Trial Outcomes & Findings for Trial of Tremelimumab in Patients With Previously Treated Metastatic Urothelial Cancer (NCT NCT03557918)

Last Updated: 2024-07-03

Results Overview

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. ORR is defined as the proportion of all subjects with confirmed PR or CR according to RECIST 1.1.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

26 participants

Primary outcome timeframe

Up to a maximum of 12 months

Results posted on

2024-07-03

Participant Flow

Participant milestones

Participant milestones
Measure	Tremelimumab Tremelimumab 750 mg IV Day 1 of each 28 day cycle. Up to 7 cycles. Tremelimumab: Tremelimumab 750 mg IV on Day 1 of each 28 day cycle; up to 7 cycles. Subjects that complete all initial 7 cycles but later progress during follow up may receive an additional 7 cycles of tremelimumab providing they meet eligibility criteria.
Overall Study STARTED	26
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trial of Tremelimumab in Patients With Previously Treated Metastatic Urothelial Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tremelimumab n=26 Participants Tremelimumab 750 mg IV Day 1 of each 28 day cycle. Up to 7 cycles. Tremelimumab: Tremelimumab 750 mg IV on Day 1 of each 28 day cycle; up to 7 cycles. Subjects that complete all initial 7 cycles but later progress during follow up may receive an additional 7 cycles of tremelimumab providing they meet eligibility criteria.
Age, Continuous	71 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 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	1 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	5 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants
Primary Tumor Site Renal Pelvis	6 Participants n=5 Participants
Primary Tumor Site Ureter	2 Participants n=5 Participants
Primary Tumor Site Urinary Bladder	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to a maximum of 12 months

Population: Out of 26, two patients were not evaluable for response.

Outcome measures

Outcome measures
Measure	Tremelimumab n=24 Participants Tremelimumab 750 mg IV Day 1 of each 28 day cycle. Up to 7 cycles. Tremelimumab: Tremelimumab 750 mg IV on Day 1 of each 28 day cycle; up to 7 cycles. Subjects that complete all initial 7 cycles but later progress during follow up may receive an additional 7 cycles of tremelimumab providing they meet eligibility criteria.
Objective Response Rate	8.3 Percentage of participants

SECONDARY outcome

Timeframe: AE had been recorded from time of consent until 30 days after discontinuation of study drug or until a new anti-cancer treatment starts, whichever occurs first; up to a maximum of 13 months

Number of participants with adverse events are reported according to the National Cancer Institute's Common Terminology Criteria for Adverse Events(CTCAE) version 4.

Outcome measures

Outcome measures
Measure	Tremelimumab n=26 Participants Tremelimumab 750 mg IV Day 1 of each 28 day cycle. Up to 7 cycles. Tremelimumab: Tremelimumab 750 mg IV on Day 1 of each 28 day cycle; up to 7 cycles. Subjects that complete all initial 7 cycles but later progress during follow up may receive an additional 7 cycles of tremelimumab providing they meet eligibility criteria.
Adverse Events Number of patients had at least one grade 3 or greater adverse event	19 Participants
Adverse Events Number of patients had at least one grade 3 or greater treatment related adverse event	11 Participants
Adverse Events Number of patients having serious adverse event	14 Participants

SECONDARY outcome

Timeframe: Up to a maximum of 12 months

Population: Out of 26, two patients were not evaluable for response.

The disease control rate is defined as the percentage of patients who have achieved complete response, partial response and stable disease by RECIST 1.1

Outcome measures

Outcome measures
Measure	Tremelimumab n=24 Participants Tremelimumab 750 mg IV Day 1 of each 28 day cycle. Up to 7 cycles. Tremelimumab: Tremelimumab 750 mg IV on Day 1 of each 28 day cycle; up to 7 cycles. Subjects that complete all initial 7 cycles but later progress during follow up may receive an additional 7 cycles of tremelimumab providing they meet eligibility criteria.
Disease Control Rate	29.17 Percentage of participants

SECONDARY outcome

Timeframe: Up to a maximum of 24 months

Population: Out of 26, two patients were not evaluable for response.

Duration of response (DoR) is defined as the time from randomization to disease progression or death in patients who achieve complete or partial response.

Outcome measures

Outcome measures
Measure	Tremelimumab n=24 Participants Tremelimumab 750 mg IV Day 1 of each 28 day cycle. Up to 7 cycles. Tremelimumab: Tremelimumab 750 mg IV on Day 1 of each 28 day cycle; up to 7 cycles. Subjects that complete all initial 7 cycles but later progress during follow up may receive an additional 7 cycles of tremelimumab providing they meet eligibility criteria.
Duration of Response	17.45 Months Interval 10.91 to 23.98

SECONDARY outcome

Timeframe: Time of treatment start until the criteria for disease progression or death. Up to a maximum of 24 months.

Population: Out of 26 patients, only 24 patients were evaluable for PFS.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. PFS is defined as time from registration until disease progression met by RECIST 1.1 or death from any cause.

Outcome measures

Outcome measures
Measure	Tremelimumab n=24 Participants Tremelimumab 750 mg IV Day 1 of each 28 day cycle. Up to 7 cycles. Tremelimumab: Tremelimumab 750 mg IV on Day 1 of each 28 day cycle; up to 7 cycles. Subjects that complete all initial 7 cycles but later progress during follow up may receive an additional 7 cycles of tremelimumab providing they meet eligibility criteria.
Progression Free Survival (PFS)	1.83 Months Interval 1.68 to 1.91

SECONDARY outcome

Timeframe: Time of treatment start until death or date of last contact, up to a maximum of 42 months.

Overall survival is defined as the time from treatment start until death or date of last contact.

Outcome measures

Outcome measures
Measure	Tremelimumab n=26 Participants Tremelimumab 750 mg IV Day 1 of each 28 day cycle. Up to 7 cycles. Tremelimumab: Tremelimumab 750 mg IV on Day 1 of each 28 day cycle; up to 7 cycles. Subjects that complete all initial 7 cycles but later progress during follow up may receive an additional 7 cycles of tremelimumab providing they meet eligibility criteria.
Overall Survival	7.75 Months Interval 5.39 to 15.44

Adverse Events

Tremelimumab

Serious events: 14 serious events

Other events: 22 other events

Deaths: 19 deaths

Serious adverse events

Serious adverse events
Measure	Tremelimumab n=26 participants at risk Tremelimumab 750 mg IV Day 1 of each 28 day cycle. Up to 7 cycles. Tremelimumab: Tremelimumab 750 mg IV on Day 1 of each 28 day cycle; up to 7 cycles. Subjects that complete all initial 7 cycles but later progress during follow up may receive an additional 7 cycles of tremelimumab providing they meet eligibility criteria.
Investigations INVESTIGATIONS - OTHER, SPECIFY	3.8% 1/26 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Metabolism and nutrition disorders METABOLISM AND NUTRITION DISORDERS - OTHER, SPECIFY	7.7% 2/26 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
General disorders MULTI-ORGAN FAILURE	3.8% 1/26 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
General disorders PAIN	3.8% 1/26 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Respiratory, thoracic and mediastinal disorders PULMONARY EDEMA	3.8% 1/26 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Skin and subcutaneous tissue disorders RASH MACULO-PAPULAR	3.8% 1/26 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Respiratory, thoracic and mediastinal disorders RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY	3.8% 1/26 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Renal and urinary disorders ACUTE KIDNEY INJURY	11.5% 3/26 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Investigations ALANINE AMINOTRANSFERASE INCREASED	3.8% 1/26 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Musculoskeletal and connective tissue disorders BACK PAIN	3.8% 1/26 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Gastrointestinal disorders COLITIS	7.7% 2/26 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Gastrointestinal disorders COLONIC OBSTRUCTION	3.8% 1/26 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Investigations CREATININE INCREASED	7.7% 2/26 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Gastrointestinal disorders DIARRHEA	11.5% 3/26 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Nervous system disorders ENCEPHALOPATHY	3.8% 1/26 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
General disorders GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - OTHER, SPECIFY	3.8% 1/26 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Hepatobiliary disorders HEPATIC FAILURE	3.8% 1/26 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Metabolism and nutrition disorders HYPERGLYCEMIA	3.8% 1/26 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Gastrointestinal disorders ILEAL OBSTRUCTION	3.8% 1/26 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Infections and infestations SEPSIS	11.5% 3/26 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Vascular disorders THROMBOEMBOLIC EVENT	3.8% 1/26 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Infections and infestations URINARY TRACT INFECTION	3.8% 1/26 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.

Other adverse events

Other adverse events
Measure	Tremelimumab n=26 participants at risk Tremelimumab 750 mg IV Day 1 of each 28 day cycle. Up to 7 cycles. Tremelimumab: Tremelimumab 750 mg IV on Day 1 of each 28 day cycle; up to 7 cycles. Subjects that complete all initial 7 cycles but later progress during follow up may receive an additional 7 cycles of tremelimumab providing they meet eligibility criteria.
Endocrine disorders ADRENAL INSUFFICIENCY	7.7% 2/26 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Investigations ALANINE AMINOTRANSFERASE INCREASED	11.5% 3/26 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Investigations ALKALINE PHOSPHATASE INCREASED	23.1% 6/26 • Number of events 7 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Blood and lymphatic system disorders ANEMIA	30.8% 8/26 • Number of events 15 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Metabolism and nutrition disorders ANOREXIA	23.1% 6/26 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Psychiatric disorders ANXIETY	7.7% 2/26 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Musculoskeletal and connective tissue disorders ARTHRALGIA	7.7% 2/26 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	11.5% 3/26 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Musculoskeletal and connective tissue disorders BACK PAIN	11.5% 3/26 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Injury, poisoning and procedural complications BRUISING	3.8% 1/26 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
General disorders CHILLS	3.8% 1/26 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Gastrointestinal disorders COLITIS	7.7% 2/26 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Gastrointestinal disorders CONSTIPATION	7.7% 2/26 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Investigations CREATININE INCREASED	26.9% 7/26 • Number of events 16 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Psychiatric disorders DELIRIUM	3.8% 1/26 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Psychiatric disorders DEPRESSION	3.8% 1/26 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Gastrointestinal disorders DIARRHEA	42.3% 11/26 • Number of events 14 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Nervous system disorders DIZZINESS	7.7% 2/26 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Gastrointestinal disorders DRY MOUTH	7.7% 2/26 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Skin and subcutaneous tissue disorders DRY SKIN	3.8% 1/26 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Nervous system disorders DYSGEUSIA	3.8% 1/26 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Respiratory, thoracic and mediastinal disorders DYSPNEA	7.7% 2/26 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Injury, poisoning and procedural complications FALL	7.7% 2/26 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
General disorders FATIGUE	46.2% 12/26 • Number of events 14 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
General disorders FEVER	7.7% 2/26 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Gastrointestinal disorders GASTROINTESTINAL DISORDERS - OTHER, SPECIFY	7.7% 2/26 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Nervous system disorders HEADACHE	7.7% 2/26 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Renal and urinary disorders HEMATURIA	3.8% 1/26 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Respiratory, thoracic and mediastinal disorders HOARSENESS	3.8% 1/26 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Vascular disorders HOT FLASHES	3.8% 1/26 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Metabolism and nutrition disorders HYPERCALCEMIA	3.8% 1/26 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Metabolism and nutrition disorders HYPERGLYCEMIA	11.5% 3/26 • Number of events 9 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Metabolism and nutrition disorders HYPERKALEMIA	15.4% 4/26 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Vascular disorders HYPERTENSION	11.5% 3/26 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Endocrine disorders HYPERTHYROIDISM	3.8% 1/26 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Metabolism and nutrition disorders HYPOALBUMINEMIA	15.4% 4/26 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Metabolism and nutrition disorders HYPOCALCEMIA	3.8% 1/26 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Metabolism and nutrition disorders HYPOGLYCEMIA	3.8% 1/26 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Metabolism and nutrition disorders HYPOKALEMIA	7.7% 2/26 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Metabolism and nutrition disorders HYPOMAGNESEMIA	3.8% 1/26 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Metabolism and nutrition disorders HYPONATREMIA	34.6% 9/26 • Number of events 14 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Vascular disorders HYPOTENSION	3.8% 1/26 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Investigations LIPASE INCREASED	19.2% 5/26 • Number of events 10 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Investigations LYMPHOCYTE COUNT DECREASED	11.5% 3/26 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Metabolism and nutrition disorders METABOLISM AND NUTRITION DISORDERS - OTHER, SPECIFY	3.8% 1/26 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Gastrointestinal disorders MUCOSITIS ORAL	3.8% 1/26 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Musculoskeletal and connective tissue disorders MUSCLE WEAKNESS LOWER LIMB	3.8% 1/26 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER - OTHER, SPECIFY	11.5% 3/26 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Gastrointestinal disorders NAUSEA	30.8% 8/26 • Number of events 9 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Nervous system disorders NERVOUS SYSTEM DISORDERS - OTHER, SPECIFY	3.8% 1/26 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Investigations NEUTROPHIL COUNT DECREASED	3.8% 1/26 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
General disorders PAIN	3.8% 1/26 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Cardiac disorders PALPITATIONS	3.8% 1/26 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Infections and infestations PAPULOPUSTULAR RASH	7.7% 2/26 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Reproductive system and breast disorders PELVIC PAIN	3.8% 1/26 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Investigations PLATELET COUNT DECREASED	11.5% 3/26 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Renal and urinary disorders PROTEINURIA	3.8% 1/26 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Skin and subcutaneous tissue disorders PRURITUS	19.2% 5/26 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Skin and subcutaneous tissue disorders RASH ACNEIFORM	11.5% 3/26 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Skin and subcutaneous tissue disorders RASH MACULO-PAPULAR	15.4% 4/26 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Renal and urinary disorders RENAL AND URINARY DISORDERS - OTHER, SPECIFY	3.8% 1/26 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Respiratory, thoracic and mediastinal disorders RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY	3.8% 1/26 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Investigations SERUM AMYLASE INCREASED	11.5% 3/26 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Cardiac disorders SINUS TACHYCARDIA	3.8% 1/26 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Skin and subcutaneous tissue disorders SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY	3.8% 1/26 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Vascular disorders THROMBOEMBOLIC EVENT	3.8% 1/26 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Infections and infestations URINARY TRACT INFECTION	11.5% 3/26 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Skin and subcutaneous tissue disorders URTICARIA	3.8% 1/26 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Gastrointestinal disorders VOMITING	3.8% 1/26 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Investigations WEIGHT LOSS	7.7% 2/26 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.
Investigations WHITE BLOOD CELL DECREASED	7.7% 2/26 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 42 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 13 months. The Adverse Event data reported below reports each CTCAEV4 term individually per each arm/group.

Additional Information

Fauzia Sharmin

Hoosier Cancer Research Network

Phone: 317-921-2050

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place