Table 6. Summary of adverse events by fixed duration vs variable duration randomisation.

	Variable-duration	Fixed-duration	Total	p-value *
Number randomised	N=100	N=102	N=202
Median weeks follow-up (IQR)	49.0 (29.0, 54.4)	32.0 (32.0, 33.0)	32.1 (31.2, 50.4)
SAEs	5 (5%) [5]	5 (5%) [5]	10 (5%) [10]	p=1.00
Life-threatening	1 (1%) [1]	1 (1%) [1]	2 (1%) [2]
Required or prolonged hospitalisation	5 (5%) [5]	4 (4%) [4]	9 (4%) [9]
Other important medical condition	0	1 (1%) [1]	1 (<1%) [1]
Relationship to trial drug (% of SAEs)
Unlikely	2 (40%)	2 (40%)	4 (40%)
Not related	3 (60%)	3 (60%)	6 (60%)
Severe AEs	9 (9%) [16]	5 (5%) [5]	14 (7%) [21]	p=0.28
Relationship to trial drug (% of severe AEs)
Definitely	8 (50%)	0	8 (38%)
Probably	2 (13%)	2 (40%)	4 (19%)
Possibly	3 (19%)	0	3 (14%)
Unlikely	0	1 (20%)	1 (5%)
Not related	3 (19%)	2 (40%)	5 (24%)
AEs probably/definitely related to first-line drugs	3 (3%) [3]	1 (1%) [1]	4 (2%) [4]	p=0.37
AEs probably/definitely related to retreatment drugs	3 (3%) [7]	1 (1%) [1]	4 (2%) [8]	p=0.37
First-line drug changes due to AEs	3 (3%) [3]	1 (1%) [1]	4 (2%) [4]	p=0.37
Retreatment drug changes due to AEs	6 (6%) [11]	1 (1%) [1]	7 (3%) [12]	p=0.06
Grade 3/4 anaemia	3(3%) [3]	0	3 (1%) [3]	p=0.12

*p-values calculated using chi-square tests or Fishers exact test when numbers are small.

Note: no. of patients (% of patients) [no. of events]. Tables include data for both first-line and retreatment phases. For SAEs, HR=0.77 (0.21, 2.80) p=0.69. For severe (grade 3/4 AEs), HR=1.74 (0.58, 5.24) p=0.33.