373 476
[(Fig._2)TD$FIG]
–100
–75
–50
–25
0
25
50
75
100
12 0
24 36 48 60 72 84 96 108 120
–100
–75
–50
–25
0
25
50
75
100
12 0
24 36 48 60 72 84 96 108 120
–100
–75
–50
–25
0
25
50
75
100
12
0
24 36 48 60 72 84 96 108
Time since randomization (wk)
*
*
*
*
*
*
Change from baseline (%)
Before first progression After first progression Patients still on treatment
Complete/partial response
Stable disease
Progressive disease
n
= 31
n
= 51
n
= 70
C
B
A
Fig. 2 – Tumor burden change from randomization through treatment with nivolumab beyond progression based on best overall response prior to
treatment beyond progression of (A) complete/partial response, (B) stable disease, (C) progressive disease. Asterisks represent patients who were
treated beyond progression but who did not have scans beyond first progression to document tumor burden.
Table 4 – Treatment-related adverse events at and after first progression in
I
5% of patients treated with nivolumab
From randomization to first progression
After first progression
System organ class,
n
(%)
Patients treated beyond
progression (
n
= 153)
Patients not treated beyond
progression (
n
= 163)
Patients treated beyond
progression (
n
= 153)
Any grade
Grade 3 or 4
Any grade
Grade 3 or 4
Any grade
Grade 3 or 4
Total patients with an event
108 (71)
12 (8)
115 (71)
28 (17)
91 (59)
22 (14)
Fatigue
48 (31)
0
41 (25)
4 (2)
31 (20)
4 (3)
Diarrhea
18 (12)
1 (1)
14 (9)
2 (1)
11 (7)
0
Pruritus
17 (11)
0
11 (7)
0
12 (8)
0
Nausea
12 (8)
0
20 (12)
0
11 (7)
0
Rash
12 (8)
0
8 (5)
2 (1)
11 (7)
0
Decreased appetite
11 (7)
0
15 (9)
2 (1)
15 (10)
0
Cough
10 (7)
0
11 (7)
0
10 (7)
0
Headache
10 (7)
0
5 (3)
0
3 (2)
0
Dry skin
9 (6)
0
5 (3)
0
6 (4)
0
Myalgia
9 (6)
0
7 (4)
0
5 (3)
0
Constipation
8 (5)
0
5 (3)
0
4 (3)
0
Anemia
8 (5)
0
9 (6)
0
9 (6)
4 (3)
Asthenia
7 (5)
0
8 (5)
1 (1)
4 (3)
0
Dry mouth
7 (5)
0
3 (2)
0
5 (3)
0
Dermatitis acneiform
7 (5)
0
1 (1)
0
2 (1)
0
Chills
7 (5)
0
5 (3)
0
1 (1)
0
Pyrexia
6 (4)
0
16 (10)
0
4 (3)
0
Dyspnea
6 (4)
0
10 (6)
3 (2)
8 (5)
0
Increased blood creatinine
5 (3)
0
10 (6)
0
5 (3)
1 (1)
Arthralgia
5 (3)
0
7 (4)
0
9 (6)
0
Vomiting
4 (3)
0
11 (7)
0
7 (5)
0
E U R O P E A N U R O L O G Y 7 2 ( 2 0 1 7 ) 3 6 8 – 3 7 6
373