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A Study of Atezolizumab as First-line Monotherapy for Advanced or Metastatic Non-Small Cell Lung Cancer (B-F1RST)

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ClinicalTrials.gov Identifier: NCT02848651
Recruitment Status : Completed
First Posted : July 28, 2016
Results First Posted : April 28, 2020
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-Small Cell Lung Cancer
Intervention Drug: Atezolizumab
Enrollment 153
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Atezolizumab
Hide Arm/Group Description Participants received 1200 milligrams (mg) of atezolizumab administered by intravenous infusion every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity (up to a total of 2 years of atezolizumab treatment).
Period Title: Overall Study
Started 153
Received Treatment 152
Completed 47
Not Completed 106
Reason Not Completed
Death             85
Lost to Follow-up             1
Non-Compliance             1
Symptomatic Deterioration             1
Physician Decision             4
Withdrawal by Subject             14
Arm/Group Title Atezolizumab
Hide Arm/Group Description Participants received 1200 milligrams (mg) of atezolizumab administered by intravenous infusion every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity (up to a total of 2 years of atezolizumab treatment).
Overall Number of Baseline Participants 152
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 152 participants
68.7  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 152 participants
Female
69
  45.4%
Male
83
  54.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 152 participants
Hispanic or Latino
3
   2.0%
Not Hispanic or Latino
147
  96.7%
Unknown or Not Reported
2
   1.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 152 participants
American Indian or Alaska Native
1
   0.7%
Asian
1
   0.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
13
   8.6%
White
135
  88.8%
More than one race
0
   0.0%
Unknown or Not Reported
2
   1.3%
1.Primary Outcome
Title Percentage of Participants With Objective Response Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Determined by Investigator
Hide Description Investigator-assessed objective response rate was defined as the proportion of participants who had a confirmed best overall response of either PR or CR per RECIST v1.1.
Time Frame Baseline up to 32 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy and Safety analysis Population included participants who received at least one dose of study drug.
Arm/Group Title Atezolizumab
Hide Arm/Group Description:
Participants received 1200 milligrams (mg) of atezolizumab administered by intravenous infusion every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity (up to a total of 2 years of atezolizumab treatment).
Overall Number of Participants Analyzed 152
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
17.1
(11.62 to 23.86)
2.Primary Outcome
Title Progression-Free Survival (PFS) Per RECIST v1.1 as Determined by Investigator, by Positive Versus Negative bTMB Groups
Hide Description Investigator-assessed PFS by RECIST v1.1 was defined as the time from the first dose of study drug to the time of PD or death from any cause during the study, whichever occurred first.
Time Frame Baseline up to 32 months
Hide Outcome Measure Data
Hide Analysis Population Description
Biomarker analysis population included all participants who received at least one dose of study drug and whose tumor samples had a maximum somatic allele frequency (MSAF) >= 1%.
Arm/Group Title bTMB Low (<16) bTMB High (>=16)
Hide Arm/Group Description:
Blood tumor mutational burdern (bTMB) Low (<16)
Blood tumor mutational burden (bTMB) High (>=16)
Overall Number of Participants Analyzed 91 28
Median (95% Confidence Interval)
Unit of Measure: Months
3.55
(2.63 to 4.30)
4.98
(1.58 to 10.81)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection bTMB Low (<16), bTMB High (>=16)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3502
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.80
Confidence Interval (2-Sided) 90%
0.54 to 1.18
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Progression-Free Survival (PFS) Per RECIST v1.1 as Determined by Investigator
Hide Description Investigator-assessed PFS by RECIST v1.1 was defined as the time from the first dose of study drug to the time of PD or death from any cause during the study, whichever occurred first.
Time Frame Baseline up to 32 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Population included all participants who received at least one dose of atezolizumab.
Arm/Group Title Atezolizumab
Hide Arm/Group Description:
Participants received 1200 milligrams (mg) of atezolizumab administered by intravenous infusion every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity (up to a total of 2 years of atezolizumab treatment).
Overall Number of Participants Analyzed 152
Median (95% Confidence Interval)
Unit of Measure: Months
4.14
(2.76 to 4.90)
4.Secondary Outcome
Title Duration of Response (DOR) Per RECIST v1.1 as Determined by Investigator
Hide Description Investigator-assessed DOR by RECIST v1.1 was defined as the time from initial occurrence of documented CR or PR until documented disease progression as determined by the investigator, or death, whichever occurred first.
Time Frame Baseline up to 32 months
Hide Outcome Measure Data
Hide Analysis Population Description
Duration of response included a subset of participants who achieved an objective response in the efficacy evaluable population.
Arm/Group Title Atezolizumab
Hide Arm/Group Description:
Participants received 1200 milligrams (mg) of atezolizumab administered by intravenous infusion every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity (up to a total of 2 years of atezolizumab treatment).
Overall Number of Participants Analyzed 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Months
16.33 [1] 
(10.15 to NA)
[1]
Upper limit is not available because at the time of data cutoff, the upper limit of 95% CI is not estimable.
5.Secondary Outcome
Title Disease Control Rate (DCR) Per RECIST v1.1 as Determined by Investigator
Hide Description Confirmed disease control rate (cDCR) was defined as the rate of patients with CR or PR as the best response, or SD maintained for 24 weeks, per RECIST v1.1.
Time Frame Baseline up to 32 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Population included all participants who received at least one dose of atezolizumab.
Arm/Group Title Atezolizumab
Hide Arm/Group Description:
Participants received 1200 milligrams (mg) of atezolizumab administered by intravenous infusion every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity (up to a total of 2 years of atezolizumab treatment).
Overall Number of Participants Analyzed 152
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage
32.9
(25.50 to 40.74)
6.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the time from the first dose of study drug to the time of death from any cause during the study.
Time Frame From baseline until death (up to 32 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Population included all participants who received at least one dose of atezolizumab.
Arm/Group Title Atezolizumab
Hide Arm/Group Description:
Participants received 1200 milligrams (mg) of atezolizumab administered by intravenous infusion every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity (up to a total of 2 years of atezolizumab treatment).
Overall Number of Participants Analyzed 152
Median (95% Confidence Interval)
Unit of Measure: Months
14.82
(12.68 to 21.29)
7.Secondary Outcome
Title Percentage of Participants With Adverse Events
Hide Description Adverse events were defined as any untoward medical occurrence in a subject administered atezolizumab, regardless of causal attribution.
Time Frame Baseline up to 32 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analyses population included all participants who received at least one dose of study drug.
Arm/Group Title Atezolizumab
Hide Arm/Group Description:
Participants received 1200 milligrams (mg) of atezolizumab administered by intravenous infusion every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity (up to a total of 2 years of atezolizumab treatment).
Overall Number of Participants Analyzed 152
Measure Type: Number
Unit of Measure: Percentage of Participants
100
8.Secondary Outcome
Title Percentage of Participants Who Are Alive and Progression-Free (Per RECIST v1.1) at 6, 9, 12, and 18 Months by Various bTMB Quantiles
Hide Description A summary of the number of patients at risk and survival rate for the time points of 6, 9, 12, and 18 months.
Time Frame Months 6, 9, 12, and 18
Hide Outcome Measure Data
Hide Analysis Population Description
Biomarker analysis population included all participants who received at least one dose of study drug and whose tumor samples had a maximum somatic allele frequency (MSAF) >=1%.
Arm/Group Title bTMB <10 bTMB >=10 bTMB <16 bTMB >=16 bTMB <20 bTMB >=20
Hide Arm/Group Description:
Blood tumor mutational burden (bTMB) <10.
Blood tumor mutational burden (bTMb) >=10.
Blood tumor mutational burden (bTMB) <16.
Blood tumor mutational burden (bTMB) >=16.
Blood tumor mutational burden (bTMB) <20.
Blood tumor mutational burden (bTMB) >=20.
Overall Number of Participants Analyzed 70 49 91 28 100 19
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
6 Months Number Analyzed 20 participants 17 participants 25 participants 12 participants 27 participants 10 participants
35.67
(23.91 to 47.43)
34.69
(21.37 to 48.02)
32.85
(22.85 to 42.86)
42.86
(24.53 to 61.19)
31.91
(22.47 to 41.34)
52.63
(30.18 to 75.08)
9 Months Number Analyzed 12 participants 11 participants 12 participants 11 participants 14 participants 9 participants
23.19
(12.51 to 33.86)
22.45
(10.77 to 34.13)
16.90
(8.60 to 25.19)
39.29
(21.20 to 57.38)
17.58
(9.61 to 25.55)
47.37
(24.92 to 69.82)
12 Months Number Analyzed 8 participants 7 participants 8 participants 7 participants 9 participants 6 participants
16.86
(6.99 to 26.74)
14.29
(4.49 to 24.08)
12.29
(4.79 to 19.78)
25.00
(8.96 to 41.04)
12.24
(5.17 to 19.31)
31.58
(10.68 to 52.48)
18 Months Number Analyzed 3 participants 4 participants 3 participants 4 participants 3 participants 4 participants
14.45
(4.93 to 23.98)
8.16
(0.50 to 15.83)
10.53
(3.36 to 17.70)
14.29
(1.32 to 27.25)
9.33
(2.88 to 15.78)
21.05
(2.72 to 39.38)
9.Secondary Outcome
Title OS by Various bTMB Cutoff Points 16 and 20
Hide Description OS was defined as the time from the first dose of study drug to the time of death from any cause during the study.
Time Frame From baseline until death (up to 32 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Biomarker analysis population included all participants who received at least one dose of study drug and whose tumor samples had a maximum somatic allele frequency (MSAF) >= 1%.
Arm/Group Title bTMB <16 bTMB >=16 bTMB <20 bTMB >=20
Hide Arm/Group Description:
Blood tumor mutational burden (bTMB) <16.
Blood tumor mutational burden (bTMB) >=16.
Blood tumor mutational burden (bTMB) <20
Blood tumor mutational burden (bTMB) >=20.
Overall Number of Participants Analyzed 91 28 100 19
Median (95% Confidence Interval)
Unit of Measure: Months
13.37
(11.70 to 18.00)
23.85 [1] 
(8.77 to NA)
13.14
(10.48 to 17.71)
23.85 [1] 
(15.70 to NA)
[1]
Upper limit is not available because at the time of data cutoff, the upper limit of 95% CI is not estimable.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection bTMB <16, bTMB >=16
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1783
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.66
Confidence Interval (2-Sided) 90%
0.40 to 1.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection bTMB <20, bTMB >=20
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0358
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.44
Confidence Interval (2-Sided) 90%
0.23 to 0.85
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Participants With Objective Response (Per RECIST v1.1) by Various bTMB Quantiles
Hide Description Objective response rate was defined as the proportion of participants who had a confirmed best overall response of either PR or CR per RECIST v1.1.
Time Frame Baseline up to 32 months
Hide Outcome Measure Data
Hide Analysis Population Description
Biomarker analysis population included all participants who received at least one dose of study drug and whose tumor samples had a maximum somatic allele frequency (MSAF) >=1%.
Arm/Group Title bTMB <10 bTMB >=10 bTMB <16 bTMB >=16 bTMF <20 bTMF >=20
Hide Arm/Group Description:
Blood tumor mutational burden (bTMB) <10.
Blood tumor mutational burden (bTMB) >=10.
Blood tumor mutational burdern (bTMB) <16.
Blood tumor mutational burden (bTMB) >=16.
Blood tumor mutational burden (bTMB) <20.
Blood tumor mutational burden (bTMB) >=20.
Overall Number of Participants Analyzed 70 49 91 28 100 19
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
7.1
(2.86 to 15.32)
20.4
(10.51 to 33.73)
5.5
(2.19 to 12.25)
35.7
(19.25 to 55.54)
6.0
(2.64 to 12.19)
47.4
(25.17 to 69.15)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection bTMB <10, bTMB >=10
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0326
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Differences in Rates
Estimated Value 13.27
Confidence Interval (2-Sided) 90%
2.53 to 24.00
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection bTMB <16, bTMB >=16
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Rates
Estimated Value 30.22
Confidence Interval (2-Sided) 90%
14.82 to 45.62
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection bTMF <20, bTMF >=20
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Differences in Rates
Estimated Value 41.37
Confidence Interval (2-Sided) 90%
22.13 to 60.61
Estimation Comments [Not Specified]
Time Frame Baseline up to approximately 3 years (data cut off 26 July 2019).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Atezolizumab
Hide Arm/Group Description Participants received 1200 milligrams (mg) of atezolizumab administered by intravenous infusion every 21 days until disease progression, loss of clinical benefit, or unacceptable toxicity (up to a total of 2 years of atezolizumab treatment).
All-Cause Mortality
Atezolizumab
Affected / at Risk (%)
Total   85/152 (55.92%) 
Hide Serious Adverse Events
Atezolizumab
Affected / at Risk (%)
Total   81/152 (53.29%) 
Blood and lymphatic system disorders   
Anaemia  1  1/152 (0.66%) 
Cardiac disorders   
Aortic valve stenosis  1  1/152 (0.66%) 
Atrial fibrillation  1  6/152 (3.95%) 
Atrioventricular block  1  1/152 (0.66%) 
Cardiac arrest  1  1/152 (0.66%) 
Cardiac failure  1  1/152 (0.66%) 
Cardiac tamponade  1  2/152 (1.32%) 
Palpitations  1  1/152 (0.66%) 
Pericardial effusion  1  4/152 (2.63%) 
Supraventricular tachycardia  1  3/152 (1.97%) 
Endocrine disorders   
Adrenal insufficiency  1  1/152 (0.66%) 
Gastrointestinal disorders   
Abdominal pain  1  1/152 (0.66%) 
Colitis  1  3/152 (1.97%) 
Diarrhoea  1  1/152 (0.66%) 
Gastritis  1  1/152 (0.66%) 
Gastrointestinal haemorrhage  1  2/152 (1.32%) 
Immune-mediated enterocolitis  1  1/152 (0.66%) 
Peptic ulcer haemorrhage  1  1/152 (0.66%) 
Upper gastrointestinal haemorrhage  1  1/152 (0.66%) 
Vomiting  1  1/152 (0.66%) 
General disorders   
Asthenia  1  2/152 (1.32%) 
Death  1  1/152 (0.66%) 
Non-cardiac chest pain  1  3/152 (1.97%) 
Pyrexia  1  2/152 (1.32%) 
Hepatobiliary disorders   
Bile duct obstruction  1  1/152 (0.66%) 
Infections and infestations   
Cellulitis  1  1/152 (0.66%) 
Clostridium difficile colitis  1  1/152 (0.66%) 
Infection  1  1/152 (0.66%) 
Influenza  1  2/152 (1.32%) 
Pneumonia  1  6/152 (3.95%) 
Sepsis  1  4/152 (2.63%) 
Septic Shock  1  1/152 (0.66%) 
Upper respiratory tract infection  1  1/152 (0.66%) 
Urinary tract infection  1  3/152 (1.97%) 
Injury, poisoning and procedural complications   
Cervical vertebral fracture  1  1/152 (0.66%) 
Compression fracture  1  1/152 (0.66%) 
Fall  1  3/152 (1.97%) 
Infusion related reaction  1  1/152 (0.66%) 
Seroma  1  1/152 (0.66%) 
Metabolism and nutrition disorders   
Dehydration  1  2/152 (1.32%) 
Failure to thrive  1  1/152 (0.66%) 
Hyperglycaemia  1  2/152 (1.32%) 
Hypokalaemia  1  1/152 (0.66%) 
Hyponatraemia  1  2/152 (1.32%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  2/152 (1.32%) 
Muscular weakness  1  1/152 (0.66%) 
Musculoskeletal chest pain  1  1/152 (0.66%) 
Neck pain  1  1/152 (0.66%) 
Pain in extremity  1  1/152 (0.66%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Malignant pleural effusion  1  1/152 (0.66%) 
Metastases to central nervous system  1  1/152 (0.66%) 
Transitional cell carcinoma  1  1/152 (0.66%) 
Nervous system disorders   
Cerebrovascular accident  1  2/152 (1.32%) 
Embolic stroke  1  2/152 (1.32%) 
Syncope  1  1/152 (0.66%) 
Psychiatric disorders   
Confusional state  1  1/152 (0.66%) 
Mental status changes  1  1/152 (0.66%) 
Renal and urinary disorders   
Acute kidney injury  1  3/152 (1.97%) 
Nephritis  1  1/152 (0.66%) 
Respiratory, thoracic and mediastinal disorders   
Acute respiratory failure  1  5/152 (3.29%) 
Chronic obstructive pulmonary disease  1  1/152 (0.66%) 
Dyspnoea  1  14/152 (9.21%) 
Haemoptysis  1  1/152 (0.66%) 
Hypoxia  1  1/152 (0.66%) 
Pleural effusion  1  1/152 (0.66%) 
Pneumonia aspiration  1  1/152 (0.66%) 
Pneumonitis  1  7/152 (4.61%) 
Pneumothorax  1  1/152 (0.66%) 
Pulmonary artery occlusion  1  1/152 (0.66%) 
Pulmonary embolism  1  5/152 (3.29%) 
Pulmonary haemorrhage  1  3/152 (1.97%) 
Respiratory failure  1  3/152 (1.97%) 
Vascular disorders   
Embolism  1  1/152 (0.66%) 
Hypotension  1  1/152 (0.66%) 
Peripheral embolism  1  1/152 (0.66%) 
Peripheral ischaemia  1  1/152 (0.66%) 
1
Term from vocabulary, MedDRA version 22.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Atezolizumab
Affected / at Risk (%)
Total   146/152 (96.05%) 
Blood and lymphatic system disorders   
Anaemia  1  24/152 (15.79%) 
Endocrine disorders   
Hypothyroidism  1  13/152 (8.55%) 
Gastrointestinal disorders   
Nausea  1  42/152 (27.63%) 
Diarrhoea  1  36/152 (23.68%) 
Constipation  1  29/152 (19.08%) 
Vomiting  1  17/152 (11.18%) 
Abdominal pain  1  8/152 (5.26%) 
General disorders   
Fatigue  1  67/152 (44.08%) 
Oedema Peripheral  1  21/152 (13.82%) 
Pyrexia  1  12/152 (7.89%) 
Non-cardiac chest pain  1  11/152 (7.24%) 
Chills  1  9/152 (5.92%) 
Pain  1  8/152 (5.26%) 
Infections and infestations   
Urinary tract infection  1  13/152 (8.55%) 
Upper respiratory tract infection  1  11/152 (7.24%) 
Pneumonia  1  9/152 (5.92%) 
Injury, poisoning and procedural complications   
Infusion related reaction  1  8/152 (5.26%) 
Investigations   
Weight decreased  1  25/152 (16.45%) 
Blood alkaline phosphatase increased  1  14/152 (9.21%) 
Aspartate aminotransferase increased  1  13/152 (8.55%) 
Alanine aminotransferase increased  1  11/152 (7.24%) 
Blood creatinine increased  1  9/152 (5.92%) 
Metabolism and nutrition disorders   
Decreased appetite  1  41/152 (26.97%) 
Hypokalaemia  1  26/152 (17.11%) 
Hyponatraemia  1  22/152 (14.47%) 
Hyperglycaemia  1  21/152 (13.82%) 
Dehydration  1  18/152 (11.84%) 
Hypoalbuminaemia  1  18/152 (11.84%) 
Hypomagnesaemia  1  17/152 (11.18%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  31/152 (20.39%) 
Back pain  1  23/152 (15.13%) 
Myalgia  1  15/152 (9.87%) 
Musculoskeletal chest pain  1  13/152 (8.55%) 
Musculoskeletal pain  1  13/152 (8.55%) 
Neck pain  1  8/152 (5.26%) 
Nervous system disorders   
Dizziness  1  18/152 (11.84%) 
Headache  1  15/152 (9.87%) 
Dysgeusia  1  12/152 (7.89%) 
Psychiatric disorders   
Insomnia  1  23/152 (15.13%) 
Depression  1  13/152 (8.55%) 
Anxiety  1  11/152 (7.24%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  37/152 (24.34%) 
Cough  1  33/152 (21.71%) 
Productive cough  1  11/152 (7.24%) 
Skin and subcutaneous tissue disorders   
Pruritus  1  15/152 (9.87%) 
Rash maculo-papular  1  15/152 (9.87%) 
Dry skin  1  14/152 (9.21%) 
Vascular disorders   
Hypotension  1  11/152 (7.24%) 
Hypertension  1  10/152 (6.58%) 
1
Term from vocabulary, MedDRA version 22.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02848651    
Other Study ID Numbers: ML39237
First Submitted: July 26, 2016
First Posted: July 28, 2016
Results First Submitted: April 15, 2020
Results First Posted: April 28, 2020
Last Update Posted: April 28, 2020