Table 5. Open in new tab...

All grades/≥3 Grade, %	Overall study population	Japan	North America	European Union
Non-hematologic adverse events
Nausea	47/4	37/3	58/2	46/5	45/8	36/2	41/4	37/1
Fatigue	42/9	37/7	70/9	46/9	49/13	53/11	26/6	25/5
Anorexia	37/6	27/4	68/16	52/4	33/5	21/5	24/4	22/3
Diarrhea	33/1	22/2	39/2	16/0	27/1	26/1	29/0	25/2
Vomiting	32/4	33/3	39/0	34/0	28/5	40/4	33/6	32/4
Constipation	29/1	31/2	49/0	41/4	24/3	38/4	21/0	22/1
Hypertension	28/7	9/2	44/12	4/2	31/7	14/5	23/5	10/0
Dysphonia	22/<1	4/0	60/2	18/0	17/0	2/0	10/0	0
Abdominal pain	21/7	19/6	7/2	4/0	24/9	25/10	24/8	22/5
Stomatitis	17/0	4/<1	46/0	2/0	12/0	2/1	8/0	6/0
Pyrexia	16/1	16/<1	23/0	20/0	12/1	23/0	18/2	11/1
Rash	14/1	14/1	21/0	32/2	8/1	16/1	13/1	7/1
Asthenia	14/5	13/2	0	0	12/11	12/2	23/6	21/3
Weight decreased	14/<1	10/<1	21/0	11/2	9/0	16/0	14/1	10/0
Alopecia	10/0	6/0	25/0	11/0	1/0	5/0	7/0	6/0
Dyspnea	9/2	8/3	0	7/2	20/7	12/5	8/0	8/3
Edema peripheral	8/0	16/1	2/0	11/2	13/0	33/0	6/0	9/0
Hand–foot syndrome	6/<1	1/0	25/2	2/0	0	0	2/0	1/0
Hematologic abnormalities
Neutropenia^a	24 /17	18/11	9/7	7/5	21/15	20/12	25/17	17/11
Thrombocytopenia^b	16/5	12/3	0	0	27/9	21/7	11/2	13/2
Platelet count decreased^b	14/4	13/4	51/14	38/13	11/4	14/4	2/0	4/0
Neutrophil count decreased^a	10/7	13/9	42/32	50/39	8/3	7/5	1/1	4/2
Anemia^c	9/1	18/3	0	0	12/3	27/5	10/0	23/2
White blood cell count decreased	7/1	5/1	30/4	21/7	1/1	1/0	1/1	0
Hemoglobin decreased^c	6/1	9/2	21/2	23/2	7/3	11/2	0	4/1

All grades/≥3 Grade, %

Overall study population

Japan

North America

European Union

Axitinib/ Gem (n = 305)

Placebo/ Gem (n = 308)

Axitinib/ Gem (n = 57)

Placebo/ Gem (n = 56)

Axitinib/ Gem (n = 75)

Placebo/ Gem (n = 81)

Axitinib/ Gem (n = 127)

Placebo/ Gem (n = 126)

Non-hematologic adverse events

Nausea

47/4

37/3

58/2

46/5

45/8

36/2

41/4

37/1

Fatigue

42/9

37/7

70/9

46/9

49/13

53/11

26/6

25/5

Anorexia

37/6

27/4

68/16

52/4

33/5

21/5

24/4

22/3

Diarrhea

33/1

22/2

39/2

16/0

27/1

26/1

29/0

25/2

Vomiting

32/4

33/3

39/0

34/0

28/5

40/4

33/6

32/4

Constipation

29/1

31/2

49/0

41/4

24/3

38/4

21/0

22/1

Hypertension

28/7

9/2

44/12

4/2

31/7

14/5

23/5

10/0

Dysphonia

22/<1

4/0

60/2

18/0

17/0

2/0

10/0

Abdominal pain

21/7

19/6

7/2

4/0

24/9

25/10

24/8

22/5

Stomatitis

17/0

4/<1

46/0

2/0

12/0

2/1

8/0

6/0

Pyrexia

16/1

16/<1

23/0

20/0

12/1

23/0

18/2

11/1

Rash

14/1

21/0

32/2

8/1

16/1

13/1

7/1

Asthenia

14/5

13/2

12/11

12/2

23/6

21/3

Weight decreased

14/<1

10/<1

21/0

11/2

9/0

16/0

14/1

10/0

Alopecia

10/0

6/0

25/0

11/0

1/0

5/0

7/0

6/0

Dyspnea

9/2

8/3

7/2

20/7

12/5

8/0

8/3

Edema peripheral

8/0

16/1

2/0

11/2

13/0

33/0

6/0

9/0

Hand–foot syndrome

6/<1

1/0

25/2

2/0

1/0

Hematologic abnormalities

Neutropenia^a

24 /17

18/11

9/7

7/5

21/15

20/12

25/17

17/11

Thrombocytopenia^b

16/5

12/3

27/9

21/7

11/2

13/2

Platelet count decreased^b

14/4

13/4

51/14

38/13

11/4

14/4

2/0

4/0

Neutrophil count decreased^a

10/7

13/9

42/32

50/39

8/3

7/5

1/1

4/2

Anemia^c

9/1

18/3

12/3

27/5

10/0

23/2

White blood cell count decreased

7/1

5/1

30/4

21/7

1/1

1/0

1/1

Hemoglobin decreased^c

6/1

9/2

21/2

23/2

7/3

11/2

4/1

All grades/≥3 Grade, %	Overall study population	Japan	North America	European Union
Non-hematologic adverse events
Nausea	47/4	37/3	58/2	46/5	45/8	36/2	41/4	37/1
Fatigue	42/9	37/7	70/9	46/9	49/13	53/11	26/6	25/5
Anorexia	37/6	27/4	68/16	52/4	33/5	21/5	24/4	22/3
Diarrhea	33/1	22/2	39/2	16/0	27/1	26/1	29/0	25/2
Vomiting	32/4	33/3	39/0	34/0	28/5	40/4	33/6	32/4
Constipation	29/1	31/2	49/0	41/4	24/3	38/4	21/0	22/1
Hypertension	28/7	9/2	44/12	4/2	31/7	14/5	23/5	10/0
Dysphonia	22/<1	4/0	60/2	18/0	17/0	2/0	10/0	0
Abdominal pain	21/7	19/6	7/2	4/0	24/9	25/10	24/8	22/5
Stomatitis	17/0	4/<1	46/0	2/0	12/0	2/1	8/0	6/0
Pyrexia	16/1	16/<1	23/0	20/0	12/1	23/0	18/2	11/1
Rash	14/1	14/1	21/0	32/2	8/1	16/1	13/1	7/1
Asthenia	14/5	13/2	0	0	12/11	12/2	23/6	21/3
Weight decreased	14/<1	10/<1	21/0	11/2	9/0	16/0	14/1	10/0
Alopecia	10/0	6/0	25/0	11/0	1/0	5/0	7/0	6/0
Dyspnea	9/2	8/3	0	7/2	20/7	12/5	8/0	8/3
Edema peripheral	8/0	16/1	2/0	11/2	13/0	33/0	6/0	9/0
Hand–foot syndrome	6/<1	1/0	25/2	2/0	0	0	2/0	1/0
Hematologic abnormalities
Neutropenia^a	24 /17	18/11	9/7	7/5	21/15	20/12	25/17	17/11
Thrombocytopenia^b	16/5	12/3	0	0	27/9	21/7	11/2	13/2
Platelet count decreased^b	14/4	13/4	51/14	38/13	11/4	14/4	2/0	4/0
Neutrophil count decreased^a	10/7	13/9	42/32	50/39	8/3	7/5	1/1	4/2
Anemia^c	9/1	18/3	0	0	12/3	27/5	10/0	23/2
White blood cell count decreased	7/1	5/1	30/4	21/7	1/1	1/0	1/1	0
Hemoglobin decreased^c	6/1	9/2	21/2	23/2	7/3	11/2	0	4/1

Table 5.

Open in new tab

Treatment-emergent, all-causality adverse events reported by >20% of patients in any arm in any region

All grades/≥3 Grade, %	Overall study population		Japan		North America		European Union
All grades/≥3 Grade, %	Axitinib/ Gem (n = 305)	Placebo/ Gem (n = 308)	Axitinib/ Gem (n = 57)	Placebo/ Gem (n = 56)	Axitinib/ Gem (n = 75)	Placebo/ Gem (n = 81)	Axitinib/ Gem (n = 127)	Placebo/ Gem (n = 126)
Non-hematologic adverse events
Nausea	47/4	37/3	58/2	46/5	45/8	36/2	41/4	37/1
Fatigue	42/9	37/7	70/9	46/9	49/13	53/11	26/6	25/5
Anorexia	37/6	27/4	68/16	52/4	33/5	21/5	24/4	22/3
Diarrhea	33/1	22/2	39/2	16/0	27/1	26/1	29/0	25/2
Vomiting	32/4	33/3	39/0	34/0	28/5	40/4	33/6	32/4
Constipation	29/1	31/2	49/0	41/4	24/3	38/4	21/0	22/1
Hypertension	28/7	9/2	44/12	4/2	31/7	14/5	23/5	10/0
Dysphonia	22/<1	4/0	60/2	18/0	17/0	2/0	10/0	0
Abdominal pain	21/7	19/6	7/2	4/0	24/9	25/10	24/8	22/5
Stomatitis	17/0	4/<1	46/0	2/0	12/0	2/1	8/0	6/0
Pyrexia	16/1	16/<1	23/0	20/0	12/1	23/0	18/2	11/1
Rash	14/1	14/1	21/0	32/2	8/1	16/1	13/1	7/1
Asthenia	14/5	13/2	0	0	12/11	12/2	23/6	21/3
Weight decreased	14/<1	10/<1	21/0	11/2	9/0	16/0	14/1	10/0
Alopecia	10/0	6/0	25/0	11/0	1/0	5/0	7/0	6/0
Dyspnea	9/2	8/3	0	7/2	20/7	12/5	8/0	8/3
Edema peripheral	8/0	16/1	2/0	11/2	13/0	33/0	6/0	9/0
Hand–foot syndrome	6/<1	1/0	25/2	2/0	0	0	2/0	1/0
Hematologic abnormalities
Neutropenia^a	24 /17	18/11	9/7	7/5	21/15	20/12	25/17	17/11
Thrombocytopenia^b	16/5	12/3	0	0	27/9	21/7	11/2	13/2
Platelet count decreased^b	14/4	13/4	51/14	38/13	11/4	14/4	2/0	4/0
Neutrophil count decreased^a	10/7	13/9	42/32	50/39	8/3	7/5	1/1	4/2
Anemia^c	9/1	18/3	0	0	12/3	27/5	10/0	23/2
White blood cell count decreased	7/1	5/1	30/4	21/7	1/1	1/0	1/1	0
Hemoglobin decreased^c	6/1	9/2	21/2	23/2	7/3	11/2	0	4/1

All grades/≥3 Grade, %	Overall study population		Japan		North America		European Union
All grades/≥3 Grade, %	Axitinib/ Gem (n = 305)	Placebo/ Gem (n = 308)	Axitinib/ Gem (n = 57)	Placebo/ Gem (n = 56)	Axitinib/ Gem (n = 75)	Placebo/ Gem (n = 81)	Axitinib/ Gem (n = 127)	Placebo/ Gem (n = 126)
Non-hematologic adverse events
Nausea	47/4	37/3	58/2	46/5	45/8	36/2	41/4	37/1
Fatigue	42/9	37/7	70/9	46/9	49/13	53/11	26/6	25/5
Anorexia	37/6	27/4	68/16	52/4	33/5	21/5	24/4	22/3
Diarrhea	33/1	22/2	39/2	16/0	27/1	26/1	29/0	25/2
Vomiting	32/4	33/3	39/0	34/0	28/5	40/4	33/6	32/4
Constipation	29/1	31/2	49/0	41/4	24/3	38/4	21/0	22/1
Hypertension	28/7	9/2	44/12	4/2	31/7	14/5	23/5	10/0
Dysphonia	22/<1	4/0	60/2	18/0	17/0	2/0	10/0	0
Abdominal pain	21/7	19/6	7/2	4/0	24/9	25/10	24/8	22/5
Stomatitis	17/0	4/<1	46/0	2/0	12/0	2/1	8/0	6/0
Pyrexia	16/1	16/<1	23/0	20/0	12/1	23/0	18/2	11/1
Rash	14/1	14/1	21/0	32/2	8/1	16/1	13/1	7/1
Asthenia	14/5	13/2	0	0	12/11	12/2	23/6	21/3
Weight decreased	14/<1	10/<1	21/0	11/2	9/0	16/0	14/1	10/0
Alopecia	10/0	6/0	25/0	11/0	1/0	5/0	7/0	6/0
Dyspnea	9/2	8/3	0	7/2	20/7	12/5	8/0	8/3
Edema peripheral	8/0	16/1	2/0	11/2	13/0	33/0	6/0	9/0
Hand–foot syndrome	6/<1	1/0	25/2	2/0	0	0	2/0	1/0
Hematologic abnormalities
Neutropenia^a	24 /17	18/11	9/7	7/5	21/15	20/12	25/17	17/11
Thrombocytopenia^b	16/5	12/3	0	0	27/9	21/7	11/2	13/2
Platelet count decreased^b	14/4	13/4	51/14	38/13	11/4	14/4	2/0	4/0
Neutrophil count decreased^a	10/7	13/9	42/32	50/39	8/3	7/5	1/1	4/2
Anemia^c	9/1	18/3	0	0	12/3	27/5	10/0	23/2
White blood cell count decreased	7/1	5/1	30/4	21/7	1/1	1/0	1/1	0
Hemoglobin decreased^c	6/1	9/2	21/2	23/2	7/3	11/2	0	4/1

Gem, gemcitabine

^aUsing terminology of neutropenia or neutrophil count decreased was based on physician's discretion.

^bUsing terminology of thrombocytopenia or platelet count decreased was based on physician's discretion.

^cUsing terminology of anemia or hemoglobin decreased was based on physician's discretion.

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