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A Randomized Phase 2 Study of Atezolizumab (an Engineered Anti-PDL1 Antibody) Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum Therapy - "POPLAR"

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ClinicalTrials.gov Identifier: NCT01903993
Recruitment Status : Completed
First Posted : July 19, 2013
Results First Posted : May 23, 2017
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-Small Cell Lung Cancer
Interventions Drug: Docetaxel
Drug: Atezolizumab
Enrollment 287
Recruitment Details  
Pre-assignment Details A total of 527 participants were screened, of whom 287 participants were randomized. 143 participants to the docetaxel arm and 144 participants to the atezolizumab arm. Overall, 10 participants (8 in the docetaxel arm and 2 in the atezolizumab arm) did not receive any study treatment.
Arm/Group Title Docetaxel Atezolizumab
Hide Arm/Group Description Participants received docetaxel 75 milligram per squared meters (mg/m^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death. Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
Period Title: Overall Study
Started 143 144
Received Treatment [1] 135 142
Completed [2] 0 0
Not Completed 143 144
Reason Not Completed
Death             118             121
Withdrawal by Subject             15             4
Lost to Follow-up             2             3
Study Terminated by Sponsor             8             14
Terminated by Sponsor After 31 Aug 2018             0             2
[1]
Two patients in the docetaxel arm crossed over to receive atezolizumab treatment.
[2]
Study terminated by Sponsor participants either discontinued or enrolled in extension study
Arm/Group Title Docetaxel Atezolizumab Total
Hide Arm/Group Description Participants received docetaxel 75 milligram per squared meters (mg/m^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death. Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator. Total of all reporting groups
Overall Number of Baseline Participants 143 144 287
Hide Baseline Analysis Population Description
Intent to treat (ITT) population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, participants were grouped according to the treatment arm to which they were assigned.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 143 participants 144 participants 287 participants
61.8  (9.4) 61.5  (9.2) 61.6  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 143 participants 144 participants 287 participants
Female
67
  46.9%
51
  35.4%
118
  41.1%
Male
76
  53.1%
93
  64.6%
169
  58.9%
1.Primary Outcome
Title Overall Survival (OS)
Hide Description Overall Survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as dead at the time of analysis was censored at the date when they were last known to be alive.
Time Frame From the time of randomization to the date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, participants were grouped according to the treatment arm to which they were assigned.
Arm/Group Title Docetaxel Atezolizumab
Hide Arm/Group Description:
Participants received docetaxel 75 milligram per squared meters (mg/m^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
Overall Number of Participants Analyzed 143 144
Median (95% Confidence Interval)
Unit of Measure: months
9.7
(8.6 to 12.0)
12.6
(9.7 to 16.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Docetaxel, Atezolizumab
Comments Hazard ratios (HR) were estimated by a Cox regression model.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.0106
Comments [Not Specified]
Method Log rank (Stratified)
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.69
Confidence Interval (2-Sided) 95%
0.52 to 0.92
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Objective Response Rate (ORR)
Hide Description ORR was defined as the percentage of participants with confirmed objective tumor response, complete response (CR) or partial response (PR), as determined by investigator using RECIST v1.1 criteria. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Time Frame Baseline until date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, participants were grouped according to the treatment arm to which they were assigned.
Arm/Group Title Docetaxel Atezolizumab
Hide Arm/Group Description:
Participants received docetaxel 75 milligram per squared meters (mg/m^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
Overall Number of Participants Analyzed 143 144
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
14.7
(9.33 to 21.57)
15.3
(9.83 to 22.21)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Docetaxel, Atezolizumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.8884
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Response Rates
Estimated Value 0.59
Confidence Interval (2-Sided) 95%
-7.67 to 8.85
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Progression-Free Survival (PFS)
Hide Description PFS was defined as the time (in months) between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using response evaluation criteria In solid tumors (RECIST) v1.1. Progressive disease (PD): at least a 20% increase in the sum of diameters of target lesions including baseline In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
Time Frame From the time of randomization to the date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, participants were grouped according to the treatment arm to which they were assigned.
Arm/Group Title Docetaxel Atezolizumab
Hide Arm/Group Description:
Participants received docetaxel 75 milligram per squared meters (mg/m^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
Overall Number of Participants Analyzed 143 144
Median (95% Confidence Interval)
Unit of Measure: months
3.4
(2.8 to 4.1)
2.7
(2.0 to 4.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Docetaxel, Atezolizumab
Comments HR were estimated by a Cox regression model. The two treatment comparison was based on a stratified log-rank test.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.5563
Comments [Not Specified]
Method Log rank (Stratified)
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.71 to 1.20
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Duration of Response (DOR)
Hide Description DOR was defined as the duration from the first tumor assessment that supports the participant's objective response (CR or PR, whichever is first recorded) to disease progression or death due to any cause, whichever occurs first.
Time Frame From the time of randomization to the date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. Here, number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.
Arm/Group Title Docetaxel Atezolizumab
Hide Arm/Group Description:
Participants received docetaxel 75 milligram per squared meters (mg/m^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
Overall Number of Participants Analyzed 21 21
Median (95% Confidence Interval)
Unit of Measure: months
7.2
(5.6 to 12.5)
18.6 [1] 
(11.6 to NA)
[1]
Upper limit of confidence interval (CI) was not achieved due to low number of participants with event.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Docetaxel, Atezolizumab
Comments HR were estimated by a unstratified Cox regression model.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.0028
Comments [Not Specified]
Method Log rank (unstratified)
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.32
Confidence Interval (2-Sided) 95%
0.15 to 0.70
Estimation Comments [Not Specified]
5.Secondary Outcome
Title ORR (Modified RECIST)
Hide Description ORR was defined as the percentage of participants with confirmed objective tumor response, CR or PR, as determined by investigator using modified RECIST criteria. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to l< 10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Time Frame From the time of randomization to the date of death due to any cause or up to data cut off date: 08 May 2015 (up to 21 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, participants were grouped according to the treatment arm to which they were assigned. The data was planned to be reported for Atezolizumab arm only
Arm/Group Title Atezolizumab
Hide Arm/Group Description:
Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
Overall Number of Participants Analyzed 144
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
16.7
(10.98 to 23.78)
6.Secondary Outcome
Title PFS (Modified RECIST)
Hide Description PFS was defined as the time (in months) between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using modified RECIST criteria. PD: at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
Time Frame From the time of randomization to the date of death due to any cause or up to data cut off date: 08 May 2015 (up to 21 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, participants were grouped according to the treatment arm to which they were assigned. The data was planned to be reported for Atezolizumab arm only
Arm/Group Title Atezolizumab
Hide Arm/Group Description:
Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
Overall Number of Participants Analyzed 144
Median (95% Confidence Interval)
Unit of Measure: months
4.2
(3.9 to 6.9)
7.Secondary Outcome
Title DOR (Modified RECIST)
Hide Description DOR was defined as the duration from the first tumor assessment that supports the participant's objective response (CR or PR, whichever is first recorded) to disease progression or death due to any cause, whichever occurs first.
Time Frame From the time of randomization to the date of death due to any cause or up to data cut off date: 08 May 2015 (up to 21 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. Here, number of participants analyzed signifies the number of participants who were evaluable for this outcome measure. The data was planned to be reported for Atezolizumab arm only.
Arm/Group Title Atezolizumab
Hide Arm/Group Description:
Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
Overall Number of Participants Analyzed 24
Median (95% Confidence Interval)
Unit of Measure: months
14.9 [1] 
(11.6 to NA)
[1]
Upper limit of CI was not achieved due to low number of participants with event.
Time Frame From the first study drug to the data cutoff date: 31 August 2018
Adverse Event Reporting Description Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
 
Arm/Group Title Docetaxel Atezolizumab
Hide Arm/Group Description Participants received docetaxel 75 milligram per squared meters (mg/m^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death. Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
All-Cause Mortality
Docetaxel Atezolizumab
Affected / at Risk (%) Affected / at Risk (%)
Total   118/143 (82.52%)      121/144 (84.03%)    
Hide Serious Adverse Events
Docetaxel Atezolizumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   46/135 (34.07%)      53/142 (37.32%)    
Blood and lymphatic system disorders     
Anaemia  1  1/135 (0.74%)  3 0/142 (0.00%)  0
Febrile neutropenia  1  7/135 (5.19%)  7 0/142 (0.00%)  0
Lymphadenopathy  1  0/135 (0.00%)  0 1/142 (0.70%)  1
Neutropenia  1  2/135 (1.48%)  3 0/142 (0.00%)  0
Cardiac disorders     
Acute myocardial infarction  1  1/135 (0.74%)  1 0/142 (0.00%)  0
Atrial fibrillation  1  1/135 (0.74%)  1 0/142 (0.00%)  0
Cardiac failure  1  0/135 (0.00%)  0 1/142 (0.70%)  2
Cardiac tamponade  1  0/135 (0.00%)  0 2/142 (1.41%)  2
Pericardial effusion  1  1/135 (0.74%)  1 0/142 (0.00%)  0
Sinus tachycardia  1  1/135 (0.74%)  1 0/142 (0.00%)  0
Myocarditis  1  0/135 (0.00%)  0 1/142 (0.70%)  1
Gastrointestinal disorders     
Abdominal pain  1  1/135 (0.74%)  1 0/142 (0.00%)  0
Colitis  1  0/135 (0.00%)  0 1/142 (0.70%)  1
Constipation  1  1/135 (0.74%)  1 0/142 (0.00%)  0
Diarrhoea  1  1/135 (0.74%)  1 1/142 (0.70%)  1
Dysphagia  1  0/135 (0.00%)  0 2/142 (1.41%)  2
Haemorrhoids thrombosed  1  0/135 (0.00%)  0 1/142 (0.70%)  1
Large intestine perforation  1  0/135 (0.00%)  0 1/142 (0.70%)  1
Nausea  1  0/135 (0.00%)  0 1/142 (0.70%)  1
Small intestinal obstruction  1  0/135 (0.00%)  0 1/142 (0.70%)  1
Upper gastrointestinal haemorrhage  1  1/135 (0.74%)  1 0/142 (0.00%)  0
General disorders     
Asthenia  1  1/135 (0.74%)  1 0/142 (0.00%)  0
Death  1  2/135 (1.48%)  2 1/142 (0.70%)  1
Fatigue  1  1/135 (0.74%)  1 0/142 (0.00%)  0
Influenza like illness  1  0/135 (0.00%)  0 1/142 (0.70%)  1
Oedema peripheral  1  0/135 (0.00%)  0 1/142 (0.70%)  1
Pain  1  0/135 (0.00%)  0 1/142 (0.70%)  1
Pyrexia  1  1/135 (0.74%)  1 3/142 (2.11%)  3
Ulcer haemorrhage  1  0/135 (0.00%)  0 1/142 (0.70%)  2
Immune system disorders     
Contrast Media Allergy  1  0/135 (0.00%)  0 1/142 (0.70%)  1
Drug Hypersensitivity  1  0/135 (0.00%)  0 1/142 (0.70%)  1
Infections and infestations     
Bronchitis  1  0/135 (0.00%)  0 1/142 (0.70%)  1
Cellulitis  1  0/135 (0.00%)  0 1/142 (0.70%)  1
H1N1 influenza  1  0/135 (0.00%)  0 1/142 (0.70%)  1
Infectious pleural effusion  1  0/135 (0.00%)  0 1/142 (0.70%)  1
Lower respiratory tract infection  1  0/135 (0.00%)  0 1/142 (0.70%)  1
Lung infection  1  0/135 (0.00%)  0 1/142 (0.70%)  1
Pharyngitis  1  0/135 (0.00%)  0 1/142 (0.70%)  1
Pneumonia  1  3/135 (2.22%)  3 10/142 (7.04%)  13
Respiratory tract infection  1  0/135 (0.00%)  0 1/142 (0.70%)  1
Respiratory tract infection bacterial  1  0/135 (0.00%)  0 1/142 (0.70%)  1
Sepsis  1  3/135 (2.22%)  5 0/142 (0.00%)  0
Osteomyelitis  1  0/135 (0.00%)  0 1/142 (0.70%)  1
Injury, poisoning and procedural complications     
Radiation pneumonitis  1  1/135 (0.74%)  1 0/142 (0.00%)  0
Investigations     
Alanine aminotransferase increased  1  0/135 (0.00%)  0 1/142 (0.70%)  1
Aspartate aminotransferase increased  1  0/135 (0.00%)  0 2/142 (1.41%)  2
Neutrophil count decreased  1  1/135 (0.74%)  1 0/142 (0.00%)  0
Urine output decreased  1  1/135 (0.74%)  1 0/142 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration  1  1/135 (0.74%)  1 0/142 (0.00%)  0
Hyperglycaemia  1  1/135 (0.74%)  1 0/142 (0.00%)  0
Type 2 diabetes mellitus  1  1/135 (0.74%)  1 0/142 (0.00%)  0
Cachexia  1  0/135 (0.00%)  0 1/142 (0.70%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/135 (0.00%)  0 1/142 (0.70%)  1
Back pain  1  1/135 (0.74%)  1 0/142 (0.00%)  0
Myalgia  1  0/135 (0.00%)  0 1/142 (0.70%)  1
Spinal osteoarthritis  1  0/135 (0.00%)  0 1/142 (0.70%)  1
Thoracic Spinal Stenosis  1  1/135 (0.74%)  1 0/142 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer pain  1  1/135 (0.74%)  1 0/142 (0.00%)  0
Tumour associated fever  1  1/135 (0.74%)  1 0/142 (0.00%)  0
Nervous system disorders     
Hypoaesthesia  1  1/135 (0.74%)  1 0/142 (0.00%)  0
Paraesthesia  1  1/135 (0.74%)  1 0/142 (0.00%)  0
Peripheral sensory neuropathy  1  0/135 (0.00%)  0 1/142 (0.70%)  1
Headache  1  0/135 (0.00%)  0 1/142 (0.70%)  1
Cerebrovascular Accident  1  0/135 (0.00%)  0 1/142 (0.70%)  1
Product Issues     
Device Dislocation  1  0/135 (0.00%)  0 1/142 (0.70%)  1
Psychiatric disorders     
Confusional state  1  0/135 (0.00%)  0 1/142 (0.70%)  1
Delirium  1  1/135 (0.74%)  1 0/142 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury  1  1/135 (0.74%)  1 1/142 (0.70%)  1
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome  1  1/135 (0.74%)  2 0/142 (0.00%)  0
Chronic obstructive pulmonary disease  1  2/135 (1.48%)  2 0/142 (0.00%)  0
Dyspnoea  1  1/135 (0.74%)  1 8/142 (5.63%)  8
Haemoptysis  1  3/135 (2.22%)  3 1/142 (0.70%)  1
Hypoxia  1  0/135 (0.00%)  0 2/142 (1.41%)  2
Pleural effusion  1  0/135 (0.00%)  0 4/142 (2.82%)  4
Pleurisy  1  0/135 (0.00%)  0 1/142 (0.70%)  1
Pneumonitis  1  0/135 (0.00%)  0 1/142 (0.70%)  2
Pneumothorax  1  0/135 (0.00%)  0 2/142 (1.41%)  3
Pulmonary embolism  1  6/135 (4.44%)  6 2/142 (1.41%)  2
Skin and subcutaneous tissue disorders     
Rash  1  0/135 (0.00%)  0 2/142 (1.41%)  2
Vascular disorders     
Embolism  1  0/135 (0.00%)  0 1/142 (0.70%)  1
Peripheral embolism  1  1/135 (0.74%)  1 0/142 (0.00%)  0
Peripheral ischaemia  1  1/135 (0.74%)  2 0/142 (0.00%)  0
Superior vena cava syndrome  1  0/135 (0.00%)  0 1/142 (0.70%)  1
Venous stenosis  1  0/135 (0.00%)  0 1/142 (0.70%)  1
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%
Docetaxel Atezolizumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   125/135 (92.59%)      127/142 (89.44%)    
Blood and lymphatic system disorders     
Anaemia  1  27/135 (20.00%)  38 28/142 (19.72%)  53
Neutropenia  1  15/135 (11.11%)  23 3/142 (2.11%)  4
Endocrine disorders     
Hypothyroidism  1  0/135 (0.00%)  0 13/142 (9.15%)  14
Eye disorders     
Lacrimation increased  1  7/135 (5.19%)  9 1/142 (0.70%)  1
Gastrointestinal disorders     
Constipation  1  32/135 (23.70%)  34 32/142 (22.54%)  33
Diarrhoea  1  38/135 (28.15%)  51 25/142 (17.61%)  38
Dyspepsia  1  7/135 (5.19%)  7 4/142 (2.82%)  4
Gastrooesophageal reflux disease  1  7/135 (5.19%)  8 8/142 (5.63%)  12
Nausea  1  45/135 (33.33%)  64 32/142 (22.54%)  45
Stomatitis  1  9/135 (6.67%)  9 3/142 (2.11%)  3
Vomiting  1  18/135 (13.33%)  20 20/142 (14.08%)  26
General disorders     
Asthenia  1  22/135 (16.30%)  28 16/142 (11.27%)  26
Chest pain  1  6/135 (4.44%)  8 12/142 (8.45%)  13
Fatigue  1  55/135 (40.74%)  87 55/142 (38.73%)  82
Oedema peripheral  1  13/135 (9.63%)  18 9/142 (6.34%)  11
Pain  1  10/135 (7.41%)  11 6/142 (4.23%)  7
Pyrexia  1  16/135 (11.85%)  19 23/142 (16.20%)  28
Influenza like illness  1  2/135 (1.48%)  2 8/142 (5.63%)  10
Chills  1  4/135 (2.96%)  4 8/142 (5.63%)  9
Infections and infestations     
Upper respiratory tract infection  1  3/135 (2.22%)  5 12/142 (8.45%)  17
Investigations     
Weight decreased  1  11/135 (8.15%)  11 20/142 (14.08%)  24
Alanine Aminotransferase Increased  1  0/135 (0.00%)  0 8/142 (5.63%)  16
Aspartate Aminotransferase Increased  1  1/135 (0.74%)  1 10/142 (7.04%)  21
Metabolism and nutrition disorders     
Decreased appetite  1  29/135 (21.48%)  37 51/142 (35.92%)  60
Dehydration  1  11/135 (8.15%)  11 6/142 (4.23%)  8
Hypokalaemia  1  4/135 (2.96%)  4 9/142 (6.34%)  12
Hyponatraemia  1  4/135 (2.96%)  4 9/142 (6.34%)  15
Hypomagnesaemia  1  6/135 (4.44%)  7 10/142 (7.04%)  15
Musculoskeletal and connective tissue disorders     
Arthralgia  1  12/135 (8.89%)  16 23/142 (16.20%)  28
Back pain  1  10/135 (7.41%)  11 21/142 (14.79%)  22
Musculoskeletal chest pain  1  4/135 (2.96%)  5 9/142 (6.34%)  13
Musculoskeletal pain  1  8/135 (5.93%)  8 20/142 (14.08%)  20
Myalgia  1  18/135 (13.33%)  24 9/142 (6.34%)  10
Pain in extremity  1  14/135 (10.37%)  19 10/142 (7.04%)  12
Nervous system disorders     
Dizziness  1  11/135 (8.15%)  12 10/142 (7.04%)  16
Headache  1  10/135 (7.41%)  10 15/142 (10.56%)  18
Neuropathy peripheral  1  17/135 (12.59%)  21 4/142 (2.82%)  7
Peripheral sensory neuropathy  1  12/135 (8.89%)  21 1/142 (0.70%)  2
Psychiatric disorders     
Insomnia  1  11/135 (8.15%)  12 24/142 (16.90%)  26
Respiratory, thoracic and mediastinal disorders     
Cough  1  33/135 (24.44%)  40 45/142 (31.69%)  61
Dyspnoea  1  27/135 (20.00%)  32 35/142 (24.65%)  41
Dyspnoea exertional  1  3/135 (2.22%)  3 11/142 (7.75%)  12
Haemoptysis  1  6/135 (4.44%)  10 15/142 (10.56%)  21
Productive cough  1  2/135 (1.48%)  2 10/142 (7.04%)  14
Skin and subcutaneous tissue disorders     
Alopecia  1  52/135 (38.52%)  57 3/142 (2.11%)  3
Dry skin  1  10/135 (7.41%)  10 5/142 (3.52%)  6
Nail disorder  1  9/135 (6.67%)  9 1/142 (0.70%)  1
Pruritus  1  6/135 (4.44%)  6 16/142 (11.27%)  26
Rash  1  16/135 (11.85%)  19 15/142 (10.56%)  30
Vascular disorders     
Hypotension  1  4/135 (2.96%)  4 9/142 (6.34%)  9
1
Term from vocabulary, MedDRA (21.1)
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 ext 8590
EMail: genentech@druginfo.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01903993    
Other Study ID Numbers: GO28753
2013-001142-34 ( EudraCT Number )
First Submitted: July 17, 2013
First Posted: July 19, 2013
Results First Submitted: November 16, 2016
Results First Posted: May 23, 2017
Last Update Posted: October 2, 2019