Trial Outcomes & Findings for Atezolizumab in Treating Patients With Recurrent BCG-Unresponsive Non-muscle Invasive Bladder Cancer (NCT NCT02844816)
NCT ID: NCT02844816
Last Updated: 2025-05-22
Results Overview
To estimate complete response at 25 weeks after registration for those with a CIS component. Complete Response (CR) is defined as negative biopsy for high grade disease at Week 25 (± 7 days) for the subset of patients with a CIS component at study entry, according to local pathology call. In addition, patients with a CIS component who undergo negative biopsy at Week 13 for suspicious cystoscopy and or positive cytology and have cystoscopy not suspicious for cancer and cytology not positive for malignant cells at Week 25 do not require repeat biopsy at Week 25 and will be considered to have a complete response at Week 13 and will also be counted as having a complete response at Week 25.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
172 participants
Primary outcome timeframe
At 25 weeks
Results posted on
2025-05-22
Participant Flow
172 participants were registered for the study: 101 on the CIS +/ Ta/T1 stratification and 71 on the Ta/T1 (without CIS) stratification. Six participants did not receive protocol therapy, leaving 166 participants were included in the safety analysis population: 96 on the CIS +/ Ta/T1 stratification and 70 on the Ta/T1 (without CIS) stratification. 37 participants were ineligible, leaving 129 eligible and evaluable total participants.
Participant milestones
| Measure |
Atezolizumab - CIS +/ Ta/T1
Patients with CIS +/ Ta/T1 histology at baseline. Patients receive atezolizumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 17 cycles (51 weeks) in the absence of disease progression or unacceptable toxicity.
Atezolizumab: Given IV
|
Atezolizumab - Ta/T1 (Without CIS)
Patients with Ta/T1 (without CIS) histology at baseline. Patients receive atezolizumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 17 cycles (51 weeks) in the absence of disease progression or unacceptable toxicity.
Atezolizumab: Given IV
|
|---|---|---|
|
Overall Study
STARTED
|
101
|
71
|
|
Overall Study
Safety Analysis Population
|
96
|
70
|
|
Overall Study
Eligible and Evaluable
|
74
|
55
|
|
Overall Study
COMPLETED
|
13
|
20
|
|
Overall Study
NOT COMPLETED
|
88
|
51
|
Reasons for withdrawal
| Measure |
Atezolizumab - CIS +/ Ta/T1
Patients with CIS +/ Ta/T1 histology at baseline. Patients receive atezolizumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 17 cycles (51 weeks) in the absence of disease progression or unacceptable toxicity.
Atezolizumab: Given IV
|
Atezolizumab - Ta/T1 (Without CIS)
Patients with Ta/T1 (without CIS) histology at baseline. Patients receive atezolizumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 17 cycles (51 weeks) in the absence of disease progression or unacceptable toxicity.
Atezolizumab: Given IV
|
|---|---|---|
|
Overall Study
No protocol treatment received
|
5
|
1
|
|
Overall Study
Ineligible
|
22
|
15
|
|
Overall Study
Participant refusal
|
5
|
5
|
|
Overall Study
Adverse Event
|
5
|
4
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Disease progression/recurrence
|
50
|
24
|
|
Overall Study
Physician Decision
|
1
|
1
|
Baseline Characteristics
Atezolizumab in Treating Patients With Recurrent BCG-Unresponsive Non-muscle Invasive Bladder Cancer
Baseline characteristics by cohort
| Measure |
Atezolizumab - CIS +/ Ta/T1
n=74 Participants
Patients with CIS +/ Ta/T1 histology at baseline. Patients receive atezolizumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 17 cycles (51 weeks) in the absence of disease progression or unacceptable toxicity.
Atezolizumab: Given IV
|
Atezolizumab - Ta/T1 (Without CIS)
n=55 Participants
Patients with Ta/T1 (without CIS) histology at baseline. Patients receive atezolizumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 17 cycles (51 weeks) in the absence of disease progression or unacceptable toxicity.
Atezolizumab: Given IV
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73 years
n=93 Participants
|
74 years
n=4 Participants
|
74 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=93 Participants
|
46 Participants
n=4 Participants
|
108 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
70 Participants
n=93 Participants
|
49 Participants
n=4 Participants
|
119 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other, unknown
|
4 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Zubrod Performance Status Score
0
|
57 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
93 Participants
n=27 Participants
|
|
Zubrod Performance Status Score
1
|
17 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
Zubrod Performance Status Score
2
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Histology
CIS only
|
43 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
43 Participants
n=27 Participants
|
|
Histology
CIS + Ta
|
14 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Histology
CIS + T1
|
13 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Histology
CIS + Ta + T1
|
4 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Histology
Ta only
|
0 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
Histology
T1 only
|
0 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Histology
Ta + T1
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Median Prior BCG Installations
|
12 BCG instillations
n=93 Participants
|
12 BCG instillations
n=4 Participants
|
12 BCG instillations
n=27 Participants
|
|
Median Time Since Last BCG
|
154 Days
n=93 Participants
|
127 Days
n=4 Participants
|
136 Days
n=27 Participants
|
|
Reason for not Undergoing Cystectomy
Ineligible
|
5 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Reason for not Undergoing Cystectomy
Patient choice
|
69 Participants
n=93 Participants
|
48 Participants
n=4 Participants
|
117 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: At 25 weeksPopulation: The analysis population included the 74 participants that had CIS +/ Ta/T1 histology, received protocol therapy, and were eligible for the study.
To estimate complete response at 25 weeks after registration for those with a CIS component. Complete Response (CR) is defined as negative biopsy for high grade disease at Week 25 (± 7 days) for the subset of patients with a CIS component at study entry, according to local pathology call. In addition, patients with a CIS component who undergo negative biopsy at Week 13 for suspicious cystoscopy and or positive cytology and have cystoscopy not suspicious for cancer and cytology not positive for malignant cells at Week 25 do not require repeat biopsy at Week 25 and will be considered to have a complete response at Week 13 and will also be counted as having a complete response at Week 25.
Outcome measures
| Measure |
Atezolizumab - CIS +/ Ta/T1
n=74 Participants
Patients with CIS +/ Ta/T1 histology at baseline. Patients receive atezolizumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 17 cycles (51 weeks) in the absence of disease progression or unacceptable toxicity.
Atezolizumab: Given IV
|
Atezolizumab - Ta/T1 (Without CIS)
Patients with Ta/T1 (without CIS) histology at baseline. Patients receive atezolizumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 17 cycles (51 weeks) in the absence of disease progression or unacceptable toxicity.
Atezolizumab: Given IV
|
|---|---|---|
|
Complete Response (CR) Rate in the Subset of Patients With Carcinoma in Situ (CIS)
|
27 percentage of participants
Interval 17.0 to 38.0
|
—
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: The two primary outcomes were hierarchical co-primary endpoints - CR rate in the CIS subset and 18-month EFS for all patients. The protocol states that EFS in all patients would only be evaluated if the CR rate in evaluable patients in the CIS subset was statistically significant. Because the primary endpoint of CR at 6 months for CIS patients did not meet pre-specified criteria, we did not conduct the analysis of EFS in all patients so there are no results to report for this endpoint.
To evaluate event-free survival at 18 months in patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer (Ta/T1/CIS) treated with atezolizumab. Event-Free Survival is defined as time from date of registration to first documentation of event. Participants last known to be alive and not to have recurred are censored at the date of last contact. An event was defined as the first occurrence of any of the following: biopsy-proven high-grade bladder cancer (including persistent CIS at 3 and/or 6 months); high-grade upper tract urothelial carcinoma; high-grade urothelial carcinoma of the prostatic urethra; muscle-invasive disease; clinical evidence of metastatic disease; or death due to any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 18 monthsPopulation: Only participants who were eligible and received at least one dose or protocol therapy were analyzed.
To evaluate event-free survival at 18 months in the subset of participants with papillary cancer (Ta/T1) treated with atezolizumab. Event-Free Survival is defined as time from date of registration to first documentation of event. Participants last known to be alive and not to have recurred are censored at the date of last contact. An event was defined as the first occurrence of any of the following: biopsy-proven high-grade bladder cancer (including persistent CIS at 3 and/or 6 months); high-grade upper tract urothelial carcinoma; high-grade urothelial carcinoma of the prostatic urethra; muscle-invasive disease; clinical evidence of metastatic disease; or death due to any cause.
Outcome measures
| Measure |
Atezolizumab - CIS +/ Ta/T1
n=55 Participants
Patients with CIS +/ Ta/T1 histology at baseline. Patients receive atezolizumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 17 cycles (51 weeks) in the absence of disease progression or unacceptable toxicity.
Atezolizumab: Given IV
|
Atezolizumab - Ta/T1 (Without CIS)
Patients with Ta/T1 (without CIS) histology at baseline. Patients receive atezolizumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 17 cycles (51 weeks) in the absence of disease progression or unacceptable toxicity.
Atezolizumab: Given IV
|
|---|---|---|
|
Event-free Survival (EFS) in the Ta/T1 Subset
|
49 percentage of participants
Interval 34.0 to 57.0
|
—
|
SECONDARY outcome
Timeframe: 18 monthsTo evaluate progression-free survival at 18 months in all eligible and evaluable participants. Progression-free survival (PFS) is defined as the time from registration to first evidence of biopsy-proven muscle-invasive bladder cancer (T\>=2), nodal or distant metastasis, or death from any cause. Participants without an event were censored at the date of their last cystoscopy. Estimated using Kaplan-Meier.
Outcome measures
| Measure |
Atezolizumab - CIS +/ Ta/T1
n=129 Participants
Patients with CIS +/ Ta/T1 histology at baseline. Patients receive atezolizumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 17 cycles (51 weeks) in the absence of disease progression or unacceptable toxicity.
Atezolizumab: Given IV
|
Atezolizumab - Ta/T1 (Without CIS)
Patients with Ta/T1 (without CIS) histology at baseline. Patients receive atezolizumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 17 cycles (51 weeks) in the absence of disease progression or unacceptable toxicity.
Atezolizumab: Given IV
|
|---|---|---|
|
Progression-free Survival (PFS)
|
82 percentage of participants
Interval 74.0 to 88.0
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: This study is a single arm study and while other outcome measures compared the two strata (CIS +/ Ta/T1 and Ta/T1 (Without CIS)), the population for this outcome measure is unstratified and includes all 33 participants across both strata that underwent a radical cystectomy.
Time to cystectomy is defined as time from discontinuation of protocol therapy to time of cystectomy.
Outcome measures
| Measure |
Atezolizumab - CIS +/ Ta/T1
n=33 Participants
Patients with CIS +/ Ta/T1 histology at baseline. Patients receive atezolizumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 17 cycles (51 weeks) in the absence of disease progression or unacceptable toxicity.
Atezolizumab: Given IV
|
Atezolizumab - Ta/T1 (Without CIS)
Patients with Ta/T1 (without CIS) histology at baseline. Patients receive atezolizumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 17 cycles (51 weeks) in the absence of disease progression or unacceptable toxicity.
Atezolizumab: Given IV
|
|---|---|---|
|
Time to Cystectomy
|
106 days
Interval 33.0 to 1233.0
|
—
|
SECONDARY outcome
Timeframe: 3 yearsTo evaluate bladder cancer-specific survival at 3 years in all eligible and evaluable participants. Bladder cancer-specific survival is defined as the time from registration to death due to bladder cancer. Participants without bladder cancer death are censored at last contact date or date of non-bladder cancer death. Estimated using Kaplan-Meier.
Outcome measures
| Measure |
Atezolizumab - CIS +/ Ta/T1
n=129 Participants
Patients with CIS +/ Ta/T1 histology at baseline. Patients receive atezolizumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 17 cycles (51 weeks) in the absence of disease progression or unacceptable toxicity.
Atezolizumab: Given IV
|
Atezolizumab - Ta/T1 (Without CIS)
Patients with Ta/T1 (without CIS) histology at baseline. Patients receive atezolizumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 17 cycles (51 weeks) in the absence of disease progression or unacceptable toxicity.
Atezolizumab: Given IV
|
|---|---|---|
|
Bladder Cancer-Specific Survival
|
91 percentage of participants
Interval 83.0 to 95.0
|
—
|
SECONDARY outcome
Timeframe: 3 yearsOverall survival (OS) is defined as the time from registration to the date of death due to any cause. Participants last known to be alive are censored at the date of last contact.
Outcome measures
| Measure |
Atezolizumab - CIS +/ Ta/T1
n=74 Participants
Patients with CIS +/ Ta/T1 histology at baseline. Patients receive atezolizumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 17 cycles (51 weeks) in the absence of disease progression or unacceptable toxicity.
Atezolizumab: Given IV
|
Atezolizumab - Ta/T1 (Without CIS)
n=55 Participants
Patients with Ta/T1 (without CIS) histology at baseline. Patients receive atezolizumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 17 cycles (51 weeks) in the absence of disease progression or unacceptable toxicity.
Atezolizumab: Given IV
|
|---|---|---|
|
Three-Year Overall Survival
|
80 percentage of paticipants
Interval 70.0 to 90.0
|
79 percentage of paticipants
Interval 68.0 to 91.0
|
Adverse Events
Atezolizumab
Serious events: 42 serious events
Other events: 161 other events
Deaths: 25 deaths
Serious adverse events
| Measure |
Atezolizumab
n=166 participants at risk
Patients receive atezolizumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 17 cycles (51 weeks) in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.8%
3/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Cardiac disorders
Atrial fibrillation
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Cardiac disorders
Heart failure
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Cardiac disorders
Myocardial infarction
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Endocrine disorders
Endocrine disorders-Other
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Endocrine disorders
Hyperthyroidism
|
2.4%
4/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Endocrine disorders
Hypothyroidism
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Gastrointestinal disorders
Abdominal pain
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Gastrointestinal disorders
Colitis
|
1.2%
2/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Gastrointestinal disorders
Diarrhea
|
1.2%
2/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Gastrointestinal disorders
Esophagitis
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Gastrointestinal disorders
Gastritis
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Gastrointestinal disorders
Ileus
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Gastrointestinal disorders
Nausea
|
1.8%
3/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
3/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
General disorders
Chills
|
1.2%
2/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
General disorders
Edema limbs
|
1.2%
2/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
General disorders
Fatigue
|
1.2%
2/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
General disorders
Fever
|
1.2%
2/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
General disorders
Flu like symptoms
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Hepatobiliary disorders
Hepatic failure
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Immune system disorders
Anaphylaxis
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Infections and infestations
Device related infection
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Infections and infestations
Enterocolitis infectious
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Infections and infestations
Infections and infestations-Other
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Infections and infestations
Sepsis
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Infections and infestations
Skin infection
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Infections and infestations
Urinary tract infection
|
2.4%
4/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Injury, poisoning and procedural complications
Fall
|
1.2%
2/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Injury, poisoning and procedural complications
Fracture
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Investigations
Alanine aminotransferase increased
|
2.4%
4/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Investigations
Aspartate aminotransferase increased
|
1.8%
3/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Investigations
CPK increased
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Investigations
Creatinine increased
|
2.4%
4/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Investigations
Lipase increased
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Investigations
Platelet count decreased
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Metabolism and nutrition disorders
Acidosis
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Metabolism and nutrition disorders
Anorexia
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
2/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.2%
2/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.4%
4/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tiss disorder - Other
|
1.2%
2/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Nervous system disorders
Encephalopathy
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Nervous system disorders
Nervous system disorders-Other
|
1.2%
2/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Nervous system disorders
Syncope
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Psychiatric disorders
Delirium
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Renal and urinary disorders
Acute kidney injury
|
3.0%
5/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Renal and urinary disorders
Hematuria
|
3.6%
6/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Renal and urinary disorders
Renal and urinary disorders-Other
|
1.2%
2/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Renal and urinary disorders
Urinary retention
|
1.2%
2/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.8%
3/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Surgical and medical procedures
Surgical and medical procedures-Other
|
0.60%
1/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Vascular disorders
Hypertension
|
1.2%
2/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
Other adverse events
| Measure |
Atezolizumab
n=166 participants at risk
Patients receive atezolizumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 17 cycles (51 weeks) in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
23.5%
39/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Endocrine disorders
Hyperthyroidism
|
6.0%
10/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Endocrine disorders
Hypothyroidism
|
9.6%
16/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Gastrointestinal disorders
Abdominal pain
|
7.8%
13/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Gastrointestinal disorders
Constipation
|
14.5%
24/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Gastrointestinal disorders
Diarrhea
|
27.1%
45/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Gastrointestinal disorders
Nausea
|
13.9%
23/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
General disorders
Chills
|
6.6%
11/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
General disorders
Edema limbs
|
7.8%
13/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
General disorders
Fatigue
|
50.6%
84/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
General disorders
Fever
|
9.0%
15/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
General disorders
Flu like symptoms
|
5.4%
9/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
General disorders
General disorders and admin site conditions - Other
|
7.2%
12/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
General disorders
Pain
|
9.0%
15/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Infections and infestations
Upper respiratory infection
|
6.6%
11/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Infections and infestations
Urinary tract infection
|
12.0%
20/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Injury, poisoning and procedural complications
Bruising
|
5.4%
9/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Injury, poisoning and procedural complications
Fall
|
6.0%
10/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Investigations
Alanine aminotransferase increased
|
14.5%
24/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Investigations
Alkaline phosphatase increased
|
12.0%
20/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Investigations
Aspartate aminotransferase increased
|
18.7%
31/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Investigations
Blood bilirubin increased
|
6.6%
11/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Investigations
Creatinine increased
|
17.5%
29/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Investigations
Investigations-Other
|
7.2%
12/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Investigations
Lymphocyte count decreased
|
11.4%
19/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Investigations
Platelet count decreased
|
8.4%
14/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Investigations
White blood cell decreased
|
8.4%
14/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Metabolism and nutrition disorders
Anorexia
|
12.0%
20/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
6.6%
11/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
22.3%
37/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.8%
13/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
10.2%
17/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.0%
10/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.6%
11/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.3%
27/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.4%
19/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.3%
22/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tiss disorder - Other
|
5.4%
9/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.4%
14/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.4%
9/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Nervous system disorders
Dizziness
|
6.6%
11/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Nervous system disorders
Headache
|
14.5%
24/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Psychiatric disorders
Insomnia
|
6.0%
10/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Renal and urinary disorders
Hematuria
|
12.0%
20/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Renal and urinary disorders
Renal and urinary disorders-Other
|
6.6%
11/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Renal and urinary disorders
Urinary frequency
|
9.0%
15/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Renal and urinary disorders
Urinary tract pain
|
6.0%
10/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Renal and urinary disorders
Urinary urgency
|
5.4%
9/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.9%
33/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
15.7%
26/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.4%
14/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.4%
14/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.3%
27/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
12.7%
21/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
14.5%
24/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
|
Vascular disorders
Hypertension
|
16.9%
28/166 • Duration of treatment and follow-up until death or 5 years after registration
Adverse events (AEs) are reported by CTCAE Version 4.0. 166 participants received at least one dose of protocol treatment and were assessed for adverse events and all-cause mortality
|
Additional Information
SWOG Statistician
SWOG Statistics and Data Management Center
Phone: 2066674623
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60