Table 3 Grade 3 treatment-emergent adverse events reported by more than one patient in the Q8h cohorts compared with the safety population

From: A phase 1, open-label, dose-escalation trial of oral TSR-011 in patients with advanced solid tumours and lymphomas

Preferred term

TSR-011 IR formulation, n (%)

 

20 mg Q8h (n = 16)

40 mg Q8h (n = 31)

All patients (N = 72)

Anaemia

2 (12.5)

2 (6.5)

5 (6.9)

Electrocardiogram QTc prolonged

0

1 (3.2)

4 (5.6)

Asthenia

1 (6.3)

1 (3.2)

3 (4.2)

Dyspnoea

0

0

3 (4.2)

Ascites

1 (6.3)

0

2 (2.8)

Fatigue

1 (6.3)

0

2 (2.8)

Metastases to the central nervous system

1 (6.3)

1 (3.2)

2 (2.8)

  1. IR immediate release, Q8h once every 8 hours, QTc corrected QT
  2. Note: Adverse events were coded using the Medical Dictionary for Regulatory Activities, version 18.0. If the severity of an adverse event was missing, the adverse event was reported as “severe”
Back to article page