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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.