Table 2 Overall TEAEs in all patients of the phase 1 main study and two fractional dose treatment groups

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

 

TSR-011 IR formulation

 

20 mg Q8h (n = 16)

40 mg Q8h (n = 31)

All patients (N = 72)

Total number of TEAEsa

159

167

621

Number (%) of patients with

  Any TEAE

16 (100.0)

29 (93.5)

70 (97.2)

  Any serious TEAE

7 (43.8)

12 (38.7)

28 (38.9)

  Any study drug-related TEAE

9 (56.3)

13 (41.9)

40 (55.6)

  Any TEAE leading to treatment discontinuation

2 (12.5)

5 (16.1)

11 (15.3)

  Any AE leading to deathb

2 (12.5)

2 (6.5)

6 (8.3)

  1. AE adverse event, IR immediate release, Q8h once every 8 hours, TEAE treatment-emergent adverse event
  2. Note: The total number of AEs counted all TEAEs for patients
  3. aAt each level of patient summarisation, a patient was counted once if the patient reported one or more event
  4. bNo AEs leading to death were deemed related to treatment
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