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Adverse events

In LUME-Lung 1, adverse events with VARGATEF® plus docetaxel were generally manageable1

The most common adverse events with VARGATEF® + docetaxel were:

AEs reported in ≥ 10% of adenocarcinoma patients in LUME-lung 12

 

VARGATEF® + docetaxel

(n=320)

n (%)

Placebo + docetaxel

(n=333)

n (%)

All grades Grade ≥3 All grades Grade ≥3
Any AE 308 (96.3) 243 (75.9) 314 (94.3) 228 (68.5)
  Diarrhoea 139 (43.4) 20 (6.3) 82 (24.6) 12 (3.6)
  Neutrophil count 131 (40.9) 116 (36.3) 135 (40.5) 116 (34.8)
  ALT increased 121 (37.8) 37 (11.6) 31 (9.3) 3 (0.9)
  Fatigue 99 (30.9) 15 (4.7) 98 (29.4) 14 (4.2)
  AST increased 97 (30.3) 13 (4.1) 24 (7.2) 2 (0.6)
  Nausea 91 (28.4) 3 (0.9) 59 (17.7) 2 (0.6)
  WBC decreased 89 (27.8) 63 (19.7) 94 (28.2) 61 (18.3)
  Decreased appetite 75 (23.4) 4 (1.3) 52 (15.6) 5 (1.5)
  Vomiting 62 (19.4) 4 (1.3) 41 (12.3) 2 (0.6)
  Alopecia 56 (17.5) 1 (0.3) 68 (20.4) 0 (0)
  Dyspnoea 54 (16.9) 15 (4.7) 52 (15.6) 20 (6.0)
  Neutropenia 44 (13.8) 38 (11.9) 51 (15.3) 45 (13.5)
  Cough 42 (13.1) 3 (0.9) 63 (18.9) 2 (0.6)
  Pyrexia 39 (12.2) 2 (0.6) 47 (14.1) 1 (0.3)
  Stomatitis 36 (11.3) 4 (1.3) 26 (7.8) 1 (0.3)
  Haemoglobin decreased 35 (10.9) 3 (0.9) 46 (13.8) 7 (2.1)
  Constipation 22 (6.9) 0 (0) 39 (11.7) 1 (0.3)

 

AE = adverse event;

ALT = alanine aminotransferase;

AST = aspartate aminotransferase;

WBC = white Blood Cell

 

Adverse events were classified according to Common Terminology Criteria for Adverse Events version 3.0.

 

 

References
  1. Reck M et al. Lancet Oncol 2014; 15:143–55
  2. Reck M et al. Lancet Oncol 2014; supplement published online January 9.
     http://dx.doi. org/10.1016/S1470-2045(13)70586-2
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