 (17)

6 (25)

0 (0)

1 (8)

3 (25)

1 (20)

5 (17)

   Nausea

0 (0)

2 (8)

0 (0)

0 (0)

1 (8)

0 (0)

1 (3)

   Flank pain

0 (0)

2 (8)

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

   Fatigue

0 (0)

0 (0)

0 (0)

1 (8)

1 (8)

0 (0)

2 (7)

   Pruritis

0 (0)

0 (0)

0 (0)

0 (0)

1 (8)

1 (20)

2 (7)

   Rash

0 (0)

0 (0)

0 (0)

0 (0)

1 (8)

1 (20)

2 (7)

Serious Adverse Events

       

Any event

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

  1. IV, intravenous; MD, multiple dose; SAD, single ascending dose; SC, subcutaneous.
  2. *Adverse events determined by investigators to be related to MTRX1011A by preferred term in ≥ 2 patients.