Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 2 for:    imvigor | Urothelial Carcinoma | Italy

A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (UC) After Surgical Resection (IMvigor010)

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: NCT02450331
Recruitment Status : Active, not recruiting
First Posted : May 21, 2015
Results First Posted : November 18, 2020
Last Update Posted : January 11, 2021
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 Carcinoma, Transitional Cell
Intervention Drug: Atezolizumab
Enrollment 809
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Observation Atezolizumab
Hide Arm/Group Description Participants underwent observation starting on Day 1 for 16 cycles (up to 1 year). Participants received intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year).
Period Title: Overall Study
Started 403 406
Completed 0 0
Not Completed 403 406
Reason Not Completed
Death             120             114
Lost to Follow-up             9             7
Withdrawal by Subject             50             39
On-Study Status: In Disease recurrence follow-up             179             208
On-Study Status: In Survival follow-up             45             38
Arm/Group Title Observation Atezolizumab Total
Hide Arm/Group Description Participants underwent observation starting on Day 1 for 16 cycles (up to 1 year). Participants received intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year). Total of all reporting groups
Overall Number of Baseline Participants 403 406 809
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 403 participants 406 participants 809 participants
65.9  (9.3) 66.0  (9.0) 65.9  (9.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 403 participants 406 participants 809 participants
Female
87
  21.6%
84
  20.7%
171
  21.1%
Male
316
  78.4%
322
  79.3%
638
  78.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 403 participants 406 participants 809 participants
Hispanic or Latino
9
   2.2%
16
   3.9%
25
   3.1%
Not Hispanic or Latino
357
  88.6%
369
  90.9%
726
  89.7%
Unknown or Not Reported
37
   9.2%
21
   5.2%
58
   7.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Number of Participants
Number Analyzed 403 participants 406 participants 809 participants
American Indian or Alaska Native 0 1 1
Asian 68 64 132
Black or African American 3 3 6
White 307 320 627
Other 4 6 10
Unknown 21 12 33
1.Primary Outcome
Title Disease-Free Survival (DFS), as Assessed by Investigator
Hide Description DFS is defined as the time from randomization to the time of first occurrence of a DFS event. DFS events include: local (pelvic) recurrence of UC (including soft tissue and regional lymph nodes); urinary tract recurrence of UC (including all pathological stages and grades); distant metastasis of UC; or death from any cause. Tumor assessment will be performed using radiographic evaluations.
Time Frame Randomization up to first occurrence of DFS event (up to approximately 50 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population is defined as all randomized patients, whether or not the patient received the assigned treatment (atezolizumab/observation).
Arm/Group Title Observation Atezolizumab
Hide Arm/Group Description:
Participants underwent observation starting on Day 1 for 16 cycles (up to 1 year).
Participants received intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year).
Overall Number of Participants Analyzed 403 406
Median (95% Confidence Interval)
Unit of Measure: Months
16.6
(11.2 to 24.8)
19.4
(15.9 to 24.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Observation, Atezolizumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2446
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.892
Confidence Interval (2-Sided) 95%
0.735 to 1.081
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall survival is defined as the time from randomization to the date of death from any cause, regardless of whether the death occurs during study treatment or following treatment discontinuation.
Time Frame Randomization until death due to any cause (up to approximately 50 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population is defined as all randomized patients, whether or not the patient received the assigned treatment (atezolizumab/observation).
Arm/Group Title Observation Atezolizumab
Hide Arm/Group Description:
Participants underwent observation starting on Day 1 for 16 cycles (up to 1 year).
Participants received intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year).
Overall Number of Participants Analyzed 403 406
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(38.2 to NA)
NA [1] 
(NA to NA)
[1]
Median has not been reached.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Observation, Atezolizumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1951
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.846
Confidence Interval (2-Sided) 95%
0.657 to 1.090
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Disease-Specific Survival (DSS), as Assessed by Investigator
Hide Description DSS is defined as the time from randomization until the date of death from UC.
Time Frame Randomization until death due to UC (up to approximately 50 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population is defined as all randomized patients, whether or not the patient received the assigned treatment (atezolizumab/observation).
Arm/Group Title Observation Atezolizumab
Hide Arm/Group Description:
Participants underwent observation starting on Day 1 for 16 cycles (up to 1 year).
Participants received intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year).
Overall Number of Participants Analyzed 403 406
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Median has not been reached.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Observation, Atezolizumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.2235
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.836
Confidence Interval (2-Sided) 95%
0.626 to 1.116
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Distant Metastasis-Free Survival (DMFS)
Hide Description DMFS is defined as the time from randomization to the date of diagnosis of distant (that is, non-locoregional) metastases or death from any cause. Tumor assessment will be performed using radiographic evaluations.
Time Frame Randomization up to diagnosis of distant metastases or death from any cause (up to approximately 50 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population is defined as all randomized patients, whether or not the patient received the assigned treatment (atezolizumab/observation).
Arm/Group Title Observation Atezolizumab
Hide Arm/Group Description:
Participants underwent observation starting on Day 1 for 16 cycles (up to 1 year).
Participants received intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year).
Overall Number of Participants Analyzed 403 406
Median (95% Confidence Interval)
Unit of Measure: Months
31.1
(21.7 to 41.4)
27.5 [1] 
(22.6 to NA)
[1]
Upper bound is not estimable due to insufficient number of subjects with DMFS events.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Observation, Atezolizumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.4291
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.918
Confidence Interval (2-Sided) 95%
0.743 to 1.134
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Non-Urinary Tract Recurrence-Free Survival (NURFS)
Hide Description NURFS is defined as the time from randomization to the time of first occurrence of a NURFS event. NURFS events include: local (pelvic) recurrence of UC (including soft tissue and regional lymph nodes); distant metastasis of UC; or death from any cause. Tumor assessment will be performed using radiographic evaluations.
Time Frame Randomization up to time of first occurrence of a NURFS event (up to approximately 50 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population is defined as all randomized patients, whether or not the patient received the assigned treatment (atezolizumab/observation).
Arm/Group Title Observation Atezolizumab
Hide Arm/Group Description:
Participants underwent observation starting on Day 1 for 16 cycles (up to 1 year).
Participants received intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year).
Overall Number of Participants Analyzed 403 406
Median (95% Confidence Interval)
Unit of Measure: Months
19.5
(12.3 to 27.7)
22.1
(17.2 to 27.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Observation, Atezolizumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.1994
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.879
Confidence Interval (2-Sided) 95%
0.722 to 1.070
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With Adverse Events (AEs)
Hide Description Percentage of participants with at least one Adverse Event.
Time Frame Screening up to approximately 50 months
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population is defined as patients who received at least one dose of atezolizumab, and all patients who did not receive any dose of atezolizumab who had at least one post-baseline safety assessment (e.g.,adverse event, lab, vital signs, ECG, etc.), regardless of their assigned treatment (atezolizumab/observation).
Arm/Group Title Observation Atezolizumab
Hide Arm/Group Description:
Participants underwent observation starting on Day 1 for 16 cycles (up to 1 year).
Participants received intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year).
Overall Number of Participants Analyzed 397 390
Measure Type: Number
Unit of Measure: Percentage of Participants
78.8 94.4
7.Secondary Outcome
Title Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
Hide Description Percentage of participants with anti-therapeutic antibodies to atezolizumab.
Time Frame Baseline up to approximately 50 months
Hide Outcome Measure Data
Hide Analysis Population Description
The anti-drug antibodies (ADA)-evaluable population is defined as all patients treated with atezolizumab who have at least one post-baseline ADA result.
Arm/Group Title Atezolizumab
Hide Arm/Group Description:
Participants received intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year).
Overall Number of Participants Analyzed 375
Measure Type: Number
Unit of Measure: Percentage of Participants
29.3
8.Secondary Outcome
Title EuroQol 5-Dimension 5-Level (EQ-5D-5L) Visual Analogue Scale Score
Hide Description The EQ-5D-5L is a generic preference-based HRQoL questionnaire that provides a single index value for health status and is used to inform pharmacoeconomic evaluations and to measure general health status. Visual analog scale (VAS) allows the patient to indicate, on a scale of 0-100, how his or her health is on the day of assessment, with 100 being the "best imaginable health state" and 0 being the "worst imaginable health state."
Time Frame Day 1 of Cycle 1 up to approximately 50 months (Cycle length = 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population is defined as all randomized patients, whether or not the patient received the assigned treatment (atezolizumab/observation).
Arm/Group Title Observation Atezolizumab
Hide Arm/Group Description:
Participants underwent observation starting on Day 1 for 16 cycles (up to 1 year).
Participants received intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year).
Overall Number of Participants Analyzed 403 406
Mean (Standard Deviation)
Unit of Measure: Score on scale
Cycle 1 Day 1 Number Analyzed 375 participants 375 participants
77.41  (15.74) 78.89  (16.13)
Cycle 3 Day 1 Number Analyzed 349 participants 338 participants
78.64  (15.73) 81.05  (14.96)
Cycle 5 Day 1 Number Analyzed 277 participants 295 participants
79.94  (16.32) 81.95  (14.32)
Cycle 7 Day 1 Number Analyzed 259 participants 267 participants
80.81  (16.37) 82.39  (14.43)
Cycle 9 Day 1 Number Analyzed 228 participants 250 participants
81.24  (15.70) 82.06  (15.34)
Cycle 11 Day 1 Number Analyzed 209 participants 220 participants
81.39  (17.02) 82.81  (14.96)
Cycle 13 Day 1 Number Analyzed 190 participants 216 participants
81.39  (16.99) 82.59  (14.81)
Cycle 15 Day 1 Number Analyzed 187 participants 180 participants
82.78  (16.01) 83.67  (14.47)
Treatment Discontinuation Number Analyzed 176 participants 219 participants
82.68  (16.19) 81.91  (15.96)
9.Secondary Outcome
Title Minimum Observed Serum Atezolizumab Concentration (Cmin)
Hide Description Minimum observed serum atezolizumab concentration (Cmin) prior to infusion on Day 1 of Cycles 1, 2, 3, and 4; every 8 cycles starting on Cycle 8; at treatment discontinuation; and at 120 days after the last dose of atezolizumab.
Time Frame Pre-dose (Hour 0) on Day 1 of Cycles 1, 2, 3, 4, every 8 cycles from Cycle 8, at treatment discontinuation, 120 days after treatment discontinuation (up to approximately 50 months))(Cycle length = 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic-evaluable population is defined as all patients who received any dose of atezolizumab and who have evaluable pharmacokinetic (PK) samples.
Arm/Group Title Atezolizumab
Hide Arm/Group Description:
Participants received intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year).
Overall Number of Participants Analyzed 380
Mean (Standard Deviation)
Unit of Measure: µg/mL
Cycle 2 Day 1 Number Analyzed 355 participants
78.4  (25.2)
Cycle 3 Day 1 Number Analyzed 335 participants
125  (46.0)
Cycle 4 Day 1 Number Analyzed 323 participants
152  (71.1)
Cycle 8 Day 1 Number Analyzed 254 participants
203  (92.0)
Cycle 16 Day 1 Number Analyzed 163 participants
225  (106)
Day 120 Post Last Dose MPDL3280A Number Analyzed 195 participants
15.9  (19.5)
Study Drug or Study Phase Comp or Early Disc Number Analyzed 277 participants
164  (106)
10.Secondary Outcome
Title Maximum Observed Serum Atezolizumab Concentration (Cmax)
Hide Description Maximum observed serum atezolizumab concentration (Cmax) after infusion on Day 1 of Cycle 1.
Time Frame Day 1 of Cycle 1 (Cycle length = 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic-evaluable population is defined as all patients who received any dose of atezolizumab and who have evaluable pharmacokinetic (PK) samples.
Arm/Group Title Atezolizumab
Hide Arm/Group Description:
Participants received intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year).
Overall Number of Participants Analyzed 300
Mean (Standard Deviation)
Unit of Measure: µg/mL
365  (121)
Time Frame From the first study drug to the data cutoff date: 30 Nov 2019 (up to 50 months)
Adverse Event Reporting Description The safety-evaluable population for atezolizumab was defined as patients who received at least one dose of atezolizumab. The safety-evaluable population for observation was defined as patients randomized to observation who had at least one post-baseline safety assessment.
 
Arm/Group Title OBSERVATION ATEZOLIZUMAB
Hide Arm/Group Description Participants underwent observation starting on Day 1 for 16 cycles (up to 1 year). Participants received intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year).
All-Cause Mortality
OBSERVATION ATEZOLIZUMAB
Affected / at Risk (%) Affected / at Risk (%)
Total   124/397 (31.23%)      114/390 (29.23%)    
Hide Serious Adverse Events
OBSERVATION ATEZOLIZUMAB
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   71/397 (17.88%)      122/390 (31.28%)    
Blood and lymphatic system disorders     
Anaemia  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Cardiac disorders     
Atrial fibrillation  1  0/397 (0.00%)  0 2/390 (0.51%)  2
Bradycardia  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Cardio-respiratory arrest  1  1/397 (0.25%)  1 0/390 (0.00%)  0
Myocardial infarction  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Supraventricular tachycardia  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Endocrine disorders     
Adrenal insufficiency  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Hypophysitis  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Hypothyroidism  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Gastrointestinal disorders     
Abdominal pain  1  2/397 (0.50%)  2 0/390 (0.00%)  0
Abdominal pain upper  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Colitis  1  0/397 (0.00%)  0 4/390 (1.03%)  4
Constipation  1  2/397 (0.50%)  2 0/390 (0.00%)  0
Diarrhoea  1  0/397 (0.00%)  0 5/390 (1.28%)  5
Enterovesical fistula  1  1/397 (0.25%)  1 1/390 (0.26%)  1
Gastrointestinal haemorrhage  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Hernial eventration  1  1/397 (0.25%)  1 1/390 (0.26%)  1
Ileus  1  1/397 (0.25%)  1 1/390 (0.26%)  1
Immune-mediated enterocolitis  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Intestinal obstruction  1  2/397 (0.50%)  2 4/390 (1.03%)  5
Intestinal perforation  1  0/397 (0.00%)  0 2/390 (0.51%)  2
Mechanical ileus  1  1/397 (0.25%)  1 1/390 (0.26%)  1
Pancreatitis acute  1  1/397 (0.25%)  1 1/390 (0.26%)  1
Proctalgia  1  1/397 (0.25%)  1 0/390 (0.00%)  0
Proctitis  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Small intestinal obstruction  1  2/397 (0.50%)  2 1/390 (0.26%)  1
Small intestine ulcer  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Vomiting  1  1/397 (0.25%)  1 1/390 (0.26%)  1
General disorders     
Asthenia  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Death  1  1/397 (0.25%)  1 3/390 (0.77%)  3
Hernia pain  1  1/397 (0.25%)  1 0/390 (0.00%)  0
Hyperthermia  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Influenza like illness  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Lithiasis  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Malaise  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Pyrexia  1  4/397 (1.01%)  4 11/390 (2.82%)  11
Hepatobiliary disorders     
Autoimmune hepatitis  1  0/397 (0.00%)  0 2/390 (0.51%)  3
Bile duct stone  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Cholangitis  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Cholecystitis  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Hepatic haematoma  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Hepatitis  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Liver disorder  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Immune system disorders     
Drug hypersensitivity  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Hypersensitivity  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Systemic immune activation  1  0/397 (0.00%)  0 2/390 (0.51%)  2
Infections and infestations     
Abdominal abscess  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Bacteraemia  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Bacterial sepsis  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Cystitis  1  1/397 (0.25%)  1 0/390 (0.00%)  0
Diabetic foot infection  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Escherichia sepsis  1  1/397 (0.25%)  1 0/390 (0.00%)  0
Febrile infection  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Infection  1  1/397 (0.25%)  1 1/390 (0.26%)  1
Kidney infection  1  1/397 (0.25%)  1 1/390 (0.26%)  1
Lower respiratory tract infection  1  1/397 (0.25%)  1 1/390 (0.26%)  1
Neuroborreliosis  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Osteomyelitis  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Pneumonia  1  2/397 (0.50%)  2 4/390 (1.03%)  4
Pyelonephritis  1  9/397 (2.27%)  11 12/390 (3.08%)  16
Pyelonephritis acute  1  1/397 (0.25%)  1 1/390 (0.26%)  2
Pyelonephritis chronic  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Renal abscess  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Respiratory tract infection  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Sepsis  1  1/397 (0.25%)  1 3/390 (0.77%)  5
Septic shock  1  1/397 (0.25%)  1 0/390 (0.00%)  0
Sinusitis  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Upper respiratory tract infection  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Urinary tract infection  1  19/397 (4.79%)  22 30/390 (7.69%)  41
Urinary tract infection bacterial  1  1/397 (0.25%)  1 1/390 (0.26%)  1
Urosepsis  1  3/397 (0.76%)  3 1/390 (0.26%)  1
Vascular device infection  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Wound infection  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Injury, poisoning and procedural complications     
Incision site impaired healing  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Infusion related reaction  1  0/397 (0.00%)  0 2/390 (0.51%)  2
Post procedural haemorrhage  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Stoma obstruction  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Stomal hernia  1  1/397 (0.25%)  1 0/390 (0.00%)  0
Ureteric anastomosis complication  1  1/397 (0.25%)  1 0/390 (0.00%)  0
Urostomy complication  1  1/397 (0.25%)  1 0/390 (0.00%)  0
Metabolism and nutrition disorders     
Acidosis  1  1/397 (0.25%)  1 1/390 (0.26%)  1
Dehydration  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Diabetes mellitus  1  1/397 (0.25%)  1 1/390 (0.26%)  1
Hypercalcaemia  1  1/397 (0.25%)  1 0/390 (0.00%)  0
Hyperglycaemia  1  2/397 (0.50%)  2 1/390 (0.26%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Arthritis  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Groin pain  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Musculoskeletal pain  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Pain in extremity  1  0/397 (0.00%)  0 2/390 (0.51%)  2
Rotator cuff syndrome  1  1/397 (0.25%)  1 0/390 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma gastric  1  1/397 (0.25%)  1 0/390 (0.00%)  0
Gastric cancer  1  1/397 (0.25%)  1 0/390 (0.00%)  0
Laryngeal squamous cell carcinoma  1  1/397 (0.25%)  1 0/390 (0.00%)  0
Lung adenocarcinoma  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Squamous cell carcinoma of lung  1  1/397 (0.25%)  1 0/390 (0.00%)  0
Tumour of ampulla of Vater  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Nervous system disorders     
Cerebral haemorrhage  1  1/397 (0.25%)  1 0/390 (0.00%)  0
Cerebrovascular accident  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Headache  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Immune-mediated neuropathy  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Ischaemic stroke  1  1/397 (0.25%)  1 0/390 (0.00%)  0
Neuropathy peripheral  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Syncope  1  1/397 (0.25%)  1 0/390 (0.00%)  0
Product Issues     
Device dislocation  1  1/397 (0.25%)  1 0/390 (0.00%)  0
Device occlusion  1  1/397 (0.25%)  1 0/390 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury  1  4/397 (1.01%)  4 8/390 (2.05%)  8
Autoimmune nephritis  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Dysuria  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Hydronephrosis  1  1/397 (0.25%)  1 1/390 (0.26%)  1
Nephritis  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Nephrolithiasis  1  0/397 (0.00%)  0 1/390 (0.26%)  3
Renal impairment  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Renal injury  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Ureteric obstruction  1  1/397 (0.25%)  2 1/390 (0.26%)  1
Ureteric stenosis  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Ureterolithiasis  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Urinary retention  1  1/397 (0.25%)  1 0/390 (0.00%)  0
Urinary tract obstruction  1  1/397 (0.25%)  1 2/390 (0.51%)  2
Urinoma  1  1/397 (0.25%)  1 0/390 (0.00%)  0
Vesicoureteric reflux  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Reproductive system and breast disorders     
Female genital tract fistula  1  2/397 (0.50%)  2 0/390 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Asthma  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Dyspnoea  1  1/397 (0.25%)  1 0/390 (0.00%)  0
Pneumonitis  1  0/397 (0.00%)  0 3/390 (0.77%)  3
Pulmonary embolism  1  5/397 (1.26%)  5 1/390 (0.26%)  1
Skin and subcutaneous tissue disorders     
Drug eruption  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Rash  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Rash maculo-papular  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Vascular disorders     
Arteriosclerosis  1  1/397 (0.25%)  1 0/390 (0.00%)  0
Deep vein thrombosis  1  3/397 (0.76%)  3 0/390 (0.00%)  0
Embolism  1  1/397 (0.25%)  1 0/390 (0.00%)  0
Hypertension  1  1/397 (0.25%)  1 0/390 (0.00%)  0
Hypotension  1  1/397 (0.25%)  1 0/390 (0.00%)  0
Lymphocele  1  0/397 (0.00%)  0 1/390 (0.26%)  1
Orthostatic hypotension  1  0/397 (0.00%)  0 1/390 (0.26%)  1
1
Term from vocabulary, MedDRA version 22.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
OBSERVATION ATEZOLIZUMAB
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   232/397 (58.44%)      324/390 (83.08%)    
Blood and lymphatic system disorders     
Anaemia  1  32/397 (8.06%)  34 42/390 (10.77%)  53
Endocrine disorders     
Hypothyroidism  1  0/397 (0.00%)  0 35/390 (8.97%)  38
Gastrointestinal disorders     
Abdominal pain  1  29/397 (7.30%)  32 31/390 (7.95%)  39
Constipation  1  39/397 (9.82%)  40 51/390 (13.08%)  60
Diarrhoea  1  25/397 (6.30%)  29 81/390 (20.77%)  103
Nausea  1  20/397 (5.04%)  21 52/390 (13.33%)  60
Vomiting  1  14/397 (3.53%)  16 26/390 (6.67%)  34
General disorders     
Asthenia  1  16/397 (4.03%)  16 35/390 (8.97%)  41
Chills  1  7/397 (1.76%)  9 23/390 (5.90%)  25
Fatigue  1  42/397 (10.58%)  49 89/390 (22.82%)  118
Oedema peripheral  1  23/397 (5.79%)  26 34/390 (8.72%)  38
Pyrexia  1  30/397 (7.56%)  43 71/390 (18.21%)  90
Infections and infestations     
Upper respiratory tract infection  1  18/397 (4.53%)  19 21/390 (5.38%)  27
Urinary tract infection  1  59/397 (14.86%)  84 63/390 (16.15%)  88
Investigations     
Alanine aminotransferase increased  1  7/397 (1.76%)  8 24/390 (6.15%)  32
Aspartate aminotransferase increased  1  5/397 (1.26%)  6 20/390 (5.13%)  25
Blood alkaline phosphatase increased  1  8/397 (2.02%)  8 20/390 (5.13%)  29
Blood creatinine increased  1  17/397 (4.28%)  20 37/390 (9.49%)  42
Metabolism and nutrition disorders     
Decreased appetite  1  20/397 (5.04%)  21 45/390 (11.54%)  54
Musculoskeletal and connective tissue disorders     
Arthralgia  1  24/397 (6.05%)  26 43/390 (11.03%)  48
Back pain  1  44/397 (11.08%)  54 26/390 (6.67%)  31
Myalgia  1  6/397 (1.51%)  8 21/390 (5.38%)  30
Pain in extremity  1  9/397 (2.27%)  9 22/390 (5.64%)  29
Nervous system disorders     
Dizziness  1  11/397 (2.77%)  11 20/390 (5.13%)  22
Headache  1  8/397 (2.02%)  8 35/390 (8.97%)  39
Respiratory, thoracic and mediastinal disorders     
Cough  1  23/397 (5.79%)  23 47/390 (12.05%)  60
Dyspnoea  1  7/397 (1.76%)  7 27/390 (6.92%)  33
Skin and subcutaneous tissue disorders     
Dry skin  1  2/397 (0.50%)  2 29/390 (7.44%)  30
Pruritus  1  10/397 (2.52%)  14 92/390 (23.59%)  113
Rash  1  5/397 (1.26%)  6 38/390 (9.74%)  48
1
Term from vocabulary, MedDRA version 22.1
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: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02450331    
Other Study ID Numbers: WO29636
2014-005603-25 ( EudraCT Number )
First Submitted: May 19, 2015
First Posted: May 21, 2015
Results First Submitted: October 21, 2020
Results First Posted: November 18, 2020
Last Update Posted: January 11, 2021