Table 3 Overview of treatment-emergent adverse events

From: A phase 2 randomised study of veliparib plus FOLFIRI±bevacizumab versus placebo plus FOLFIRI±bevacizumab in metastatic colorectal cancer

n, %

Veliparib + FOLFIRI ± Bevacizumab (N = 65)

Placebo + FOLFIRI ± Bevacizumab (N = 65)

P-valuea

All grade AE

62 (95%)

61 (94%)

–

All grade AE related to veliparib

43 (66%)

44 (68%)

–

Grade 3 or 4 AE

53 (82%)

51 (79%)

–

Grade 3 or 4 AE related to veliparib

23 (35%)

21 (32%)

–

SAE

30 (46%)

33 (51%)

–

SAE related to veliparib

8 (12%)

8 (12%)

–

AE leading to veliparib discontinuationb

12 (19%)

14 (22%)

–

AE leading to veliparib reduction or interruption

44 (68%)

45 (69%)

–

All grade haematopoietic cytopenias

51 (79%)

34 (52%)

0.003

Haematopoietic erythropenias

25 (39%)

12 (19%)

0.019

Haematopoietic leukopenias

47 (72%)

28 (43%)

0.001

Any neutropenia and lymphopenia

46 (71%)

28 (43%)

0.002

Fatal AE

2 (3%)

2 (3%)

–

Deathsc

27 (42%)

27 (42%)

–

  1. AE adverse event
  2. a P-value for difference between treatment groups from Fisher’s Exact Test. Only P-values <0.05 are presented
  3. b Includes adverse events related to progression and not related to progression
  4. c Includes all treatment-emergent deaths and deaths that occurred >30 days after last dose
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