Skip to main content

Table 2 Summary of safety in the whole population in PRECONNECT and by duration of FTD/TPI treatment

From: Safety and efficacy of trifluridine/tipiracil in previously treated metastatic colorectal cancer: final results from the phase IIIb single-arm PRECONNECT study by duration of therapy

 

Frequency in each population, n (%)

TEAE, n (%)

All

0–3 cycles

4–7 cycles

≥8 cycles

N = 914

n = 632

n = 219

n = 63

Any TEAE

883 (96.6)

611 (96.7)

209 (95.4)

63 (100.0)

Severe TEAE (grade ≥ 3)

683 (74.7)

466 (73.7)

160 (73.1)

57 (90.5)

 Most frequent severe TEAE (grade ≥ 3)

  Neutropeniaa

355 (38.8)

180 (28.5)

127 (58.0)

48 (76.2)

  Anaemiaa

103 (11.3)

65 (10.3)

30 (13.7)

8 (12.7)

  Astheniaa

49 (5.4)

36 (5.7)

10 (4.6)

3 (4.8)

  Diarrhoea

39 (4.3)

27 (4.3)

8 (3.7)

4 (6.3)

 Severe TEAE (grade ≥ 3) of interest

  Febrile neutropeniaa

11 (1.2)

8 (1.3)

2 (0.9)

1 (1.6)

  Cardiac disordersa

6 (0.7)

5 (0.8)

1 (0.5)

TEAE related to study drug

721 (78.9)

461 (72.9)

199 (90.9)

61 (96.8)

Severe TEAE (grade ≥ 3) related to study drug

459 (50.2)

262 (41.5)

144 (65.8)

53 (84.1)

 Most frequent severe TEAE (grade ≥ 3) related to study drug

  Neutropeniaa

348 (38.1)

175 (27.7)

126 (57.5)

47 (74.6)

  Anaemiaa

66 (7.2)

37 (5.9)

23 (10.5)

6 (9.5)

  Astheniaa

31 (3.4)

21 (3.3)

8 (3.7)

2 (3.2)

  Diarrhoea

28 (3.1)

21 (3.3)

5 (2.3)

2 (3.2)

 Severe TEAE (grade ≥ 3) of interest related to study drug

  Febrile neutropeniaa

11 (1.2)

8 (1.3)

2 (0.9)

1 (1.6)

  Cardiac disordersa

1 (0.1)

1 (0.2)

TEAE leading to study drug withdrawal

195 (21.3)

169 (26.7)

20 (9.1)

6 (9.5)

TEAE leading to study drug dose reduction

106 (11.6)

57 (9.0)

36 (16.4)

13 (20.6)

 Study drug-related

93 (10.2)

48 (7.6)

32 (14.6)

13 (20.6)

TEAE leading to study drug delay or temporary interruption

481 (52.5)

285 (44.9)

145 (66.2)

51 (81.0)

 Study drug-related

384 (42.0)

206 (32.6)

131 (59.8)

47 (74.6)

  1. aAnalysed per group term. TEAE, treatment-emergent adverse event