Trial Outcomes & Findings for Nutrition Therapy in Improving Immune System in Patients With Bladder Cancer That Can Be Removed by Surgery (NCT NCT03757949)
NCT ID: NCT03757949
Last Updated: 2026-05-04
Results Overview
A post-operative complication is defined as a binary indicator variable indicating whether the patient experienced any complication (any/none; Clavien-Dindo grades I-V). The primary analysis will be based on a multivariable logistic regression under intent-totreat among all randomized patients, irrespective of their eligibility status, adjusting for the specified stratification factors: a. Diversion type (neobladder versus \[vs.\] ileal conduit); b. Prior neoadjuvant chemotherapy (any vs. none); and c. Nutrition status (well nourished vs. moderate malnutrition). A Fisher's exact test will also be conducted to establish whether the results are sensitive to model assumptions. A single interim analysis for efficacy will be conducted when 50% of patients achieve their endpoint at the alpha=0.005 level. Accordingly, the final analysis will be conducted at the alpha=0.045 level. A separate analysis among all eligible randomized patients will also be conducted.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
203 participants
Primary outcome timeframe
Up to 30 days post surgery
Results posted on
2026-05-04
Participant Flow
Participant milestones
| Measure |
Arm I (SIM)
Patients receive SIM PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0.
Laboratory Biomarker Analysis: Correlative studies
Nutritional Intervention: Receive SIM PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm II (Placebo)
ARM II: Patients receive placebo PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0.
Laboratory Biomarker Analysis: Correlative studies
Placebo Administration: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Overall Study
STARTED
|
99
|
104
|
|
Overall Study
COMPLETED
|
90
|
88
|
|
Overall Study
NOT COMPLETED
|
9
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nutrition Therapy in Improving Immune System in Patients With Bladder Cancer That Can Be Removed by Surgery
Baseline characteristics by cohort
| Measure |
Arm I (SIM)
n=99 Participants
Patients receive SIM PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0.
Laboratory Biomarker Analysis: Correlative studies
Nutritional Intervention: Receive SIM PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm II (Placebo)
n=104 Participants
ARM II: Patients receive placebo PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0.
Laboratory Biomarker Analysis: Correlative studies
Placebo Administration: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Total
n=203 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=54 Participants
|
32 Participants
n=60 Participants
|
65 Participants
n=114 Participants
|
|
Age, Categorical
>=65 years
|
66 Participants
n=54 Participants
|
72 Participants
n=60 Participants
|
138 Participants
n=114 Participants
|
|
Age, Continuous
|
68 years
n=54 Participants
|
69.45 years
n=60 Participants
|
68.8 years
n=114 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=54 Participants
|
19 Participants
n=60 Participants
|
41 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
77 Participants
n=54 Participants
|
85 Participants
n=60 Participants
|
162 Participants
n=114 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=54 Participants
|
2 Participants
n=60 Participants
|
6 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=54 Participants
|
6 Participants
n=60 Participants
|
10 Participants
n=114 Participants
|
|
Race (NIH/OMB)
White
|
68 Participants
n=54 Participants
|
79 Participants
n=60 Participants
|
147 Participants
n=114 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
22 Participants
n=54 Participants
|
17 Participants
n=60 Participants
|
39 Participants
n=114 Participants
|
|
Region of Enrollment
United States
|
99 participants
n=54 Participants
|
104 participants
n=60 Participants
|
203 participants
n=114 Participants
|
PRIMARY outcome
Timeframe: Up to 30 days post surgeryPopulation: Participants who are evaluable at day 30
A post-operative complication is defined as a binary indicator variable indicating whether the patient experienced any complication (any/none; Clavien-Dindo grades I-V). The primary analysis will be based on a multivariable logistic regression under intent-totreat among all randomized patients, irrespective of their eligibility status, adjusting for the specified stratification factors: a. Diversion type (neobladder versus \[vs.\] ileal conduit); b. Prior neoadjuvant chemotherapy (any vs. none); and c. Nutrition status (well nourished vs. moderate malnutrition). A Fisher's exact test will also be conducted to establish whether the results are sensitive to model assumptions. A single interim analysis for efficacy will be conducted when 50% of patients achieve their endpoint at the alpha=0.005 level. Accordingly, the final analysis will be conducted at the alpha=0.045 level. A separate analysis among all eligible randomized patients will also be conducted.
Outcome measures
| Measure |
Arm II (Placebo)
n=88 Participants
ARM II: Patients receive placebo PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0.
Laboratory Biomarker Analysis: Correlative studies
Placebo Administration: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm I (SIM)
n=90 Participants
Patients receive SIM PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0.
Laboratory Biomarker Analysis: Correlative studies
Nutritional Intervention: Receive SIM PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Post-operative Complications (30 Days)
|
51 Participants
|
56 Participants
|
SECONDARY outcome
Timeframe: Within 90 days after scheduled RCPopulation: Patients evaluable at 90 days
Late-phase post-operative complications within 90 days after scheduled RC
Outcome measures
| Measure |
Arm II (Placebo)
n=88 Participants
ARM II: Patients receive placebo PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0.
Laboratory Biomarker Analysis: Correlative studies
Placebo Administration: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm I (SIM)
n=90 Participants
Patients receive SIM PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0.
Laboratory Biomarker Analysis: Correlative studies
Nutritional Intervention: Receive SIM PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Post-Op Complications (90 Days)
Fever
|
2 participants
|
0 participants
|
|
Post-Op Complications (90 Days)
Metabolic acidosis
|
0 participants
|
5 participants
|
SECONDARY outcome
Timeframe: 30 days post-opNumber of post-operative infections
Outcome measures
| Measure |
Arm II (Placebo)
n=88 Participants
ARM II: Patients receive placebo PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0.
Laboratory Biomarker Analysis: Correlative studies
Placebo Administration: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm I (SIM)
n=90 Participants
Patients receive SIM PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0.
Laboratory Biomarker Analysis: Correlative studies
Nutritional Intervention: Receive SIM PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Infections
Superficial wound infection
|
5 number of infections
|
5 number of infections
|
|
Infections
Deep wound infection
|
2 number of infections
|
0 number of infections
|
|
Infections
Urinary tract infection
|
15 number of infections
|
29 number of infections
|
SECONDARY outcome
Timeframe: 30 days post opOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 days post-opHigh grade complications 30 days post-op, where high grade is Clavien-Dindo scores III-V
Outcome measures
| Measure |
Arm II (Placebo)
n=88 Participants
ARM II: Patients receive placebo PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0.
Laboratory Biomarker Analysis: Correlative studies
Placebo Administration: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm I (SIM)
n=90 Participants
Patients receive SIM PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0.
Laboratory Biomarker Analysis: Correlative studies
Nutritional Intervention: Receive SIM PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
High Grade Post-Op Complications
|
7 number of complications
|
11 number of complications
|
SECONDARY outcome
Timeframe: 30 days post-opCount of participants that were readmitted to hospital within 30 days post-op.
Outcome measures
| Measure |
Arm II (Placebo)
n=88 Participants
ARM II: Patients receive placebo PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0.
Laboratory Biomarker Analysis: Correlative studies
Placebo Administration: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm I (SIM)
n=90 Participants
Patients receive SIM PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0.
Laboratory Biomarker Analysis: Correlative studies
Nutritional Intervention: Receive SIM PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Readmission Rates
|
19 participants
|
30 participants
|
SECONDARY outcome
Timeframe: 30 days post opOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsDisease free survival is defined as time from surgery to documented recurrence or death from any cause. The number reported is the number of participants who survived two years without documented recurrence.
Outcome measures
| Measure |
Arm II (Placebo)
n=88 Participants
ARM II: Patients receive placebo PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0.
Laboratory Biomarker Analysis: Correlative studies
Placebo Administration: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm I (SIM)
n=90 Participants
Patients receive SIM PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0.
Laboratory Biomarker Analysis: Correlative studies
Nutritional Intervention: Receive SIM PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
2-Year Disease Free Survival
|
59 participants
|
70 participants
|
Adverse Events
Arm I (SIM)
Serious events: 2 serious events
Other events: 68 other events
Deaths: 9 deaths
Arm II (Placebo)
Serious events: 2 serious events
Other events: 67 other events
Deaths: 17 deaths
Serious adverse events
| Measure |
Arm I (SIM)
n=91 participants at risk
Patients receive SIM PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0.
Laboratory Biomarker Analysis: Correlative studies
Nutritional Intervention: Receive SIM PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm II (Placebo)
n=88 participants at risk
ARM II: Patients receive placebo PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0.
Laboratory Biomarker Analysis: Correlative studies
Placebo Administration: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/91 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
2.3%
2/88 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/91 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
1.1%
1/88 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
|
Infections and infestations
Kidney infection
|
1.1%
1/91 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
0.00%
0/88 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
|
Infections and infestations
Sepsis
|
1.1%
1/91 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
0.00%
0/88 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
|
Injury, poisoning and procedural complications
Postoperative thoracic procedure complication
|
0.00%
0/91 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
1.1%
1/88 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/91 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
1.1%
1/88 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
Other adverse events
| Measure |
Arm I (SIM)
n=91 participants at risk
Patients receive SIM PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0.
Laboratory Biomarker Analysis: Correlative studies
Nutritional Intervention: Receive SIM PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm II (Placebo)
n=88 participants at risk
ARM II: Patients receive placebo PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0.
Laboratory Biomarker Analysis: Correlative studies
Placebo Administration: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
19.8%
18/91 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
23.9%
21/88 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
6.6%
6/91 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
5.7%
5/88 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
|
Cardiac disorders
Sinus tachycardia
|
5.5%
5/91 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
4.5%
4/88 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.5%
5/91 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
1.1%
1/88 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
|
Gastrointestinal disorders
Abdominal pain
|
17.6%
16/91 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
19.3%
17/88 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
|
Gastrointestinal disorders
Bloating
|
8.8%
8/91 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
8.0%
7/88 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
|
Gastrointestinal disorders
Constipation
|
16.5%
15/91 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
13.6%
12/88 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
|
Gastrointestinal disorders
Diarrhea
|
18.7%
17/91 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
10.2%
9/88 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
|
Gastrointestinal disorders
Gastrointestinal disorders-Other
|
4.4%
4/91 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
8.0%
7/88 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
|
Gastrointestinal disorders
Ileus
|
6.6%
6/91 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
10.2%
9/88 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
|
Gastrointestinal disorders
Nausea
|
30.8%
28/91 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
29.5%
26/88 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
|
Gastrointestinal disorders
Vomiting
|
22.0%
20/91 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
15.9%
14/88 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
|
General disorders
Chills
|
6.6%
6/91 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
2.3%
2/88 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
|
General disorders
Edema limbs
|
5.5%
5/91 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
8.0%
7/88 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
|
General disorders
Fatigue
|
15.4%
14/91 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
18.2%
16/88 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
|
General disorders
Fever
|
16.5%
15/91 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
4.5%
4/88 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
|
General disorders
Pain
|
16.5%
15/91 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
8.0%
7/88 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
|
Infections and infestations
Sepsis
|
5.5%
5/91 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
3.4%
3/88 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
|
Infections and infestations
Urinary tract infection
|
20.9%
19/91 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
11.4%
10/88 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
|
Investigations
Creatinine increased
|
11.0%
10/91 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
12.5%
11/88 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
|
Metabolism and nutrition disorders
Anorexia
|
6.6%
6/91 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
5.7%
5/88 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
8.8%
8/91 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
14.8%
13/88 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
5.5%
5/91 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
2.3%
2/88 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
8.8%
8/91 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
6.8%
6/88 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.6%
6/91 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
6.8%
6/88 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
8.8%
8/91 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
5.7%
5/88 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.8%
8/91 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
4.5%
4/88 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.6%
6/91 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
4.5%
4/88 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders-Other
|
6.6%
6/91 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
1.1%
1/88 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.6%
6/91 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
4.5%
4/88 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
|
Nervous system disorders
Dizziness
|
7.7%
7/91 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
3.4%
3/88 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
|
Renal and urinary disorders
Hematuria
|
6.6%
6/91 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
4.5%
4/88 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
|
Renal and urinary disorders
Renal and urinary disorders-Other
|
6.6%
6/91 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
4.5%
4/88 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
|
Vascular disorders
Hypertension
|
8.8%
8/91 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
8.0%
7/88 • Once within 14 days after preoperative treatment, once within 14 days after post-operative treatment. Death assessed for 2 years.
Adverse Events are assessed using CTCAE version 5.0. The population assessed is not the same as analysis population. The analysis population was among all randomized (not just eligible participants), with evaluability based on assessment for primary outcome. Whereas the AE/SAE population was all eligible patients, assessed for AEs, and evaluable for survival endpoints.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place