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Table 4 Treatment emergent adverse events occurring in 5 or more patients and relationships* to study drug treatment

From: Survival with AGS-003, an autologous dendritic cell–based immunotherapy, in combination with sunitinib in unfavorable risk patients with advanced renal cell carcinoma (RCC): Phase 2 study results

Adverse event

Treatment-Emergent adverse events

N = 22

Number of patients (%)

All

AGS-003 related**

Sunitinib related

Combination related

Any

22 (100)

17 (77)

22 (100)

12 (55)

Diarrhea

13 (59)

3 (14)

11 (50)

3 (14)

Fatigue

13 (59)

3 (14)

12 (55)

2 (9)

Nausea

12 (55)

2 (9)

11 (50)

2 (9)

Rash

10 (46)

4 (18)

9 (41)

5 (23)

Decreased weight

9 (41)

1 (5)

5 (23)

1 (5)

Headache

8 (36)

2 (9)

4 (18)

2 (9)

Injection-site erythema

8 (36)

7 (32)

0

0

Peripheral edema

8 (36)

0

4 (18)

0

Dyspnea

7 (32)

0

1 (5)

0

Vomiting

7 (32)

0

7 (32)

0

Anorexia

6 (27)

0

5 (23)

1 (5)

Hypertension

6 (27)

1 (5)

6 (27)

1 (5)

Hypothyroidism

6 (27)

0

5 (23)

1 (5)

Hand-foot syndrome

6 (27)

0

6 (27)

0

Constipation

5 (23)

0

2 (9)

0

Dehydration

5 (23)

0

2 (9)

0

Dysgeusia

5 (23)

1 (5)

5 (23)

1 (5)

Injection-site induration

5 (23)

5 (23)

0

1 (5)

  1. *Events described as possible, probably or definitely related to study drug.
  2. **All AGS-003 related events were Grade 1 or 2 in severity.