Trial Outcomes & Findings for Radiation Therapy and Chemotherapy in Treating Patients With Stage I Bladder Cancer (NCT NCT00981656)
NCT ID: NCT00981656
Last Updated: 2024-09-19
Results Overview
The number of participants who did not undergo a radical cystectomy within three years divided by the number of analyzed participants, presented with the 97.5% lower bound.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
Three years from registration
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
3DCRT + CT
Concurrent three-dimensional conformal radiation therapy (3DCRT) and radiosensitizing chemotherapy (CT) consisting of either cisplatin alone or the combination of mitomycin and 5-fluorouracil. Protocol treatment must begin with 15 weeks after a transurethral resection of the tumor (TURBT).
|
|---|---|
|
Overall Study
STARTED
|
37
|
|
Overall Study
Eligible and Started Study Treatment
|
34
|
|
Overall Study
COMPLETED
|
34
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
3DCRT + CT
Concurrent three-dimensional conformal radiation therapy (3DCRT) and radiosensitizing chemotherapy (CT) consisting of either cisplatin alone or the combination of mitomycin and 5-fluorouracil. Protocol treatment must begin with 15 weeks after a transurethral resection of the tumor (TURBT).
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|---|---|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Did not start protocol treatment
|
2
|
Baseline Characteristics
Radiation Therapy and Chemotherapy in Treating Patients With Stage I Bladder Cancer
Baseline characteristics by cohort
| Measure |
3DCRT + CT
n=34 Participants
Concurrent three-dimensional conformal radiation therapy (3DCRT) and radiosensitizing chemotherapy (CT) consisting of either cisplatin alone or the combination of mitomycin and 5-fluorouracil. Protocol treatment must begin with 15 weeks after a transurethral resection of the tumor (TURBT).
|
|---|---|
|
Age, Customized
Years · ≤ 59
|
4 Participants
n=5 Participants
|
|
Age, Customized
Years · 60-69
|
12 Participants
n=5 Participants
|
|
Age, Customized
Years · 70-79
|
14 Participants
n=5 Participants
|
|
Age, Customized
Years · ≥ 80
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Zubrod
0
|
29 Participants
n=5 Participants
|
|
Zubrod
1
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Three years from registrationPopulation: Eligible participants who started study treatment
The number of participants who did not undergo a radical cystectomy within three years divided by the number of analyzed participants, presented with the 97.5% lower bound.
Outcome measures
| Measure |
3DCRT + CT
n=34 Participants
Concurrent three-dimensional conformal radiation therapy (3DCRT) and radiosensitizing chemotherapy (CT) consisting of either cisplatin alone or the combination of mitomycin and 5-fluorouracil. Protocol treatment must begin with 15 weeks after a transurethral resection of the tumor (TURBT).
|
|---|---|
|
Percentage of Participants Free From Radical Cystectomy at 3 Years
|
88.2 percentage of participants
Interval 72.5 to
An upper bound was not calculated per protocol. (All alpha is used for the lower bound.)
|
SECONDARY outcome
Timeframe: Five years from registrationPopulation: Eligible participants who started study treatment
The number of participants who did not undergo a radical cystectomy within five years divided by the number of analyzed participants.
Outcome measures
| Measure |
3DCRT + CT
n=34 Participants
Concurrent three-dimensional conformal radiation therapy (3DCRT) and radiosensitizing chemotherapy (CT) consisting of either cisplatin alone or the combination of mitomycin and 5-fluorouracil. Protocol treatment must begin with 15 weeks after a transurethral resection of the tumor (TURBT).
|
|---|---|
|
Percentage of Participants Free From Radical Cystectomy at 5 Years
|
88.2 percentage of participants
Interval 72.5 to 96.7
|
SECONDARY outcome
Timeframe: From registration to three yearsPopulation: Eligible participants who started study treatment
Distant disease progression is defined as the first appearance of disease in a non-regional lymph node, solid organ or bone. Time to distant disease progression is defined as time from registration to the date of first distant disease progression, last known follow-up (censored), or death without distant disease progression (competing risk). Distant disease progression rate is estimated using the cumulative incidence method.
Outcome measures
| Measure |
3DCRT + CT
n=34 Participants
Concurrent three-dimensional conformal radiation therapy (3DCRT) and radiosensitizing chemotherapy (CT) consisting of either cisplatin alone or the combination of mitomycin and 5-fluorouracil. Protocol treatment must begin with 15 weeks after a transurethral resection of the tumor (TURBT).
|
|---|---|
|
Percent of Participants With Distant Disease Progression at 3 Years
|
12.3 percentage of participants
Interval 3.8 to 26.3
|
SECONDARY outcome
Timeframe: From registration to five yearsPopulation: Eligible participants who started study treatment
Distant disease progression is defined as the first appearance of disease in a non-regional lymph node, solid organ or bone. Time to distant disease progression is defined as time from registration to the date of first distant disease progression, last known follow-up (censored), or death without distant disease progression (competing risk). Distant disease progression rate is estimated using the cumulative incidence method.
Outcome measures
| Measure |
3DCRT + CT
n=34 Participants
Concurrent three-dimensional conformal radiation therapy (3DCRT) and radiosensitizing chemotherapy (CT) consisting of either cisplatin alone or the combination of mitomycin and 5-fluorouracil. Protocol treatment must begin with 15 weeks after a transurethral resection of the tumor (TURBT).
|
|---|---|
|
Percent of Participants With Distant Disease Progression at 5 Years
|
18.7 percentage of participants
Interval 7.4 to 34.0
|
SECONDARY outcome
Timeframe: From registration to three yearsPopulation: T-stage was not collected on follow-up forms and therefore this outcome measure could not be not analyzed.
Primary tumor stage T2 = tumor invades muscle; T3 = tumor invades perivesical tissue; T4 = tumor invades any of the following: prostate, uterus, vagina, pelvic wall, abdominal wall. Time to progression is defined as time from registration to the date of first progression, last known follow-up (censored), or death without tumor progression (competing risk). Tumor progression rates was to be estimated using the cumulative incidence method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From registration to five yearsPopulation: T-stage was not collected on follow-up forms and therefore this outcome measure cab not be not analyzed.
Primary tumor stage T2 = tumor invades muscle; T3 = tumor invades perivesical tissue; T4 = tumor invades any of the following: prostate, uterus, vagina, pelvic wall, abdominal wall. Time to progression is defined as time from registration to the date of first progression, last known follow-up (censored), or death without tumor progression (competing risk). Tumor progression rate was to be estimated using the cumulative incidence method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From registration to five yearsPopulation: Eligible participants who started study treatment
Time to death from bladder cancer is defined as time from registration to death from bladder cancer, last known follow-up (censored), or death from other cause (competing risk). More specifically, death absent a distant metastasis, death from non-bladder cancer, and death absent local recurrence comprise the competing risk. Death from bladder cancer rate is estimated using the cumulative incidence method.
Outcome measures
| Measure |
3DCRT + CT
n=34 Participants
Concurrent three-dimensional conformal radiation therapy (3DCRT) and radiosensitizing chemotherapy (CT) consisting of either cisplatin alone or the combination of mitomycin and 5-fluorouracil. Protocol treatment must begin with 15 weeks after a transurethral resection of the tumor (TURBT).
|
|---|---|
|
Percentage of Participants Who Have Died From Bladder Cancer at 5 Years (Disease-specific Survival)
|
25.1 percentage of participants
Interval 11.5 to 41.3
|
SECONDARY outcome
Timeframe: From registration to three yearsPopulation: Eligible participants who started study treatment
Overall survival time is defined as time from registration to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method.
Outcome measures
| Measure |
3DCRT + CT
n=34 Participants
Concurrent three-dimensional conformal radiation therapy (3DCRT) and radiosensitizing chemotherapy (CT) consisting of either cisplatin alone or the combination of mitomycin and 5-fluorouracil. Protocol treatment must begin with 15 weeks after a transurethral resection of the tumor (TURBT).
|
|---|---|
|
Percentage of Participants Alive at 3 Years
|
69.2 percentage of participants
Interval 53.3 to 85.2
|
SECONDARY outcome
Timeframe: From registration to five yearsPopulation: Eligible participants who started study treatment
Overall survival time is defined as time from registration to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method.
Outcome measures
| Measure |
3DCRT + CT
n=34 Participants
Concurrent three-dimensional conformal radiation therapy (3DCRT) and radiosensitizing chemotherapy (CT) consisting of either cisplatin alone or the combination of mitomycin and 5-fluorouracil. Protocol treatment must begin with 15 weeks after a transurethral resection of the tumor (TURBT).
|
|---|---|
|
Percentage of Participants Alive at 5 Years
|
56.4 percentage of participants
Interval 39.1 to 73.7
|
SECONDARY outcome
Timeframe: Adverse events are evaluated 8-10 weeks after end of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for 3 years, then annually. Maximum follow-up at time of reporting was 8.6 years.Population: Eligible participants who started study treatment
Common Terminology Criteria for Adverse Events (CTCAE) version 4 grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.
Outcome measures
| Measure |
3DCRT + CT
n=34 Participants
Concurrent three-dimensional conformal radiation therapy (3DCRT) and radiosensitizing chemotherapy (CT) consisting of either cisplatin alone or the combination of mitomycin and 5-fluorouracil. Protocol treatment must begin with 15 weeks after a transurethral resection of the tumor (TURBT).
|
|---|---|
|
Distribution of Participants by Highest Grade Adverse Event
Grade 3
|
20 Participants
|
|
Distribution of Participants by Highest Grade Adverse Event
Grade 4
|
2 Participants
|
|
Distribution of Participants by Highest Grade Adverse Event
Grade 1
|
2 Participants
|
|
Distribution of Participants by Highest Grade Adverse Event
Grade 2
|
9 Participants
|
|
Distribution of Participants by Highest Grade Adverse Event
Grade 5
|
0 Participants
|
SECONDARY outcome
Timeframe: From registration to three yearsPopulation: Eligible participants who started study treatment
Time to local recurrence is defined as time from registration to the date of first local recurrence, last known follow-up (censored), or death without local recurrence (competing risk). Local recurrence rate is estimated using the cumulative incidence method.
Outcome measures
| Measure |
3DCRT + CT
n=34 Participants
Concurrent three-dimensional conformal radiation therapy (3DCRT) and radiosensitizing chemotherapy (CT) consisting of either cisplatin alone or the combination of mitomycin and 5-fluorouracil. Protocol treatment must begin with 15 weeks after a transurethral resection of the tumor (TURBT).
|
|---|---|
|
Percentage of Participants With Local Recurrence at 3 Years
|
32.5 percentage of participants
Interval 17.4 to 48.6
|
SECONDARY outcome
Timeframe: Baseline and 3 yearsPopulation: Eligible participants who started study treatment and have baseline data
The American Urological Association Total symptom score measures the severity of enlarged prostate symptoms. Possible scores range from 0 to 35, with higher scores indicating worse symptoms.
Outcome measures
| Measure |
3DCRT + CT
n=32 Participants
Concurrent three-dimensional conformal radiation therapy (3DCRT) and radiosensitizing chemotherapy (CT) consisting of either cisplatin alone or the combination of mitomycin and 5-fluorouracil. Protocol treatment must begin with 15 weeks after a transurethral resection of the tumor (TURBT).
|
|---|---|
|
American Urological Association Total Symptom Score at Baseline and at 3 Years
Baseline
|
9.84 units on a scale
Standard Deviation 6.47
|
|
American Urological Association Total Symptom Score at Baseline and at 3 Years
Three years
|
12.00 units on a scale
Standard Deviation 9.25
|
Adverse Events
3DCRT + CT
Serious events: 7 serious events
Other events: 33 other events
Deaths: 15 deaths
Serious adverse events
| Measure |
3DCRT + CT
n=34 participants at risk
Concurrent three-dimensional conformal radiation therapy (3DCRT) and radiosensitizing chemotherapy (CT) consisting of either cisplatin alone or the combination of mitomycin and 5-fluorouracil. Protocol treatment must begin with 15 weeks after a transurethral resection of the tumor (TURBT).
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
2.9%
1/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
2.9%
1/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Gastrointestinal disorders
Mucositis oral
|
2.9%
1/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
General disorders
Fever
|
2.9%
1/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
General disorders
Non-cardiac chest pain
|
2.9%
1/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Infections and infestations
Lung infection
|
2.9%
1/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Infections and infestations
Tooth infection
|
2.9%
1/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Infections and infestations
Urinary tract infection
|
5.9%
2/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Investigations
Neutrophil count decreased
|
2.9%
1/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.9%
1/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Psychiatric disorders
Anxiety
|
2.9%
1/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Psychiatric disorders
Depression
|
2.9%
1/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Renal and urinary disorders
Renal calculi
|
2.9%
1/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Renal and urinary disorders
Urinary frequency
|
2.9%
1/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
2.9%
1/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Vascular disorders
Hypertension
|
2.9%
1/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Vascular disorders
Thromboembolic event
|
2.9%
1/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Vascular disorders
Vascular disorders - Other, specify
|
2.9%
1/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
Other adverse events
| Measure |
3DCRT + CT
n=34 participants at risk
Concurrent three-dimensional conformal radiation therapy (3DCRT) and radiosensitizing chemotherapy (CT) consisting of either cisplatin alone or the combination of mitomycin and 5-fluorouracil. Protocol treatment must begin with 15 weeks after a transurethral resection of the tumor (TURBT).
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
58.8%
20/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
5.9%
2/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.9%
2/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
11.8%
4/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
17/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Gastrointestinal disorders
Diarrhea
|
61.8%
21/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.8%
3/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Gastrointestinal disorders
Dysphagia
|
5.9%
2/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Gastrointestinal disorders
Flatulence
|
14.7%
5/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
17.6%
6/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Gastrointestinal disorders
Hemorrhoids
|
11.8%
4/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Gastrointestinal disorders
Mucositis oral
|
8.8%
3/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Gastrointestinal disorders
Nausea
|
41.2%
14/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
5.9%
2/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
General disorders
Chills
|
11.8%
4/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
General disorders
Edema limbs
|
17.6%
6/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
General disorders
Fatigue
|
82.4%
28/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
General disorders
Fever
|
11.8%
4/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
General disorders
Pain
|
17.6%
6/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Infections and infestations
Bladder infection
|
5.9%
2/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Infections and infestations
Mucosal infection
|
5.9%
2/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Infections and infestations
Urinary tract infection
|
14.7%
5/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
5.9%
2/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Investigations
Alanine aminotransferase increased
|
17.6%
6/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Investigations
Alkaline phosphatase increased
|
5.9%
2/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Investigations
Aspartate aminotransferase increased
|
8.8%
3/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Investigations
Blood bilirubin increased
|
5.9%
2/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Investigations
Creatinine increased
|
35.3%
12/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Investigations
INR increased
|
5.9%
2/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Investigations
Investigations - Other, specify
|
5.9%
2/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Investigations
Lymphocyte count decreased
|
47.1%
16/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Investigations
Neutrophil count decreased
|
11.8%
4/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Investigations
Platelet count decreased
|
41.2%
14/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Investigations
Weight loss
|
11.8%
4/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Investigations
White blood cell decreased
|
35.3%
12/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
14.7%
5/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
11.8%
4/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
44.1%
15/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
11.8%
4/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
5.9%
2/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
23.5%
8/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
20.6%
7/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
14.7%
5/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
20.6%
7/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
11.8%
4/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
8.8%
3/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.8%
3/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
5.9%
2/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
5.9%
2/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
11.8%
4/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
2/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.7%
5/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Nervous system disorders
Dizziness
|
11.8%
4/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
11.8%
4/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.8%
3/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Psychiatric disorders
Agitation
|
5.9%
2/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Psychiatric disorders
Anxiety
|
11.8%
4/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Psychiatric disorders
Depression
|
5.9%
2/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Psychiatric disorders
Insomnia
|
14.7%
5/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Renal and urinary disorders
Bladder spasm
|
14.7%
5/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Renal and urinary disorders
Cystitis noninfective
|
23.5%
8/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Renal and urinary disorders
Hematuria
|
32.4%
11/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
35.3%
12/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Renal and urinary disorders
Urinary frequency
|
70.6%
24/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Renal and urinary disorders
Urinary incontinence
|
14.7%
5/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Renal and urinary disorders
Urinary retention
|
8.8%
3/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Renal and urinary disorders
Urinary tract pain
|
14.7%
5/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Renal and urinary disorders
Urinary urgency
|
32.4%
11/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
20.6%
7/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.8%
3/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
35.3%
12/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
5.9%
2/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
8.8%
3/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.8%
3/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.9%
2/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.9%
2/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
8.8%
3/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Vascular disorders
Hypertension
|
11.8%
4/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Vascular disorders
Hypotension
|
8.8%
3/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
|
Vascular disorders
Thromboembolic event
|
8.8%
3/34 • Adverse events are evaluated 8-10 weeks after completion of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for three years, then annually. Maximum follow-up at time of reporting was 8.6 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
- Publication restrictions are in place
Restriction type: OTHER