Trial Outcomes & Findings for First-Line Gemcitabine, Cisplatin + Ipilimumab for Metastatic Urothelial Carcinoma (NCT NCT01524991)
NCT ID: NCT01524991
Last Updated: 2022-07-11
Results Overview
To determine the median overall survival of patients with advanced/metastatic urothelial cancer treated with gemcitabine, cisplatin, plus ipilimumab, calculated from the date of registration until the date of final analysis, projected to be 48 months from the start of the study.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
48 months
Results posted on
2022-07-11
Participant Flow
Participant milestones
| Measure |
Treatment
Gemcitabine 1000 mg/m2 Days 1 \& 8 Cisplatin 70 mg/m2 Day 1 Ipilimumab 10 mg/kg Day 1 (start cycle 3)
Gemcitabine: Gemcitabine 1000 mg/m2 Days 1 \& 8 (all cycles)
Cisplatin: Cisplatin 70 mg/m2 Day 1 (all cycles)
Ipilimumab: Ipilimumab 10 mg/kg Day 1 (start cycle 3)
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
34
|
Reasons for withdrawal
| Measure |
Treatment
Gemcitabine 1000 mg/m2 Days 1 \& 8 Cisplatin 70 mg/m2 Day 1 Ipilimumab 10 mg/kg Day 1 (start cycle 3)
Gemcitabine: Gemcitabine 1000 mg/m2 Days 1 \& 8 (all cycles)
Cisplatin: Cisplatin 70 mg/m2 Day 1 (all cycles)
Ipilimumab: Ipilimumab 10 mg/kg Day 1 (start cycle 3)
|
|---|---|
|
Overall Study
Adverse Event
|
12
|
|
Overall Study
Death
|
1
|
|
Overall Study
Disease ProgressionDu
|
17
|
|
Overall Study
Other complicating disease
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Symptomatic Deterioration
|
1
|
Baseline Characteristics
First-Line Gemcitabine, Cisplatin + Ipilimumab for Metastatic Urothelial Carcinoma
Baseline characteristics by cohort
| Measure |
Treatment
n=36 Participants
Gemcitabine 1000 mg/m2 Days 1 \& 8 Cisplatin 70 mg/m2 Day 1 Ipilimumab 10 mg/kg Day 1 (start cycle 3)
Gemcitabine: Gemcitabine 1000 mg/m2 Days 1 \& 8 (all cycles)
Cisplatin: Cisplatin 70 mg/m2 Day 1 (all cycles)
Ipilimumab: Ipilimumab 10 mg/kg Day 1 (start cycle 3)
|
|---|---|
|
Age, Continuous
|
36 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=93 Participants
|
|
Karnovsky Performance Status
KPS 100
|
9 Participants
n=93 Participants
|
|
Karnovsky Performance Status
KPS 90
|
16 Participants
n=93 Participants
|
|
Karnovsky Performance Status
KPS 80
|
11 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 48 monthsTo determine the median overall survival of patients with advanced/metastatic urothelial cancer treated with gemcitabine, cisplatin, plus ipilimumab, calculated from the date of registration until the date of final analysis, projected to be 48 months from the start of the study.
Outcome measures
| Measure |
Treatment
n=36 Participants
Gemcitabine 1000 mg/m2 Days 1 \& 8 Cisplatin 70 mg/m2 Day 1 Ipilimumab 10 mg/kg Day 1 (start cycle 3)
Gemcitabine: Gemcitabine 1000 mg/m2 Days 1 \& 8 (all cycles)
Cisplatin: Cisplatin 70 mg/m2 Day 1 (all cycles)
Ipilimumab: Ipilimumab 10 mg/kg Day 1 (start cycle 3)
|
|---|---|
|
Median Overall Survival
|
13.9 months
Interval 10.5 to 23.4
|
SECONDARY outcome
Timeframe: 12 monthsTo determine the progression-free survival (using irRC and RECIST v1.0) of patients with advanced/metastatic urothelial carcinoma treated with gemcitabine, cisplatin, and ipilimumab. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions". Progression is definied by IrRC as "at least 25% increase in tumor burden compared with nadir (at any single time point) in two consecutive observations at least 4 wk apart."
Outcome measures
| Measure |
Treatment
n=36 Participants
Gemcitabine 1000 mg/m2 Days 1 \& 8 Cisplatin 70 mg/m2 Day 1 Ipilimumab 10 mg/kg Day 1 (start cycle 3)
Gemcitabine: Gemcitabine 1000 mg/m2 Days 1 \& 8 (all cycles)
Cisplatin: Cisplatin 70 mg/m2 Day 1 (all cycles)
Ipilimumab: Ipilimumab 10 mg/kg Day 1 (start cycle 3)
|
|---|---|
|
Progression-Free Survival
|
7.9 months
Interval 6.4 to 9.9
|
SECONDARY outcome
Timeframe: 12 monthsTo determine the best overall response rate to treatment with gemcitabine, cisplatin, plus ipilimumab, per RECIST 1.1 criteria.
Outcome measures
| Measure |
Treatment
n=36 Participants
Gemcitabine 1000 mg/m2 Days 1 \& 8 Cisplatin 70 mg/m2 Day 1 Ipilimumab 10 mg/kg Day 1 (start cycle 3)
Gemcitabine: Gemcitabine 1000 mg/m2 Days 1 \& 8 (all cycles)
Cisplatin: Cisplatin 70 mg/m2 Day 1 (all cycles)
Ipilimumab: Ipilimumab 10 mg/kg Day 1 (start cycle 3)
|
|---|---|
|
Best Overall Response Rate
Complete Response (CR)
|
6 Participants
|
|
Best Overall Response Rate
Partial Response (PR)
|
19 Participants
|
|
Best Overall Response Rate
Stable Disease (SD)
|
10 Participants
|
|
Best Overall Response Rate
Progressive Disease (PD)
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 monthsTo determine the safety of treatment with gemcitabine, cisplatin, plus ipilimumab. The highest grade adverse event for each subject is presented.
Outcome measures
| Measure |
Treatment
n=36 Participants
Gemcitabine 1000 mg/m2 Days 1 \& 8 Cisplatin 70 mg/m2 Day 1 Ipilimumab 10 mg/kg Day 1 (start cycle 3)
Gemcitabine: Gemcitabine 1000 mg/m2 Days 1 \& 8 (all cycles)
Cisplatin: Cisplatin 70 mg/m2 Day 1 (all cycles)
Ipilimumab: Ipilimumab 10 mg/kg Day 1 (start cycle 3)
|
|---|---|
|
Number of Adverse Events Experienced by Patients
Grade 1
|
1 Participants
|
|
Number of Adverse Events Experienced by Patients
Grade 2
|
6 Participants
|
|
Number of Adverse Events Experienced by Patients
Grade 3
|
19 Participants
|
|
Number of Adverse Events Experienced by Patients
Grade 4
|
10 Participants
|
Adverse Events
Treatment
Serious events: 18 serious events
Other events: 36 other events
Deaths: 28 deaths
Serious adverse events
| Measure |
Treatment
n=36 participants at risk
Gemcitabine 1000 mg/m2 Days 1 \& 8 Cisplatin 70 mg/m2 Day 1 Ipilimumab 10 mg/kg Day 1 (start cycle 3)
Gemcitabine: Gemcitabine 1000 mg/m2 Days 1 \& 8 (all cycles)
Cisplatin: Cisplatin 70 mg/m2 Day 1 (all cycles)
Ipilimumab: Ipilimumab 10 mg/kg Day 1 (start cycle 3)
|
|---|---|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
8.3%
3/36 • Number of events 3 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Endocrine disorders
ADRENAL INSUFFICIENCY
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Blood and lymphatic system disorders
ANEMIA
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
5.6%
2/36 • Number of events 2 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Immune system disorders
AUTOIMMUNE DISORDER
|
5.6%
2/36 • Number of events 3 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Gastrointestinal disorders
COLITIS
|
2.8%
1/36 • Number of events 2 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Investigations
CREATININE INCREASED
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Gastrointestinal disorders
DIARRHEA
|
5.6%
2/36 • Number of events 3 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Endocrine disorders
ENDOCRINE DISORDERS - OTHER, SPECIFY
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
General disorders
FEVER
|
11.1%
4/36 • Number of events 5 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Endocrine disorders
HYPERTHYROIDISM
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
2.8%
1/36 • Number of events 2 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Infections and infestations
LUNG INFECTION
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Gastrointestinal disorders
OBSTRUCTION GASTRIC
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Nervous system disorders
PERIPHERAL MOTOR NEUROPATHY
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Gastrointestinal disorders
RECTAL PAIN
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Infections and infestations
SEPSIS
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
2.8%
1/36 • Number of events 2 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Vascular disorders
THROMBOEMBOLIC EVENT
|
13.9%
5/36 • Number of events 9 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HEMORRHAGE
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Infections and infestations
UPPER RESPIRATORY INFECTION
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Infections and infestations
URINARY TRACT INFECTION
|
8.3%
3/36 • Number of events 3 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
Other adverse events
| Measure |
Treatment
n=36 participants at risk
Gemcitabine 1000 mg/m2 Days 1 \& 8 Cisplatin 70 mg/m2 Day 1 Ipilimumab 10 mg/kg Day 1 (start cycle 3)
Gemcitabine: Gemcitabine 1000 mg/m2 Days 1 \& 8 (all cycles)
Cisplatin: Cisplatin 70 mg/m2 Day 1 (all cycles)
Ipilimumab: Ipilimumab 10 mg/kg Day 1 (start cycle 3)
|
|---|---|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
38.9%
14/36 • Number of events 19 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Endocrine disorders
ADRENAL INSUFFICIENCY
|
5.6%
2/36 • Number of events 2 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Psychiatric disorders
AGITATION
|
5.6%
2/36 • Number of events 2 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
13.9%
5/36 • Number of events 7 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Investigations
ALKALINE PHOSPHATASE INCREASED
|
13.9%
5/36 • Number of events 10 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Immune system disorders
ALLERGIC REACTION
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
ALLERGIC RHINITIS
|
11.1%
4/36 • Number of events 4 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
27.8%
10/36 • Number of events 12 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Blood and lymphatic system disorders
ANEMIA
|
66.7%
24/36 • Number of events 109 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Metabolism and nutrition disorders
ANOREXIA
|
52.8%
19/36 • Number of events 30 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Psychiatric disorders
ANXIETY
|
19.4%
7/36 • Number of events 7 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
11.1%
4/36 • Number of events 4 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Gastrointestinal disorders
ASCITES
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
11.1%
4/36 • Number of events 7 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
8.3%
3/36 • Number of events 4 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
30.6%
11/36 • Number of events 17 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Renal and urinary disorders
BLADDER SPASM
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Gastrointestinal disorders
BLOATING
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Eye disorders
BLURRED VISION
|
11.1%
4/36 • Number of events 4 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
11.1%
4/36 • Number of events 4 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Injury, poisoning and procedural complications
BRUISING
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Eye disorders
CATARACT
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Cardiac disorders
CHEST PAIN - CARDIAC
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Musculoskeletal and connective tissue disorders
CHEST WALL PAIN
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
General disorders
CHILLS
|
19.4%
7/36 • Number of events 9 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Investigations
CHOLESTEROL HIGH
|
11.1%
4/36 • Number of events 4 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Gastrointestinal disorders
COLITIS
|
11.1%
4/36 • Number of events 4 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Gastrointestinal disorders
CONSTIPATION
|
66.7%
24/36 • Number of events 34 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
50.0%
18/36 • Number of events 24 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Investigations
CREATININE INCREASED
|
33.3%
12/36 • Number of events 26 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
19.4%
7/36 • Number of events 11 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Psychiatric disorders
DELIRIUM
|
5.6%
2/36 • Number of events 2 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Psychiatric disorders
DEPRESSION
|
16.7%
6/36 • Number of events 6 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Gastrointestinal disorders
DIARRHEA
|
63.9%
23/36 • Number of events 40 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Nervous system disorders
DIZZINESS
|
30.6%
11/36 • Number of events 14 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
11.1%
4/36 • Number of events 4 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Nervous system disorders
DYSGEUSIA
|
30.6%
11/36 • Number of events 13 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Gastrointestinal disorders
DYSPEPSIA
|
25.0%
9/36 • Number of events 11 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Gastrointestinal disorders
DYSPHAGIA
|
2.8%
1/36 • Number of events 2 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
44.4%
16/36 • Number of events 18 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Ear and labyrinth disorders
EAR PAIN
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
General disorders
EDEMA LIMBS
|
30.6%
11/36 • Number of events 15 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Nervous system disorders
ENCEPHALOPATHY
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Endocrine disorders
ENDOCRINE DISORDERS - OTHER, SPECIFY
|
11.1%
4/36 • Number of events 5 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
5.6%
2/36 • Number of events 4 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Reproductive system and breast disorders
ERECTILE DYSFUNCTION
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA MULTIFORME
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Injury, poisoning and procedural complications
FALL
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
General disorders
FATIGUE
|
91.7%
33/36 • Number of events 71 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
General disorders
FEVER
|
33.3%
12/36 • Number of events 17 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
16.7%
6/36 • Number of events 8 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
General disorders
FLU LIKE SYMPTOMS
|
5.6%
2/36 • Number of events 2 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
General disorders
GAIT DISTURBANCE
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Gastrointestinal disorders
GASTROESOPHAGEAL REFLUX DISEASE
|
13.9%
5/36 • Number of events 5 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Gastrointestinal disorders
GASTROINTESTINAL DISORDERS - OTHER, SPECIFY
|
5.6%
2/36 • Number of events 2 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Gastrointestinal disorders
GASTROINTESTINAL PAIN
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
General disorders
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - OTHER, SPECIFY
|
5.6%
2/36 • Number of events 2 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Musculoskeletal and connective tissue disorders
GENERALIZED MUSCLE WEAKNESS
|
11.1%
4/36 • Number of events 5 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Reproductive system and breast disorders
GENITAL EDEMA
|
5.6%
2/36 • Number of events 2 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Nervous system disorders
HEADACHE
|
33.3%
12/36 • Number of events 17 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Ear and labyrinth disorders
HEARING IMPAIRED
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Renal and urinary disorders
HEMATURIA
|
27.8%
10/36 • Number of events 11 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
HICCUPS
|
13.9%
5/36 • Number of events 5 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
HOARSENESS
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Vascular disorders
HOT FLASHES
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Metabolism and nutrition disorders
HYPERCALCEMIA
|
2.8%
1/36 • Number of events 2 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
16.7%
6/36 • Number of events 9 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Metabolism and nutrition disorders
HYPERKALEMIA
|
11.1%
4/36 • Number of events 9 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Vascular disorders
HYPERTENSION
|
27.8%
10/36 • Number of events 11 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Endocrine disorders
HYPERTHYROIDISM
|
5.6%
2/36 • Number of events 2 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDEMIA
|
5.6%
2/36 • Number of events 2 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Metabolism and nutrition disorders
HYPERURICEMIA
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Metabolism and nutrition disorders
HYPOALBUMINEMIA
|
13.9%
5/36 • Number of events 18 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
8.3%
3/36 • Number of events 3 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Metabolism and nutrition disorders
HYPOGLYCEMIA
|
2.8%
1/36 • Number of events 2 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
25.0%
9/36 • Number of events 19 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Metabolism and nutrition disorders
HYPOMAGNESEMIA
|
25.0%
9/36 • Number of events 26 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
47.2%
17/36 • Number of events 41 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATEMIA
|
8.3%
3/36 • Number of events 3 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Vascular disorders
HYPOTENSION
|
5.6%
2/36 • Number of events 3 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Endocrine disorders
HYPOTHYROIDISM
|
11.1%
4/36 • Number of events 5 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
5.6%
2/36 • Number of events 2 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Infections and infestations
INFECTIONS AND INFESTATIONS - OTHER, SPECIFY
|
11.1%
4/36 • Number of events 5 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Injury, poisoning and procedural complications
INJURY, POISONING AND PROCEDURAL COMPLICATIONS - OTHER, SPECIFY
|
2.8%
1/36 • Number of events 3 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Psychiatric disorders
INSOMNIA
|
30.6%
11/36 • Number of events 12 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Investigations
INVESTIGATIONS - OTHER, SPECIFY
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Infections and infestations
KIDNEY INFECTION
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Infections and infestations
LIP INFECTION
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
General disorders
LOCALIZED EDEMA
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Vascular disorders
LYMPHEDEMA
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
13.9%
5/36 • Number of events 13 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
General disorders
MALAISE
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Metabolism and nutrition disorders
METABOLISM AND NUTRITION DISORDERS - OTHER, SPECIFY
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Gastrointestinal disorders
MUCOSITIS ORAL
|
11.1%
4/36 • Number of events 6 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS UPPER LIMB
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
8.3%
3/36 • Number of events 3 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Gastrointestinal disorders
NAUSEA
|
75.0%
27/36 • Number of events 64 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Nervous system disorders
NERVOUS SYSTEM DISORDERS - OTHER, SPECIFY
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Nervous system disorders
NEURALGIA
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
58.3%
21/36 • Number of events 56 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
5.6%
2/36 • Number of events 2 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Metabolism and nutrition disorders
OBESITY
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Gastrointestinal disorders
OBSTRUCTION GASTRIC
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Gastrointestinal disorders
ORAL PAIN
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
General disorders
PAIN
|
41.7%
15/36 • Number of events 22 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
27.8%
10/36 • Number of events 15 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Skin and subcutaneous tissue disorders
PAIN OF SKIN
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Cardiac disorders
PALPITATIONS
|
5.6%
2/36 • Number of events 2 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Infections and infestations
PAPULOPUSTULAR RASH
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Nervous system disorders
PARESTHESIA
|
5.6%
2/36 • Number of events 2 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Reproductive system and breast disorders
PELVIC PAIN
|
8.3%
3/36 • Number of events 3 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Nervous system disorders
PERIPHERAL MOTOR NEUROPATHY
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
44.4%
16/36 • Number of events 20 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Vascular disorders
PHLEBITIS
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Investigations
PLATELET COUNT DECREASED
|
47.2%
17/36 • Number of events 38 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
5.6%
2/36 • Number of events 2 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
2.8%
1/36 • Number of events 2 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Reproductive system and breast disorders
PROSTATIC OBSTRUCTION
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Renal and urinary disorders
PROTEINURIA
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
19.4%
7/36 • Number of events 9 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EDEMA
|
5.6%
2/36 • Number of events 2 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY FIBROSIS
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Skin and subcutaneous tissue disorders
PURPURA
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Skin and subcutaneous tissue disorders
RASH ACNEIFORM
|
19.4%
7/36 • Number of events 9 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
19.4%
7/36 • Number of events 13 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Infections and infestations
RASH PUSTULAR
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Gastrointestinal disorders
RECTAL HEMORRHAGE
|
5.6%
2/36 • Number of events 2 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Gastrointestinal disorders
RECTAL PAIN
|
2.8%
1/36 • Number of events 2 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Renal and urinary disorders
RENAL AND URINARY DISORDERS - OTHER, SPECIFY
|
19.4%
7/36 • Number of events 9 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Renal and urinary disorders
RENAL CALCULI
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Psychiatric disorders
RESTLESSNESS
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Cardiac disorders
SINUS BRADYCARDIA
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
SINUS DISORDER
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Skin and subcutaneous tissue disorders
SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY
|
16.7%
6/36 • Number of events 6 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Infections and infestations
SKIN INFECTION
|
13.9%
5/36 • Number of events 7 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Skin and subcutaneous tissue disorders
SKIN ULCERATION
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Infections and infestations
SMALL INTESTINE INFECTION
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
SNEEZING
|
5.6%
2/36 • Number of events 3 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Nervous system disorders
SOMNOLENCE
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
SORE THROAT
|
8.3%
3/36 • Number of events 6 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Vascular disorders
SUPERFICIAL THROMBOPHLEBITIS
|
5.6%
2/36 • Number of events 2 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Surgical and medical procedures
SURGICAL AND MEDICAL PROCEDURES - OTHER, SPECIFY
|
5.6%
2/36 • Number of events 2 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Nervous system disorders
SYNCOPE
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Vascular disorders
THROMBOEMBOLIC EVENT
|
16.7%
6/36 • Number of events 7 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Ear and labyrinth disorders
TINNITUS
|
11.1%
4/36 • Number of events 7 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Nervous system disorders
TREMOR
|
8.3%
3/36 • Number of events 3 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Infections and infestations
UPPER RESPIRATORY INFECTION
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Renal and urinary disorders
URINARY FREQUENCY
|
16.7%
6/36 • Number of events 7 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
5.6%
2/36 • Number of events 2 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Renal and urinary disorders
URINARY RETENTION
|
5.6%
2/36 • Number of events 2 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Infections and infestations
URINARY TRACT INFECTION
|
30.6%
11/36 • Number of events 14 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Renal and urinary disorders
URINARY TRACT PAIN
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Renal and urinary disorders
URINARY URGENCY
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Vascular disorders
VASCULAR DISORDERS - OTHER, SPECIFY
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Gastrointestinal disorders
VOMITING
|
38.9%
14/36 • Number of events 35 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Investigations
WEIGHT GAIN
|
5.6%
2/36 • Number of events 9 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Investigations
WEIGHT LOSS
|
19.4%
7/36 • Number of events 12 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Investigations
WHITE BLOOD CELL DECREASED
|
19.4%
7/36 • Number of events 18 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
|
Infections and infestations
WOUND INFECTION
|
2.8%
1/36 • Number of events 1 • From the start of treatment to 30 days following the last treatment, a maximum of 1 year
|
Additional Information
Clinicaltrials.gov Results Coordinator
Hoosier Cancer Research Network
Phone: 317-643-5842
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place