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Table 2 Summary of adverse events

From: Activity of dalotuzumab, a selective anti-IGF1R antibody, in combination with erlotinib in unselected patients with Non-small-cell lung cancer: a phase I/II randomized trial

Event

Phase I

Phase II

Dalotuzumab 5mg/kg plus erlotinib

Dalotuzumab 10 mg/kg plus erlotinib

Erlotinib

Dalotuzumab 10 mg/kg plus erlotinib

N = 4

N = 16

N = 38

N = 37

Diarrhea

     
 

AE

1 (25%)

12 (75%)

27 (71%)

30 (81.1%)

 

SAE

0

2 (12.6%)

0

0

 

Drug-related AE

1 (25%)

10 (62.5%)

18 (47.3%)

16 (43.2%)

 

g3-5

0

2 (12.5%)

1 (2.6%)

3 (8.1%)

Nausea

     
 

AE

0

5 (31.2%)

17 (44.7%)

17 (45.9%)

 

SAE

0

0

0

0

 

Drug-related AE

0

3 (18.7%)

4 (10.5%)

6 (16.2%)

 

g3-5

0

0

0

0

Stomatitis

     
 

AE

2 (50%)

5 (31.2%)

3 (7.9%)

4 (10.8%)

 

SAE

0

0

0

0

 

Drug-related AE

1 (25%)

3 (18.5%)

2 (5.3%)

3 (8.1%)

 

g3-5

0

0

0

0

Asthenia

     
 

AE

1 (25%)

10 (62.5%)

14 (36.8%)

14 (37.8%)

 

SAE

0

0

1 (2.6%)

0

 

Drug-related AE

0

1 (6.2%)

7 (18.4%)

3 (8.1%)

 

g3-5

0

1 (6.2%)

2 (5.3%)

2 (5.4%)

Hepatobiliary disorders

     
 

AE

0

0

4 (10.5%)

4 (10.8%)

 

SAE

0

0

0

2 (5.4%)

 

Drug-related AE

0

0

1 (2.6%)

0

 

g3-5

0

0

0

2 (5.4%)

Hyperglycemia

     
 

AE

0

8 (50%)

5 (13.1%)

7 (18.9%)

 

SAE

0

1 (6.2%)

1 (2.6%)

2 (5.4%)

 

Drug-related AE

0

2 (12.5%)

2 (5.3%)

4 (10.8%)

 

g3-5

0

5 (31.2%)

4 (10.5%)

4 (10.8%)

Dehydration

     
 

AE

0

0

2 (5.3%)

1 (2.7%)

 

SAE

0

0

1 (2.6%)

0

 

Drug-related AE

0

0

0

1 (2.7%)

 

g3-5

0

0

1 (2.6%)

0

Rash

     
 

AE

1 (25%)

9 (56.2%)

24 (63.1%)

28 (75.7%)

 

SAE*

3 (75%)

14 (87.5%)

28 (73.7%)

25 (67.6%)

 

Drug-related AE

1 (25%)

8 (50%)

19 (50%)

20 (54%)

 

g3-5

1 (25%)

0

2 (5.26%)

2 (5.4%)

Acneiform dermatitis

     
 

AE

2 (50%)

8 (50%)

11 (28.9%)

4 (10.8%)

 

SAE*

3 (75%)

14 (87.5%)

28 (73.7%)

25 (67.6%)

 

Drug-related AE

2 (50%)

6 (37.5%)

9 (23.7%)

3 (8.1%)

 

g3-5

0

0

1 (2.6%)

0

Paronychia

     
 

AE

1 (25%)

1 (6.2%)

8 (21.05%)

6 (16.2%)

 

SAE

0

0

0

0

 

Drug-related AE

0

1 (6.2%)

5 (13.1%)

4 (10.8%)

 

g3-5

0

0

0

0

Related deaths

 

0

0

1 (2.6%)**

0

Treatment discontinuations***

 

0

1 (6.25%)

2 (5.26%)

1 (2.7%)

  1. N, number of patients; AE, adverse event; SAE serious adverse event; g 3-5, grade 3 to 5 according to National Cancer Institute Common Terminology Criteria for Adverse Events.
  2. *The information on SAE related to the skin is collected together.
  3. **One patient presented with Interstitial Lung Disease and died despite discontinuing erlotinib.
  4. ***Includes only discontinuations due to drug-related SAEs.
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Experimental Hematology & Oncology

ISSN: 2162-3619

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