Table 3.

Events in standard arm by treatment phase

	Intensive phase (Month 0–2) n = 639	Continuation phase (Month 3–6) n = 596	Follow Up phase (Month 7–18) n = 569
Total Grade 3 & 4 AEs Reported	135	62	53
Related	80	29	4
(% Total)	(59.3%)	(46.8%)	(7.5%)
No of Grade 3 AEs Reported	100	48	33
Related	50	23	3
(%Grade3)	(50.0%)	(57.5%)	(9.1%)
No. Grade 4 AEs Reported	35	14	20
Related	30	6	1
(%Grade4)	(85.7%)	(42.9%)	(5.0%)
System Organ Class of Related Events*
Hepatobiliary	25	13	0
Musculoskeletal	15	7	0
Metabolism & Nutrition	9	1	2
Blood & Lymphatic	5	2	1
No of Related Grade 3 or 4 AEs per Patient
0	592	581	566
1	33	12	2
2	10	1	1
≥ 3	4	2	0
No of Patients with ≥ 1 SAE (% n)	32 (5.0%)	18 (3.0%)	20 (3.5%)
No of Patients with ≥ 1 Related SAE (%n)	17 (2.7%)	3 (0.5%)	2 (0.4%)
Mean No of SAEs per Patient	1.78	1.39	1.60
No of Withdrawals	38	26	1
No of Deaths	5	1	10

The number of grade 3 & 4 adverse events (total and related only) recorded in each treatment arm are shown with percentage of the total number of similar events across all treatment phases. Most common System Organ Classes for grade 3 & 4 adverse events are tabulated by treatment phase, along with tallies of patients in each phase split by the number of grade 3 or 4 adverse events experienced in the treatment phase. Serious adverse events in each phase are also shown, regardless of their severity grading. The denominator for each treatment phase was determined by subtracting the number of withdrawals and deaths from the denominator in the previous phase. The treatment phases were not independent and the same patient could appear in all three of the phases. *Note that some events excluded because of undocumented onset date