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Study of Nivolumab in Unresectable Advanced or Recurrent Esophageal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02569242
Recruitment Status : Completed
First Posted : October 6, 2015
Results First Posted : January 14, 2022
Last Update Posted : July 6, 2022
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Esophageal Cancer
Interventions Drug: Nivolumab
Drug: Docetaxel/Paclitaxel
Enrollment 419
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Nivolumab Arm Active Comparator Arm （Docetaxel/Paclitaxel）
Hide Arm/Group Description Nivolumab 240 mg/body solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Docetaxel: Intravenously administered at a dose of 75 mg/m2 every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

OR

Paclitaxel: Intravenously administered at a dose of 100 mg/m2 weekly for 6 weeks followed by 2-week drug holiday until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Period Title: Overall Study
Started [1] 210 [2] 209 [2]
Completed [3] 209 [4] 208 [4]
Not Completed 1 1
Reason Not Completed
Death             1             0
Withdrawal by Subject             0             1
[1]
Enrolled and randomly assigned
[2]
Included in intention-to-treat analysis for overall survival and progression-free survival
[3]
Received assigned treatment of IMP
[4]
Analysed for safety
Arm/Group Title Nivolumab Arm Active Comparator Arm （Docetaxel/Paclitaxel） Total
Hide Arm/Group Description Nivolumab 240 mg/body solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Docetaxel: Intravenously administered at a dose of 75 mg/m2 every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

OR

Paclitaxel: Intravenously administered at a dose of 100 mg/m2 weekly for 6 weeks followed by 2-week drug holiday until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

 Total of all reporting groups
Overall Number of Baseline Participants 210 209 419
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 210 participants 209 participants 419 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
112
  53.3%
85
  40.7%
197
  47.0%
>=65 years
98
  46.7%
124
  59.3%
222
  53.0%
Age, Continuous  
Mean (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 210 participants 209 participants 419 participants
64
(57 to 69)
67
(57 to 72)
65
(57 to 71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 210 participants 209 participants 419 participants
Female
31
  14.8%
24
  11.5%
55
  13.1%
Male
179
  85.2%
185
  88.5%
364
  86.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 210 participants 209 participants 419 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
201
  95.7%
200
  95.7%
401
  95.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
9
   4.3%
9
   4.3%
18
   4.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Asian Number Analyzed 210 participants 209 participants 419 participants
201
  95.7%
200
  95.7%
401
  95.7%
White Number Analyzed 210 participants 209 participants 419 participants
9
   4.3%
9
   4.3%
18
   4.3%
ECOG performance status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
0 Number Analyzed 210 participants 209 participants 419 participants
101
  48.1%
107
  51.2%
208
  49.6%
1 Number Analyzed 210 participants 209 participants 419 participants
109
  51.9%
102
  48.8%
211
  50.4%
[1]
Measure Description: performance status 0；Fully active, able to continue all pre-disease activities without restriction performance status 1；Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work
Disease stage : TNM classification   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
II - III Number Analyzed 107 participants 120 participants 227 participants
8
   7.5%
13
  10.8%
21
   9.3%
IV Number Analyzed 107 participants 120 participants 227 participants
94
  87.9%
100
  83.3%
194
  85.5%
unknown Number Analyzed 107 participants 120 participants 227 participants
5
   4.7%
7
   5.8%
12
   5.3%
[1]
Measure Description: In this study, the TNM Classification of Malignant Tumours, Seventh Edition, published by the Union for International Cancer Control (UICC) (hereinafter referred to as "the TNM classification") will be used to determine disease stage. please refer to the protocol information. Higher numbers mean the cancer is more advanced.
[2]
Measure Analysis Population Description: Summarized for subjects with non-recurrent esophageal cancer.
Previous therapies  
Measure Type: Count of Participants
Unit of measure:  Participants
Surgery Number Analyzed 210 participants 209 participants 419 participants
111
  52.9%
94
  45.0%
205
  48.9%
Radiothrapy Number Analyzed 210 participants 209 participants 419 participants
153
  72.9%
142
  67.9%
295
  70.4%
Systemic anticancer therapy Number Analyzed 210 participants 209 participants 419 participants
210
 100.0%
208
  99.5%
418
  99.8%
Number of organs of metastases  
Measure Type: Count of Participants
Unit of measure:  Participants
<=1 Number Analyzed 210 participants 209 participants 419 participants
89
  42.4%
91
  43.5%
180
  43.0%
>=2 Number Analyzed 210 participants 209 participants 419 participants
121
  57.6%
118
  56.5%
239
  57.0%
Site of metastases  
Measure Type: Count of Participants
Unit of measure:  Participants
Lymph node Number Analyzed 210 participants 209 participants 419 participants
159
  75.7%
163
  78.0%
322
  76.8%
Liver Number Analyzed 210 participants 209 participants 419 participants
57
  27.1%
54
  25.8%
111
  26.5%
Lung Number Analyzed 210 participants 209 participants 419 participants
98
  46.7%
92
  44.0%
190
  45.3%
Bone Number Analyzed 210 participants 209 participants 419 participants
23
  11.0%
25
  12.0%
48
  11.5%
PD-L1 expression   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
<1% Number Analyzed 210 participants 209 participants 419 participants
109
  51.9%
107
  51.2%
216
  51.6%
>=1% Number Analyzed 210 participants 209 participants 419 participants
101
  48.1%
102
  48.8%
203
  48.4%
<5% Number Analyzed 210 participants 209 participants 419 participants
136
  64.8%
137
  65.6%
273
  65.2%
>=5% Number Analyzed 210 participants 209 participants 419 participants
74
  35.2%
72
  34.4%
146
  34.8%
<10% Number Analyzed 210 participants 209 participants 419 participants
146
  69.5%
152
  72.7%
298
  71.1%
>=10% Number Analyzed 210 participants 209 participants 419 participants
64
  30.5%
57
  27.3%
121
  28.9%
[1]
Measure Description: In this study, the subject will test positive for PD-L1 when cancerous cells with stained cell membranes account for ≧1% of at least 100 evaluable cancerous cells and will test negative for PD-L1 when such cells account for <1%, the same applies to 5% and 10%.
History of smoking  
Measure Type: Count of Participants
Unit of measure:  Participants
Never Number Analyzed 210 participants 209 participants 419 participants
30
  14.3%
32
  15.3%
62
  14.8%
Former Number Analyzed 210 participants 209 participants 419 participants
159
  75.7%
147
  70.3%
306
  73.0%
Current Number Analyzed 210 participants 209 participants 419 participants
21
  10.0%
30
  14.4%
51
  12.2%
1.Primary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame ("Date of death from any cause" - "Date of randomization" + 1) / 30.4375. For subjects lost to follow-up and subjects who are alive at the time of data cutoff date, data will be censored at the time the subject was last confirmed to be alive.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nivolumab Arm Active Comparator Arm （Docetaxel/Paclitaxel）
Hide Arm/Group Description:
Nivolumab 240 mg/body solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Docetaxel: Intravenously administered at a dose of 75 mg/m2 every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

OR

Paclitaxel: Intravenously administered at a dose of 100 mg/m2 weekly for 6 weeks followed by 2-week drug holiday until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Overall Number of Participants Analyzed 210 209
Median (95% Confidence Interval)
Unit of Measure: months
10.9
(9.2 to 13.3)
8.4
(7.2 to 9.9)
2.Secondary Outcome
Title Progression-free Survival
Hide Description Please refer to the protocol, overall response and best overall response will be determined solely by imaging assessment according to the RECIST Guideline Version 1.1, and will not take into account any clinical/symptomatic progression. Evaluable imaging data will be overall response without an overall response of "Not Evaluable (NE)."
Time Frame ("Earlier date on which either the overall response was assessed as PD or the subject died of any cause" - "Date of randomization" + 1) / 30.4375.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nivolumab Arm Active Comparator Arm （Docetaxel/Paclitaxel）
Hide Arm/Group Description:
Nivolumab 240 mg/body solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Docetaxel: Intravenously administered at a dose of 75 mg/m2 every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

OR

Paclitaxel: Intravenously administered at a dose of 100 mg/m2 weekly for 6 weeks followed by 2-week drug holiday until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Overall Number of Participants Analyzed 210 209
Median (95% Confidence Interval)
Unit of Measure: months
1.7
(1.5 to 2.7)
3.4
(3.0 to 4.2)
3.Secondary Outcome
Title Duration of Response
Hide Description Please refer to the protocol, overall response and best overall response will be determined solely by imaging assessment according to the RECIST Guideline Version 1.1, and will not take into account any clinical/symptomatic progression. Evaluable imaging data will be overall response without an overall response of "Not Evaluable (NE)."
Time Frame ("Earlier date on which either the overall response was assessed as PD for the first time after confirmed response or the subject died of any cause" - "Date of first assessment of confirmed CR or PR" + 1) / 30.4375.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nivolumab Arm Active Comparator Arm （Docetaxel/Paclitaxel）
Hide Arm/Group Description:
Nivolumab 240 mg/body solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Docetaxel: Intravenously administered at a dose of 75 mg/m2 every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

OR

Paclitaxel: Intravenously administered at a dose of 100 mg/m2 weekly for 6 weeks followed by 2-week drug holiday until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Overall Number of Participants Analyzed 210 209
Median (95% Confidence Interval)
Unit of Measure: months
6.9
(5.4 to 11.1)
3.9
(2.8 to 4.2)
Time Frame Monitoring for any AEs will be continued until 28 days after the end of the treatment phase. In subjects who, at the time of initiation of the follow-up investigation, have any AE for which a causal relationship to the investigational product cannot be ruled out or which led to discontinuation, investigation of the AE will be continued until the event is judged not to require further follow-up. SAEs are to be collected during the treatment period and for 100 days following the last dose.
Adverse Event Reporting Description For all-cause mortality, the number of adverse events reported as Grade 5 was extracted.
 
Arm/Group Title Nivolumab Arm Active Comparator Arm （Docetaxel/Paclitaxel）
Hide Arm/Group Description Nivolumab 240 mg/body solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Docetaxel: Intravenously administered at a dose of 75 mg/m2 every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

OR

Paclitaxel: Intravenously administered at a dose of 100 mg/m2 weekly for 6 weeks followed by 2-week drug holiday until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
All-Cause Mortality
Nivolumab Arm Active Comparator Arm （Docetaxel/Paclitaxel）
Affected / at Risk (%) Affected / at Risk (%)
Total   7/209 (3.35%)   5/208 (2.40%) 
Hide Serious Adverse Events
Nivolumab Arm Active Comparator Arm （Docetaxel/Paclitaxel）
Affected / at Risk (%) Affected / at Risk (%)
Total   68/209 (32.54%)   77/208 (37.02%) 
Blood and lymphatic system disorders     
Anemia † 1  2/209 (0.96%)  0/208 (0.00%) 
Febrile neutropenia † 1  0/209 (0.00%)  16/208 (7.69%) 
Pancytopenia † 1  0/209 (0.00%)  1/208 (0.48%) 
Bone marrow failure † 1  0/209 (0.00%)  1/208 (0.48%) 
Cardiac disorders     
Angina pectoris † 1  1/209 (0.48%)  0/208 (0.00%) 
Cardiac failure † 1  0/209 (0.00%)  1/208 (0.48%) 
Pericarditis † 1  0/209 (0.00%)  1/208 (0.48%) 
Congenital, familial and genetic disorders     
Tracheo-oesophageal fistula † 1  1/209 (0.48%)  0/208 (0.00%) 
Endocrine disorders     
Hyperthyroidism † 1  1/209 (0.48%)  0/208 (0.00%) 
Hypopituitarism † 1  1/209 (0.48%)  0/208 (0.00%) 
Inappropriate antidiuretic hormone secretion † 1  1/209 (0.48%)  0/208 (0.00%) 
Adrenocorticotropic hormone deficiency † 1  1/209 (0.48%)  0/208 (0.00%) 
Gastrointestinal disorders     
Abdominal pain † 1  1/209 (0.48%)  2/208 (0.96%) 
Colitis † 1  1/209 (0.48%)  0/208 (0.00%) 
Diarrhoea † 1  1/209 (0.48%)  2/208 (0.96%) 
Duodenitis † 1  1/209 (0.48%)  0/208 (0.00%) 
Dysphagia † 1  2/209 (0.96%)  2/208 (0.96%) 
Gastrointestinal haemorrhage † 1  1/209 (0.48%)  0/208 (0.00%) 
Ileus † 1  1/209 (0.48%)  1/208 (0.48%) 
Intestinal obstruction † 1  1/209 (0.48%)  1/208 (0.48%) 
Nausea † 1  0/209 (0.00%)  2/208 (0.96%) 
Upper gastrointestinal haemorrhage † 1  0/209 (0.00%)  1/208 (0.48%) 
Vomiting † 1  0/209 (0.00%)  2/208 (0.96%) 
Gastric fistula † 1  1/209 (0.48%)  0/208 (0.00%) 
Aorto-oesophageal fistula † 1  1/209 (0.48%)  0/208 (0.00%) 
General disorders     
Asthenia † 1  0/209 (0.00%)  1/208 (0.48%) 
Fatigue † 1  1/209 (0.48%)  1/208 (0.48%) 
Malaise † 1  1/209 (0.48%)  1/208 (0.48%) 
Pyrexia † 1  6/209 (2.87%)  1/208 (0.48%) 
Sudden death † 1  1/209 (0.48%)  1/208 (0.48%) 
Disease progression † 1  0/209 (0.00%)  1/208 (0.48%) 
Stenosis † 1  0/209 (0.00%)  1/208 (0.48%) 
Hepatobiliary disorders     
Cholecystitis † 1  1/209 (0.48%)  0/208 (0.00%) 
Hepatic function abnormal † 1  1/209 (0.48%)  0/208 (0.00%) 
Bile duct obstruction † 1  1/209 (0.48%)  0/208 (0.00%) 
Immune system disorders     
Anaphylactic shock † 1  1/209 (0.48%)  0/208 (0.00%) 
Drug hypersensitivity † 1  1/209 (0.48%)  0/208 (0.00%) 
Infections and infestations     
Appendicitis † 1  1/209 (0.48%)  0/208 (0.00%) 
Bacteraemia † 1  2/209 (0.96%)  0/208 (0.00%) 
Bronchitis † 1  1/209 (0.48%)  0/208 (0.00%) 
Infection † 1  1/209 (0.48%)  2/208 (0.96%) 
Mediastinitis † 1  1/209 (0.48%)  0/208 (0.00%) 
Pneumonia † 1  10/209 (4.78%)  13/208 (6.25%) 
Postoperative wound infection † 1  0/209 (0.00%)  1/208 (0.48%) 
Sepsis † 1  0/209 (0.00%)  2/208 (0.96%) 
Septic shock † 1  0/209 (0.00%)  1/208 (0.48%) 
Upper respiratory tract infection † 1  1/209 (0.48%)  0/208 (0.00%) 
Urinary tract infection † 1  2/209 (0.96%)  0/208 (0.00%) 
Anal abscess † 1  0/209 (0.00%)  1/208 (0.48%) 
Muscle abscess † 1  1/209 (0.48%)  0/208 (0.00%) 
Abscess neck † 1  0/209 (0.00%)  1/208 (0.48%) 
Abdominal infection † 1  1/209 (0.48%)  0/208 (0.00%) 
Intervertebral discitis † 1  1/209 (0.48%)  0/208 (0.00%) 
Pneumonia bacterial † 1  1/209 (0.48%)  1/208 (0.48%) 
Lung infection † 1  1/209 (0.48%)  5/208 (2.40%) 
Infectious pleural effusion † 1  0/209 (0.00%)  2/208 (0.96%) 
Spinal cord abscess † 1  0/209 (0.00%)  1/208 (0.48%) 
Injury, poisoning and procedural complications     
Radiation pneumonitis † 1  1/209 (0.48%)  0/208 (0.00%) 
Stoma site extravasation † 1  0/209 (0.00%)  1/208 (0.48%) 
Investigations     
Blood creatine phosphokinase increased † 1  1/209 (0.48%)  0/208 (0.00%) 
Blood creatinine increased † 1  1/209 (0.48%)  0/208 (0.00%) 
Neutrophil count decreased † 1  0/209 (0.00%)  3/208 (1.44%) 
Liver function test increased † 1  1/209 (0.48%)  0/208 (0.00%) 
Metabolism and nutrition disorders     
Cachexia † 1  1/209 (0.48%)  1/208 (0.48%) 
Dehydration † 1  2/209 (0.96%)  1/208 (0.48%) 
Hypercalcaemia † 1  4/209 (1.91%)  1/208 (0.48%) 
Hypoglycaemia † 1  2/209 (0.96%)  0/208 (0.00%) 
Hyponatraemia † 1  1/209 (0.48%)  1/208 (0.48%) 
Decreased appetite † 1  3/209 (1.44%)  6/208 (2.88%) 
Musculoskeletal and connective tissue disorders     
Fistula † 1  0/209 (0.00%)  1/208 (0.48%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Metastases to lymph nodes † 1  1/209 (0.48%)  0/208 (0.00%) 
Skin cancer † 1  0/209 (0.00%)  1/208 (0.48%) 
Tumour haemorrhage † 1  3/209 (1.44%)  1/208 (0.48%) 
Malignant neoplasm progression † 1  2/209 (0.96%)  0/208 (0.00%) 
Lymphangiosis carcinomatosa † 1  1/209 (0.48%)  0/208 (0.00%) 
Cancer pain † 1  1/209 (0.48%)  0/208 (0.00%) 
Renal and urinary disorders     
Acute kidney injury † 1  1/209 (0.48%)  0/208 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea † 1  3/209 (1.44%)  1/208 (0.48%) 
Interstitial lung disease † 1  4/209 (1.91%)  3/208 (1.44%) 
Pleural effusion † 1  1/209 (0.48%)  3/208 (1.44%) 
Pleurisy † 1  0/209 (0.00%)  1/208 (0.48%) 
Pneumonia aspiration † 1  3/209 (1.44%)  2/208 (0.96%) 
Pneumonitis † 1  3/209 (1.44%)  3/208 (1.44%) 
Pneumothorax † 1  1/209 (0.48%)  3/208 (1.44%) 
Pneumothorax spontaneous † 1  1/209 (0.48%)  0/208 (0.00%) 
Pulmonary embolism † 1  1/209 (0.48%)  0/208 (0.00%) 
Respiratory failure † 1  1/209 (0.48%)  0/208 (0.00%) 
Oesophagobronchial fistula † 1  2/209 (0.96%)  0/208 (0.00%) 
Tracheal fistula † 1  1/209 (0.48%)  0/208 (0.00%) 
Skin and subcutaneous tissue disorders     
Skin ulcer † 1  0/209 (0.00%)  1/208 (0.48%) 
Stevens-Johnson syndrome † 1  1/209 (0.48%)  0/208 (0.00%) 
Surgical and medical procedures     
Jejunostomy † 1  1/209 (0.48%)  0/208 (0.00%) 
Vascular disorders     
Hypotension † 1  0/209 (0.00%)  1/208 (0.48%) 
Venous thrombosis † 1  0/209 (0.00%)  1/208 (0.48%) 
Embolism † 1  0/209 (0.00%)  1/208 (0.48%) 
1
Term from vocabulary, MedDRA 21.1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Nivolumab Arm Active Comparator Arm （Docetaxel/Paclitaxel）
Affected / at Risk (%) Affected / at Risk (%)
Total   185/209 (88.52%)   204/208 (98.08%) 
Blood and lymphatic system disorders     
Anaemia † 1  24/209 (11.48%)  61/208 (29.33%) 
Leukopenia † 1  0/209 (0.00%)  18/208 (8.65%) 
Neutropenia † 1  1/209 (0.48%)  40/208 (19.23%) 
Endocrine disorders     
Hypothyroidism † 1  21/209 (10.05%)  3/208 (1.44%) 
Gastrointestinal disorders     
Abdominal pain † 1  12/209 (5.74%)  8/208 (3.85%) 
Constipation † 1  35/209 (16.75%)  40/208 (19.23%) 
Diarrhoea † 1  36/209 (17.22%)  34/208 (16.35%) 
Dysphagia † 1  13/209 (6.22%)  3/208 (1.44%) 
Nausea † 1  23/209 (11.00%)  40/208 (19.23%) 
Stomatitis † 1  7/209 (3.35%)  26/208 (12.50%) 
Vomiting † 1  12/209 (5.74%)  17/208 (8.17%) 
General disorders     
Chest pain † 1  13/209 (6.22%)  4/208 (1.92%) 
Fatigue † 1  19/209 (9.09%)  52/208 (25.00%) 
Malaise † 1  12/209 (5.74%)  49/208 (23.56%) 
Pyrexia † 1  29/209 (13.88%)  38/208 (18.27%) 
Infections and infestations     
Nasopharyngitis † 1  13/209 (6.22%)  9/208 (4.33%) 
Upper respiratory tract infection † 1  15/209 (7.18%)  13/208 (6.25%) 
Investigations     
Alanine aminotransferase increased † 1  11/209 (5.26%)  7/208 (3.37%) 
Aspartate aminotransferase increased † 1  13/209 (6.22%)  7/208 (3.37%) 
Lymphocyte count decreased † 1  5/209 (2.39%)  21/208 (10.10%) 
Neutrophil count decreased † 1  3/209 (1.44%)  76/208 (36.54%) 
Weight decreased † 1  11/209 (5.26%)  11/208 (5.29%) 
White blood cell count decreased † 1  2/209 (0.96%)  72/208 (34.62%) 
Metabolism and nutrition disorders     
Decreased appetite † 1  40/209 (19.14%)  68/208 (32.69%) 
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  10/209 (4.78%)  25/208 (12.02%) 
Myalgia † 1  6/209 (2.87%)  22/208 (10.58%) 
Nervous system disorders     
Dysgeusia † 1  5/209 (2.39%)  14/208 (6.73%) 
Neuropathy peripheral † 1  0/209 (0.00%)  23/208 (11.06%) 
Peripheral sensory neuropathy † 1  1/209 (0.48%)  48/208 (23.08%) 
Psychiatric disorders     
Insomnia † 1  11/209 (5.26%)  13/208 (6.25%) 
Respiratory, thoracic and mediastinal disorders     
Cough † 1  32/209 (15.31%)  25/208 (12.02%) 
Dyspnoea † 1  12/209 (5.74%)  8/208 (3.85%) 
Skin and subcutaneous tissue disorders     
Alopecia † 1  3/209 (1.44%)  100/208 (48.08%) 
Pruritus † 1  26/209 (12.44%)  15/208 (7.21%) 
Rash † 1  26/209 (12.44%)  40/208 (19.23%) 
1
Term from vocabulary, MedDRA 21.1
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Information Center
Organization: Ono Pharmaceutical Co. Ltd
Phone: ー
EMail: clinical_trial@ono.co.jp
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT02569242    
Other Study ID Numbers: ONO-4538-24/CA209-473
First Submitted: September 30, 2015
First Posted: October 6, 2015
Results First Submitted: October 20, 2021
Results First Posted: January 14, 2022
Last Update Posted: July 6, 2022