Table 2. Open in new tab Adverse Effects...

Adverse Event, No. (%)	Phase I Cohort (n = 55)
Any	55 (100)	16 (29)	33 (60)	2 (4)
Blood and lymphatic system disorders
Anemia	42 (76)	27 (49)	15 (27)	0 (0)
Gastrointestinal disorders
Constipation	12 (22)	12 (22)	0 (0)	0 (0)
Diarrhea	12 (22)	12 (22)	0 (0)	0 (0)
Nausea	20 (36)	19 (35)	1 (2)	0 (0)
Vomiting	16 (29)	16 (29)	0 (0)	0 (0)
General disorders and administration site conditions
Fatigue	39 (71)	36 (65)	3 (5)	0 (0)
Localized Edema	15 (27)	15 (27)	0 (0)	0 (0)
Investigations
Creatinine Increased	14 (25)	13 (24)	1 (2)	0 (0)
Hyperkalemia	12 (22)	11 (20)	1 (2)	0 (0)
Metabolism and nutrition disorders
Dehydration	11 (20)	10 (18)	1 (2)	0 (0)
Musculoskeletal and connective tissue disorders
Arthralgia	14 (25)	14 (25)	0 (0)	0 (0)
Back pain	12 (22)	11 (20)	1 (2)	0 (0)
Nervous system disorders
Dizziness	13 (24)	13 (24)	0 (0)	0 (0)
Headache	14 (25)	13 (24)	1 (2)	0 (0)
Respiratory, thoracic, and mediastinal disorders
Cough	17 (31)	17 (31)	0 (0)	0 (0)
Dyspnea	29 (49)	24 (44)	3 (5)	0 (0)
Hypoxia	17 (31)	8 (15)	9 (16)	0 (0)

Adverse Event, No. (%)

Phase I Cohort (n = 55)

MedDRA SOC, CTCAE 5.0

All

Grade 1 or 2

Grade 3

Grade 4

Any

55 (100)

16 (29)

33 (60)

2 (4)

Blood and lymphatic system disorders

Anemia

42 (76)

27 (49)

15 (27)

0 (0)

Gastrointestinal disorders

Constipation

12 (22)

0 (0)

Diarrhea

12 (22)

0 (0)

Nausea

20 (36)

19 (35)

1 (2)

0 (0)

Vomiting

16 (29)

0 (0)

General disorders and administration site conditions

Fatigue

39 (71)

36 (65)

3 (5)

0 (0)

Localized Edema

15 (27)

0 (0)

Investigations

Creatinine Increased

14 (25)

13 (24)

1 (2)

0 (0)

Hyperkalemia

12 (22)

11 (20)

1 (2)

0 (0)

Metabolism and nutrition disorders

Dehydration

11 (20)

10 (18)

1 (2)

0 (0)

Musculoskeletal and connective tissue disorders

Arthralgia

14 (25)

0 (0)

Back pain

12 (22)

11 (20)

1 (2)

0 (0)

Nervous system disorders

Dizziness

13 (24)

0 (0)

Headache

14 (25)

13 (24)

1 (2)

0 (0)

Respiratory, thoracic, and mediastinal disorders

Cough

17 (31)

0 (0)

Dyspnea

29 (49)

24 (44)

3 (5)

0 (0)

Hypoxia

17 (31)

8 (15)

9 (16)

0 (0)

Adverse Event, No. (%)	Phase I Cohort (n = 55)
Any	55 (100)	16 (29)	33 (60)	2 (4)
Blood and lymphatic system disorders
Anemia	42 (76)	27 (49)	15 (27)	0 (0)
Gastrointestinal disorders
Constipation	12 (22)	12 (22)	0 (0)	0 (0)
Diarrhea	12 (22)	12 (22)	0 (0)	0 (0)
Nausea	20 (36)	19 (35)	1 (2)	0 (0)
Vomiting	16 (29)	16 (29)	0 (0)	0 (0)
General disorders and administration site conditions
Fatigue	39 (71)	36 (65)	3 (5)	0 (0)
Localized Edema	15 (27)	15 (27)	0 (0)	0 (0)
Investigations
Creatinine Increased	14 (25)	13 (24)	1 (2)	0 (0)
Hyperkalemia	12 (22)	11 (20)	1 (2)	0 (0)
Metabolism and nutrition disorders
Dehydration	11 (20)	10 (18)	1 (2)	0 (0)
Musculoskeletal and connective tissue disorders
Arthralgia	14 (25)	14 (25)	0 (0)	0 (0)
Back pain	12 (22)	11 (20)	1 (2)	0 (0)
Nervous system disorders
Dizziness	13 (24)	13 (24)	0 (0)	0 (0)
Headache	14 (25)	13 (24)	1 (2)	0 (0)
Respiratory, thoracic, and mediastinal disorders
Cough	17 (31)	17 (31)	0 (0)	0 (0)
Dyspnea	29 (49)	24 (44)	3 (5)	0 (0)
Hypoxia	17 (31)	8 (15)	9 (16)	0 (0)

Adverse Event, no. (%)	Phase II cohort (n = 61)
Any	61 (100)	N/A	N/A	9 (15)	1 (2)
Blood and lymphatic system disorders
Anemia	55 (90)	24 (39)	26 (43)	5 (8)	0 (0)
Gastrointestinal disorders
Nausea	21 (34)	15 (25)	6 (10)	0 (0)	0 (0)
Constipation	12 (20)	10 (16)	2 (3)	0 (0)	0 (0)
General disorders and administration site conditions
Fatigue	40 (66)	29 (48)	8 (13)	3 (5)	0 (0)
Musculoskeletal and connective tissue disorders
Arthralgia	12 (20)	10 (16)	2 (3)	0 (0)	0 (0)
Myalgia	12 (20)	9 (15)	2 (3)	1 (2)	0 (0)
Nervous system disorders
Headache	25 (41)	20 (33)	5 (8)	0 (0)	0 (0)
Dizziness	24 (39)	20 (33)	4 (7)	0 (0)	0 (0)
Respiratory, thoracic, and mediastinal disorders
Dyspnea	14 (23)	13 (21)	0 (0)	1 (2)	0 (0)

Adverse Event, no. (%)

Phase II cohort (n = 61)

MedDRA SOC, CTCAE 5.0

All

Grade 1

Grade 2

Grade 3

Grade 4

Any

61 (100)

N/A

9 (15)

1 (2)

Blood and lymphatic system disorders

Anemia

55 (90)

24 (39)

26 (43)

5 (8)

0 (0)

Gastrointestinal disorders

Nausea

21 (34)

15 (25)

6 (10)

0 (0)

Constipation

12 (20)

10 (16)

2 (3)

0 (0)

General disorders and administration site conditions

Fatigue

40 (66)

29 (48)

8 (13)

3 (5)

0 (0)

Musculoskeletal and connective tissue disorders

Arthralgia

12 (20)

10 (16)

2 (3)

0 (0)

Myalgia

12 (20)

9 (15)

2 (3)

1 (2)

0 (0)

Nervous system disorders

Headache

25 (41)

20 (33)

5 (8)

0 (0)

Dizziness

24 (39)

20 (33)

4 (7)

0 (0)

Respiratory, thoracic, and mediastinal disorders

Dyspnea

14 (23)

13 (21)

0 (0)

1 (2)

0 (0)

Adverse Event, no. (%)	Phase II cohort (n = 61)
Any	61 (100)	N/A	N/A	9 (15)	1 (2)
Blood and lymphatic system disorders
Anemia	55 (90)	24 (39)	26 (43)	5 (8)	0 (0)
Gastrointestinal disorders
Nausea	21 (34)	15 (25)	6 (10)	0 (0)	0 (0)
Constipation	12 (20)	10 (16)	2 (3)	0 (0)	0 (0)
General disorders and administration site conditions
Fatigue	40 (66)	29 (48)	8 (13)	3 (5)	0 (0)
Musculoskeletal and connective tissue disorders
Arthralgia	12 (20)	10 (16)	2 (3)	0 (0)	0 (0)
Myalgia	12 (20)	9 (15)	2 (3)	1 (2)	0 (0)
Nervous system disorders
Headache	25 (41)	20 (33)	5 (8)	0 (0)	0 (0)
Dizziness	24 (39)	20 (33)	4 (7)	0 (0)	0 (0)
Respiratory, thoracic, and mediastinal disorders
Dyspnea	14 (23)	13 (21)	0 (0)	1 (2)	0 (0)

Table 2.

Open in new tab

Adverse Effects of Belzutifan in Phase I and II Trials

Adverse Event, No. (%)	Phase I Cohort (n = 55)
MedDRA SOC, CTCAE 5.0	All	Grade 1 or 2	Grade 3	Grade 4
Any	55 (100)	16 (29)	33 (60)	2 (4)
Blood and lymphatic system disorders
Anemia	42 (76)	27 (49)	15 (27)	0 (0)
Gastrointestinal disorders
Constipation	12 (22)	12 (22)	0 (0)	0 (0)
Diarrhea	12 (22)	12 (22)	0 (0)	0 (0)
Nausea	20 (36)	19 (35)	1 (2)	0 (0)
Vomiting	16 (29)	16 (29)	0 (0)	0 (0)
General disorders and administration site conditions
Fatigue	39 (71)	36 (65)	3 (5)	0 (0)
Localized Edema	15 (27)	15 (27)	0 (0)	0 (0)
Investigations
Creatinine Increased	14 (25)	13 (24)	1 (2)	0 (0)
Hyperkalemia	12 (22)	11 (20)	1 (2)	0 (0)
Metabolism and nutrition disorders
Dehydration	11 (20)	10 (18)	1 (2)	0 (0)
Musculoskeletal and connective tissue disorders
Arthralgia	14 (25)	14 (25)	0 (0)	0 (0)
Back pain	12 (22)	11 (20)	1 (2)	0 (0)
Nervous system disorders
Dizziness	13 (24)	13 (24)	0 (0)	0 (0)
Headache	14 (25)	13 (24)	1 (2)	0 (0)
Respiratory, thoracic, and mediastinal disorders
Cough	17 (31)	17 (31)	0 (0)	0 (0)
Dyspnea	29 (49)	24 (44)	3 (5)	0 (0)
Hypoxia	17 (31)	8 (15)	9 (16)	0 (0)

Adverse Event, No. (%)	Phase I Cohort (n = 55)
MedDRA SOC, CTCAE 5.0	All	Grade 1 or 2	Grade 3	Grade 4
Any	55 (100)	16 (29)	33 (60)	2 (4)
Blood and lymphatic system disorders
Anemia	42 (76)	27 (49)	15 (27)	0 (0)
Gastrointestinal disorders
Constipation	12 (22)	12 (22)	0 (0)	0 (0)
Diarrhea	12 (22)	12 (22)	0 (0)	0 (0)
Nausea	20 (36)	19 (35)	1 (2)	0 (0)
Vomiting	16 (29)	16 (29)	0 (0)	0 (0)
General disorders and administration site conditions
Fatigue	39 (71)	36 (65)	3 (5)	0 (0)
Localized Edema	15 (27)	15 (27)	0 (0)	0 (0)
Investigations
Creatinine Increased	14 (25)	13 (24)	1 (2)	0 (0)
Hyperkalemia	12 (22)	11 (20)	1 (2)	0 (0)
Metabolism and nutrition disorders
Dehydration	11 (20)	10 (18)	1 (2)	0 (0)
Musculoskeletal and connective tissue disorders
Arthralgia	14 (25)	14 (25)	0 (0)	0 (0)
Back pain	12 (22)	11 (20)	1 (2)	0 (0)
Nervous system disorders
Dizziness	13 (24)	13 (24)	0 (0)	0 (0)
Headache	14 (25)	13 (24)	1 (2)	0 (0)
Respiratory, thoracic, and mediastinal disorders
Cough	17 (31)	17 (31)	0 (0)	0 (0)
Dyspnea	29 (49)	24 (44)	3 (5)	0 (0)
Hypoxia	17 (31)	8 (15)	9 (16)	0 (0)

Adverse Event, no. (%)	Phase II cohort (n = 61)
MedDRA SOC, CTCAE 5.0	All	Grade 1	Grade 2	Grade 3	Grade 4
Any	61 (100)	N/A	N/A	9 (15)	1 (2)
Blood and lymphatic system disorders
Anemia	55 (90)	24 (39)	26 (43)	5 (8)	0 (0)
Gastrointestinal disorders
Nausea	21 (34)	15 (25)	6 (10)	0 (0)	0 (0)
Constipation	12 (20)	10 (16)	2 (3)	0 (0)	0 (0)
General disorders and administration site conditions
Fatigue	40 (66)	29 (48)	8 (13)	3 (5)	0 (0)
Musculoskeletal and connective tissue disorders
Arthralgia	12 (20)	10 (16)	2 (3)	0 (0)	0 (0)
Myalgia	12 (20)	9 (15)	2 (3)	1 (2)	0 (0)
Nervous system disorders
Headache	25 (41)	20 (33)	5 (8)	0 (0)	0 (0)
Dizziness	24 (39)	20 (33)	4 (7)	0 (0)	0 (0)
Respiratory, thoracic, and mediastinal disorders
Dyspnea	14 (23)	13 (21)	0 (0)	1 (2)	0 (0)

Adverse Event, no. (%)	Phase II cohort (n = 61)
MedDRA SOC, CTCAE 5.0	All	Grade 1	Grade 2	Grade 3	Grade 4
Any	61 (100)	N/A	N/A	9 (15)	1 (2)
Blood and lymphatic system disorders
Anemia	55 (90)	24 (39)	26 (43)	5 (8)	0 (0)
Gastrointestinal disorders
Nausea	21 (34)	15 (25)	6 (10)	0 (0)	0 (0)
Constipation	12 (20)	10 (16)	2 (3)	0 (0)	0 (0)
General disorders and administration site conditions
Fatigue	40 (66)	29 (48)	8 (13)	3 (5)	0 (0)
Musculoskeletal and connective tissue disorders
Arthralgia	12 (20)	10 (16)	2 (3)	0 (0)	0 (0)
Myalgia	12 (20)	9 (15)	2 (3)	1 (2)	0 (0)
Nervous system disorders
Headache	25 (41)	20 (33)	5 (8)	0 (0)	0 (0)
Dizziness	24 (39)	20 (33)	4 (7)	0 (0)	0 (0)
Respiratory, thoracic, and mediastinal disorders
Dyspnea	14 (23)	13 (21)	0 (0)	1 (2)	0 (0)

The adverse effects of belzutifan were obtained from the phase I and phase II trials. Adverse events affecting 20% or more of the study participants are listed here. They were categorized according to CTCAE 5.0 MedDRA SOC and converted into CTCAE terms. The adverse events were categorized from grades 1–4 and presented as the number of individuals and percent of the total. There were no grade 5 adverse events. The most common adverse event was anemia, which occurred in 76% of patients in the phase I trial and 90% of the patients in the phase II trial.

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