Table 2 Adverse events occurring in ganetespib and control arms; Grade 3/4 observed in ≥2% of participants or Grade 1/2 ≥ 20% of participants; dose reductions and early discontinuations (number, % of participants in arm/treatment phase).
Ganetespib (n = 93) | Control (n = 140) | |||
|---|---|---|---|---|
Adverse event | Grade 1–2 | Grade 3–4 | Grade 1–2 | Grade 3–4 |
Neutrophil count (decrease) | 6 (6.5%) | 20 (21.5%) | 9 (6.4%) | 14 (10.0%) |
White blood cell count (decrease) | 5 (5.4%) | 9 (9.7%) | 7 (5.0%) | 7 (5.0%) |
Diarrhea | 67 (72.0%) | 8 (8.6%) | 56 (40.0%) | 3 (2.1%) |
Peripheral sensory neuropathy | 59 (63.4%) | 8 (8.6%) | 90 (64.3%) | 2 (1.4%) |
Anemia | 22 (23.7%) | 5 (5.4%) | 19 (13.6%) | 9 (6.4%) |
Alanine aminotransferase (increase) | 7 (7.5%) | 5 (5.4%) | 11 (7.9%) | 3 (2.1%) |
Febrile neutropenia | 0 (0.0%) | 3 (3.2%) | 0 (0.0%) | 12 (8.6%) |
Stomatitis | 33 (35.5%) | 3 (3.2%) | 43 (30.7%) | 3 (2.1%) |
Fatigue | 77 (82.8%) | 3 (3.2%) | 122 (87.1%) | 1 (0.7%) |
Headache | 43 (46.2%) | 3 (3.2%) | 61 (43.6%) | 1 (0.7%) |
Neutropenia | 2 (2.2%) | 2 (2.2%) | 1 (0.7%) | 2 (1.4%) |
Vomiting | 28 (30.1%) | 2 (2.2%) | 26 (18.6%) | 0 (0.0%) |
Arthralgia | 33 (35.5%) | 2 (2.2%) | 35 (25.0%) | 1 (0.7%) |
Pulmonary embolism | 0 (0.0%) | 2 (2.2%) | 0 (0.0%) | 0 (0.0%) |
Embolism | 2 (2.2%) | 2 (2.2%) | 1 (0.7%) | 0 (0.0%) |
Nausea | 72 (77.4%) | 1 (1.1%) | 106 (75.7%) | 0 (0.0%) |
Pain | 19 (20.4%) | 1 (1.1%) | 18 (12.9%) | 1 (0.7%) |
Lymphocyte count (decrease) | 3 (3.2%) | 1 (1.1%) | 3 (2.1%) | 3 (2.1%) |
Anorexia | 30 (32.3%) | 1 (1.1%) | 30 (21.4%) | 0 (0.0%) |
Myalgia | 25 (26.9%) | 1 (1.1%) | 36 (25.7%) | 1 (0.7%) |
Anxiety | 10 (10.8%) | 1 (1.1%) | 36 (25.7%) | 0 (0.0%) |
Cough | 22 (23.7%) | 1 (1.1%) | 35 (25.0%) | 0 (0.0%) |
Hypokalaemia | 3 (3.2%) | 0 (0.0%) | 10 (7.1%) | 4 (2.9%) |
Bone pain | 18 (19.4%) | 0 (0.0%) | 41 (29.3%) | 3 (2.1%) |
Pruritus | 12 (12.9%) | 0 (0.0%) | 17 (12.1%) | 1 (0.7%) |
Alopecia | 66 (71.0%) | 0 (0.0%) | 106 (75.7%) | 0 (0.0%) |
Constipation | 53 (57.0%) | 0 (0.0%) | 74 (52.9%) | 0 (0.0%) |
Insomnia | 35 (37.6%) | 0 (0.0%) | 55 (39.3%) | 0 (0.0%) |
Hot flush | 32 (34.4%) | 0 (0.0%) | 57 (40.7%) | 0 (0.0%) |
Vision blurred | 25 (26.9%) | 0 (0.0%) | 15 (10.7%) | 0 (0.0%) |
Dysgeusia | 24 (25.8%) | 0 (0.0%) | 30 (21.4%) | 0 (0.0%) |
Dermatitis acneiform | 24 (25.8%) | 0 (0.0%) | 28 (20.0%) | 0 (0.0%) |
Dyspnea | 23 (24.7%) | 0 (0.0%) | 30 (21.4%) | 0 (0.0%) |
Nail discolouration | 22 (23.7%) | 0 (0.0%) | 30 (21.4%) | 0 (0.0%) |
Rash maculo-papular | 20 (21.5%) | 0 (0.0%) | 29 (20.7%) | 0 (0.0%) |
Gastrooesophageal reflux disease | 18 (19.4%) | 0 (0.0%) | 30 (21.4%) | 0 (0.0%) |
Dose reductions, n (%) | 16 (17.2%) | 11 (7.9%) | ||
Early discontinuation, n (%) | 37 (39.8%) | 33 (23.6%) | ||
Toxicity | 15 (16.2%) | 10 (7.1%) | ||
Progression | 12 (12.9%) | 10 (7.1%) | ||
Other | 10 (10.8%) | 13 (9.3%) | ||
Time from treatment consent to surgery (days) | ||||
Median (range) | 165 (71–250) | 165 (100–289) | ||
Follow-up time (years) | ||||
Median (range) | 3.4 (0.6–4.2) | 4.1 (0.5–6.5) | ||
