Trial Outcomes & Findings for Cisplatin, Gemcitabine and Bevacizumab in Combination for Metastatic Transitional Cell Cancer (NCT NCT00234494)
NCT ID: NCT00234494
Last Updated: 2016-03-14
Results Overview
\- To determine the progression free survival of patients with metastatic transitional cell cancer treated with cisplatin, gemcitabine and bevacizumab.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
36 months
Results posted on
2016-03-14
Participant Flow
Participant milestones
| Measure |
Single Group Assignment
Cisplatin + Gemcitabine + Bevacizumab
Cisplatin: Cisplatin 70 mg/m2, day 1
Gemcitabine: Gemcitabine 1250 mg/m2, day 1 and 8
Bevacizumab: Bevacizumab 15mg/kg, day 1
|
|---|---|
|
Overall Study
STARTED
|
45
|
|
Overall Study
COMPLETED
|
43
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Single Group Assignment
Cisplatin + Gemcitabine + Bevacizumab
Cisplatin: Cisplatin 70 mg/m2, day 1
Gemcitabine: Gemcitabine 1250 mg/m2, day 1 and 8
Bevacizumab: Bevacizumab 15mg/kg, day 1
|
|---|---|
|
Overall Study
Protocol Violation
|
2
|
Baseline Characteristics
Cisplatin, Gemcitabine and Bevacizumab in Combination for Metastatic Transitional Cell Cancer
Baseline characteristics by cohort
| Measure |
Single Group Assignment
n=43 Participants
Cisplatin + Gemcitabine + Bevacizumab
Cisplatin: Cisplatin 70 mg/m2, day 1
Gemcitabine: Gemcitabine 1250 mg/m2, day 1 and 8
Bevacizumab: Bevacizumab 15mg/kg, day 1
|
|---|---|
|
Age, Customized
Age
|
66 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=93 Participants
|
|
Body Mass Index, kg/m2
|
27.7 kg/m2
n=93 Participants
|
|
Creatinine, mg/dL
|
1.1 mg/dL
n=93 Participants
|
|
WBC Count
|
7600 K/ul
n=93 Participants
|
|
Hemoglobin
|
13.0 g/dL
n=93 Participants
|
|
Platelet count
|
291000 platelets per ul
n=93 Participants
|
|
Number of metastatic sites
|
2 number of metastatic sites
n=93 Participants
|
|
Prior cystectomy
Yes
|
17 participants
n=93 Participants
|
|
Prior cystectomy
No
|
26 participants
n=93 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG 0
|
26 participants
n=93 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG 1
|
17 participants
n=93 Participants
|
|
Metastatic Site Locations
Any lymph node
|
39 number of metastatic sites per location
n=93 Participants
|
|
Metastatic Site Locations
Pelvic/abdominal lymph node
|
27 number of metastatic sites per location
n=93 Participants
|
|
Metastatic Site Locations
Any visceral metastases
|
30 number of metastatic sites per location
n=93 Participants
|
|
Metastatic Site Locations
Lung
|
18 number of metastatic sites per location
n=93 Participants
|
|
Metastatic Site Locations
Bone
|
11 number of metastatic sites per location
n=93 Participants
|
|
Modified Bajorin risk group
Good risk
|
8 participants
n=93 Participants
|
|
Modified Bajorin risk group
Intermediate risk
|
23 participants
n=93 Participants
|
|
Modified Bajorin risk group
Poor risk
|
12 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 36 months\- To determine the progression free survival of patients with metastatic transitional cell cancer treated with cisplatin, gemcitabine and bevacizumab.
Outcome measures
| Measure |
Single Group Assignment
n=43 Participants
Cisplatin + Gemcitabine + Bevacizumab
Cisplatin: Cisplatin 70 mg/m2, day 1
Gemcitabine: Gemcitabine 1250 mg/m2, day 1 and 8
Bevacizumab: Bevacizumab 15mg/kg, day 1
|
|---|---|
|
Progression Free Survival
|
8.2 months
Interval 6.8 to 10.3
|
SECONDARY outcome
Timeframe: 36 monthsTo estimate overall survival time in months.
Outcome measures
| Measure |
Single Group Assignment
n=43 Participants
Cisplatin + Gemcitabine + Bevacizumab
Cisplatin: Cisplatin 70 mg/m2, day 1
Gemcitabine: Gemcitabine 1250 mg/m2, day 1 and 8
Bevacizumab: Bevacizumab 15mg/kg, day 1
|
|---|---|
|
Overall Survival Time
|
19.1 months
Interval 12.4 to 22.7
|
SECONDARY outcome
Timeframe: 36 monthsTo estimate rate of partial response (PR), complete response (CR) and overall response (PR plus CR).
Outcome measures
| Measure |
Single Group Assignment
n=43 Participants
Cisplatin + Gemcitabine + Bevacizumab
Cisplatin: Cisplatin 70 mg/m2, day 1
Gemcitabine: Gemcitabine 1250 mg/m2, day 1 and 8
Bevacizumab: Bevacizumab 15mg/kg, day 1
|
|---|---|
|
Estimate Response Rates
complete reponse
|
19 percentage of participants
|
|
Estimate Response Rates
partial reponse
|
53 percentage of participants
|
|
Estimate Response Rates
overall response
|
72 percentage of participants
|
SECONDARY outcome
Timeframe: 36 monthsPopulation: Data for this secondary outcome measure was not collected or analyzed.
To estimate duration of response for responding patients.
Outcome measures
Outcome data not reported
Adverse Events
Single Group Assignment
Serious events: 26 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single Group Assignment
n=45 participants at risk
Cisplatin + Gemcitabine + Bevacizumab
Cisplatin: Cisplatin 70 mg/m2, day 1
Gemcitabine: Gemcitabine 1250 mg/m2, day 1 and 8
Bevacizumab: Bevacizumab 15mg/kg, day 1
|
|---|---|
|
Cardiac disorders
CARDIAC GENERAL - OTHER (SPECIFY, __)
|
4.4%
2/45 • Number of events 2
|
|
Nervous system disorders
CONFUSION
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
CONSTIPATION
|
4.4%
2/45 • Number of events 2
|
|
Gastrointestinal disorders
DEHYDRATION
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
FEBRILE NEUTROPENIA (ANC <1.0 X 10E9/L, FEVER >=38.5 DEGREES C)
|
2.2%
1/45 • Number of events 1
|
|
General disorders
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
|
2.2%
1/45 • Number of events 3
|
|
Blood and lymphatic system disorders
HEMOGLOBIN
|
2.2%
1/45 • Number of events 1
|
|
Nervous system disorders
HEMORRHAGE, CNS
|
4.4%
2/45 • Number of events 2
|
|
Gastrointestinal disorders
HEMORRHAGE, GI / ABDOMEN NOS
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / URINARY TRACT NOS
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / CATHETER-RELATED
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / SCROTUM
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / URINARY TRACT NOS
|
6.7%
3/45 • Number of events 3
|
|
Eye disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / EXTRAOCULAR
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
NAUSEA
|
2.2%
1/45 • Number of events 1
|
|
Renal and urinary disorders
OBSTRUCTION, GU / URETER
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
PAIN / ABDOMEN NOS
|
2.2%
1/45 • Number of events 1
|
|
General disorders
PAIN / BACK
|
2.2%
1/45 • Number of events 1
|
|
Vascular disorders
PHLEBITIS (INCLUDING SUPERFICIAL THROMBOSIS)
|
2.2%
1/45 • Number of events 1
|
|
Blood and lymphatic system disorders
PLATELETS
|
2.2%
1/45 • Number of events 1
|
|
Investigations
PROTEINURIA
|
2.2%
1/45 • Number of events 1
|
|
Renal and urinary disorders
RENAL FAILURE
|
4.4%
2/45 • Number of events 2
|
|
Nervous system disorders
SEIZURE
|
2.2%
1/45 • Number of events 1
|
|
Cardiac disorders
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / SINUS BRADYCARDIA
|
2.2%
1/45 • Number of events 1
|
|
Vascular disorders
THROMBOSIS/THROMBUS/EMBOLISM
|
11.1%
5/45 • Number of events 6
|
|
Vascular disorders
VESSEL INJURY-ARTERY / AORTA
|
2.2%
1/45 • Number of events 1
|
Other adverse events
| Measure |
Single Group Assignment
n=45 participants at risk
Cisplatin + Gemcitabine + Bevacizumab
Cisplatin: Cisplatin 70 mg/m2, day 1
Gemcitabine: Gemcitabine 1250 mg/m2, day 1 and 8
Bevacizumab: Bevacizumab 15mg/kg, day 1
|
|---|---|
|
Gastrointestinal disorders
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) / ORAL CAVITY
|
8.9%
4/45 • Number of events 5
|
|
Eye disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / EXTRAOCULAR
|
2.2%
1/45 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / EXTREMITY-UPPER
|
2.2%
1/45 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / WHOLE BODY/GENERALIZED
|
8.9%
4/45 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL/SOFT TISSUE - OTHER (SPECIFY, __)
|
2.2%
1/45 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CAVITY/PARANASAL SINUS REACTIONS
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
NAUSEA
|
68.9%
31/45 • Number of events 67
|
|
Nervous system disorders
NEUROLOGY - OTHER (SPECIFY, __)
|
6.7%
3/45 • Number of events 3
|
|
Nervous system disorders
NEUROPATHY: MOTOR
|
4.4%
2/45 • Number of events 3
|
|
Nervous system disorders
NEUROPATHY: SENSORY
|
33.3%
15/45 • Number of events 16
|
|
Blood and lymphatic system disorders
NEUTROPHILS/GRANULOCYTES (ANC/AGC)
|
48.9%
22/45 • Number of events 36
|
|
Eye disorders
OCULAR/VISUAL - OTHER (SPECIFY, __)
|
2.2%
1/45 • Number of events 1
|
|
Eye disorders
OPHTHALMOPLEGIA/DIPLOPIA (DOUBLE VISION)
|
2.2%
1/45 • Number of events 4
|
|
Gastrointestinal disorders
PAIN / ABDOMEN NOS
|
17.8%
8/45 • Number of events 10
|
|
Gastrointestinal disorders
PAIN / ANUS
|
2.2%
1/45 • Number of events 1
|
|
General disorders
PAIN / BACK
|
26.7%
12/45 • Number of events 18
|
|
Renal and urinary disorders
PAIN / BLADDER
|
4.4%
2/45 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
PAIN / BONE
|
6.7%
3/45 • Number of events 3
|
|
Nervous system disorders
CONFUSION
|
4.4%
2/45 • Number of events 2
|
|
Gastrointestinal disorders
CONSTIPATION
|
55.6%
25/45 • Number of events 32
|
|
General disorders
CONSTITUTIONAL SYMPTOMS - OTHER (SPECIFY, __)
|
2.2%
1/45 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
22.2%
10/45 • Number of events 15
|
|
Investigations
CREATININE
|
26.7%
12/45 • Number of events 17
|
|
Gastrointestinal disorders
DEHYDRATION
|
4.4%
2/45 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN - OTHER (SPECIFY, __)
|
6.7%
3/45 • Number of events 3
|
|
Gastrointestinal disorders
DIARRHEA
|
28.9%
13/45 • Number of events 17
|
|
Gastrointestinal disorders
DISTENSION/BLOATING, ABDOMINAL
|
2.2%
1/45 • Number of events 1
|
|
Nervous system disorders
DIZZINESS
|
8.9%
4/45 • Number of events 4
|
|
Gastrointestinal disorders
DRY MOUTH/SALIVARY GLAND (XEROSTOMIA)
|
2.2%
1/45 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)
|
26.7%
12/45 • Number of events 20
|
|
Blood and lymphatic system disorders
EDEMA: LIMB
|
8.9%
4/45 • Number of events 8
|
|
General disorders
FATIGUE (ASTHENIA, LETHARGY, MALAISE)
|
77.8%
35/45 • Number of events 64
|
|
General disorders
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
|
20.0%
9/45 • Number of events 13
|
|
Respiratory, thoracic and mediastinal disorders
FISTULA, PULMONARY/UPPER RESPIRATORY / LUNG
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
GASTRITIS (INCLUDING BILE REFLUX GASTRITIS)
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
GASTROINTESTINAL - OTHER (SPECIFY, __)
|
6.7%
3/45 • Number of events 3
|
|
Investigations
GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)
|
8.9%
4/45 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
HAIR LOSS/ALOPECIA (SCALP OR BODY)
|
31.1%
14/45 • Number of events 14
|
|
Ear and labyrinth disorders
HEARING: PATIENTS WITHOUT BASELINE AUDIOGRAM AND NOT ENROLLED IN A MONITORING PROGRAM
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
HEARTBURN/DYSPEPSIA
|
17.8%
8/45 • Number of events 10
|
|
Blood and lymphatic system disorders
HEMOGLOBIN
|
44.4%
20/45 • Number of events 43
|
|
Gastrointestinal disorders
HEMORRHAGE, GU / BLADDER
|
6.7%
3/45 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY / NOSE
|
17.8%
8/45 • Number of events 10
|
|
General disorders
HEMORRHAGE/BLEEDING - OTHER (SPECIFY, __)
|
6.7%
3/45 • Number of events 3
|
|
Injury, poisoning and procedural complications
HEMORRHAGE/BLEEDING ASSOCIATED WITH SURGERY, INTRA-OPERATIVE OR POSTOPERATIVE
|
2.2%
1/45 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
HICCOUGHS (HICCUPS, SINGULTUS)
|
13.3%
6/45 • Number of events 6
|
|
Endocrine disorders
HOT FLASHES/FLUSHES
|
2.2%
1/45 • Number of events 1
|
|
Cardiac disorders
HYPERTENSION
|
31.1%
14/45 • Number of events 19
|
|
Cardiac disorders
HYPOTENSION
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / DENTAL-TOOTH
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / URINARY TRACT NOS
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
INFECTION - OTHER (SPECIFY, __)
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / ABDOMEN NOS
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / BLADDER (URINARY)
|
4.4%
2/45 • Number of events 3
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / BRONCHUS
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / COLON
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / CONJUNCTIVA
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / EYE NOS
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / RECTUM
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / SINUS
|
11.1%
5/45 • Number of events 6
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / SKIN (CELLULITIS)
|
4.4%
2/45 • Number of events 2
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / URINARY TRACT NOS
|
8.9%
4/45 • Number of events 4
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC / SINUS
|
2.2%
1/45 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
INJECTION SITE REACTION/EXTRAVASATION CHANGES
|
2.2%
1/45 • Number of events 1
|
|
General disorders
INSOMNIA
|
31.1%
14/45 • Number of events 20
|
|
Cardiac disorders
LEFT VENTRICULAR SYSTOLIC DYSFUNCTION
|
4.4%
2/45 • Number of events 2
|
|
Blood and lymphatic system disorders
LEUKOCYTES (TOTAL WBC)
|
17.8%
8/45 • Number of events 15
|
|
Investigations
MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA)
|
6.7%
3/45 • Number of events 3
|
|
Investigations
METABOLIC/LABORATORY - OTHER (SPECIFY, __)
|
15.6%
7/45 • Number of events 10
|
|
Psychiatric disorders
MOOD ALTERATION / AGITATION
|
2.2%
1/45 • Number of events 2
|
|
Psychiatric disorders
MOOD ALTERATION / ANXIETY
|
17.8%
8/45 • Number of events 10
|
|
Psychiatric disorders
MOOD ALTERATION / DEPRESSION
|
13.3%
6/45 • Number of events 10
|
|
Investigations
ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)
|
2.2%
1/45 • Number of events 1
|
|
Investigations
ALKALINE PHOSPHATASE
|
2.2%
1/45 • Number of events 1
|
|
Immune system disorders
ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP)
|
4.4%
2/45 • Number of events 6
|
|
Investigations
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
ANOREXIA
|
57.8%
26/45 • Number of events 38
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS (NON-SEPTIC)
|
4.4%
2/45 • Number of events 2
|
|
Investigations
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
|
2.2%
1/45 • Number of events 1
|
|
Ear and labyrinth disorders
AUDITORY/EAR - OTHER (SPECIFY, __)
|
2.2%
1/45 • Number of events 1
|
|
Blood and lymphatic system disorders
BLOOD/BONE MARROW - OTHER (SPECIFY, __)
|
4.4%
2/45 • Number of events 3
|
|
Investigations
CALCIUM, SERUM-HIGH (HYPERCALCEMIA)
|
4.4%
2/45 • Number of events 2
|
|
Investigations
CALCIUM, SERUM-LOW (HYPOCALCEMIA)
|
2.2%
1/45 • Number of events 2
|
|
Cardiac disorders
CARDIAC GENERAL - OTHER (SPECIFY, __)
|
2.2%
1/45 • Number of events 1
|
|
Eye disorders
CATARACT
|
2.2%
1/45 • Number of events 1
|
|
Investigations
CHOLESTEROL, SERUM-HIGH (HYPERCHOLESTREMIA)
|
2.2%
1/45 • Number of events 1
|
|
Surgical and medical procedures
MUCOSITIS/STOMATITIS (CLINICAL EXAM) / ORAL CAVITY
|
20.0%
9/45 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
PAIN / CHEST/THORAX NOS
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
PAIN / DENTAL/TEETH/PERIDONTAL
|
4.4%
2/45 • Number of events 3
|
|
Ear and labyrinth disorders
PAIN / EXTERNAL EAR
|
2.2%
1/45 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
PAIN / EXTREMITY-LIMB
|
13.3%
6/45 • Number of events 7
|
|
General disorders
PAIN / HEAD/HEADACHE
|
22.2%
10/45 • Number of events 14
|
|
Musculoskeletal and connective tissue disorders
PAIN / JOINT
|
13.3%
6/45 • Number of events 8
|
|
Renal and urinary disorders
PAIN / KIDNEY
|
2.2%
1/45 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
PAIN / MUSCLE
|
4.4%
2/45 • Number of events 2
|
|
General disorders
PAIN / PAIN NOS
|
2.2%
1/45 • Number of events 1
|
|
General disorders
PAIN / PELVIS
|
4.4%
2/45 • Number of events 2
|
|
Reproductive system and breast disorders
PAIN / PENIS
|
2.2%
1/45 • Number of events 2
|
|
General disorders
PAIN / PERINEUM
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
PAIN / RECTUM
|
2.2%
1/45 • Number of events 2
|
|
Gastrointestinal disorders
PAIN / STOMACH
|
4.4%
2/45 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
PAIN / THROAT/PHARYNX/LARYNX
|
2.2%
1/45 • Number of events 1
|
|
Renal and urinary disorders
PAIN / URETHRA
|
2.2%
1/45 • Number of events 1
|
|
Reproductive system and breast disorders
PAIN / VAGINA
|
2.2%
1/45 • Number of events 4
|
|
General disorders
PAIN - OTHER (SPECIFY, __)
|
22.2%
10/45 • Number of events 15
|
|
Endocrine disorders
PANCREATIC ENDOCRINE: GLUCOSE INTOLERANCE
|
4.4%
2/45 • Number of events 2
|
|
Vascular disorders
PHLEBITIS (INCLUDING SUPERFICIAL THROMBOSIS)
|
4.4%
2/45 • Number of events 2
|
|
Blood and lymphatic system disorders
PLATELETS
|
22.2%
10/45 • Number of events 21
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS/PULMONARY INFILTRATES
|
2.2%
1/45 • Number of events 1
|
|
Investigations
POTASSIUM, SERUM-HIGH (HYPERKALEMIA)
|
2.2%
1/45 • Number of events 1
|
|
Investigations
POTASSIUM, SERUM-LOW (HYPOKALEMIA)
|
4.4%
2/45 • Number of events 4
|
|
Investigations
PROTEINURIA
|
13.3%
6/45 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
PRURITUS/ITCHING
|
11.1%
5/45 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY/UPPER RESPIRATORY - OTHER (SPECIFY, __)
|
4.4%
2/45 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
RASH/DESQUAMATION
|
4.4%
2/45 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
RASH: ACNE/ACNEIFORM
|
8.9%
4/45 • Number of events 5
|
|
Renal and urinary disorders
RENAL/GENITOURINARY - OTHER (SPECIFY, __)
|
11.1%
5/45 • Number of events 5
|
|
General disorders
RIGORS/CHILLS
|
4.4%
2/45 • Number of events 5
|
|
Investigations
SODIUM, SERUM-LOW (HYPONATREMIA)
|
2.2%
1/45 • Number of events 2
|
|
General disorders
SWEATING (DIAPHORESIS)
|
8.9%
4/45 • Number of events 4
|
|
Gastrointestinal disorders
TASTE ALTERATION (DYSGEUSIA)
|
22.2%
10/45 • Number of events 14
|
|
Vascular disorders
THROMBOSIS/THROMBUS/EMBOLISM
|
8.9%
4/45 • Number of events 5
|
|
Endocrine disorders
THYROID FUNCTION, LOW (HYPOTHYROIDISM)
|
2.2%
1/45 • Number of events 1
|
|
Ear and labyrinth disorders
TINNITUS
|
6.7%
3/45 • Number of events 4
|
|
Renal and urinary disorders
URINARY FREQUENCY/URGENCY
|
11.1%
5/45 • Number of events 5
|
|
Renal and urinary disorders
URINARY RETENTION (INCLUDING NEUROGENIC BLADDER)
|
2.2%
1/45 • Number of events 1
|
|
Renal and urinary disorders
URINE COLOR CHANGE
|
2.2%
1/45 • Number of events 1
|
|
Eye disorders
VISION-BLURRED VISION
|
2.2%
1/45 • Number of events 1
|
|
Eye disorders
VISION-PHOTOPHOBIA
|
2.2%
1/45 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
VOICE CHANGES/DYSARTHRIA (E.G., HOARSENESS, LOSS OR ALTERATION IN VOICE, LARYNGITIS)
|
4.4%
2/45 • Number of events 2
|
|
Gastrointestinal disorders
VOMITING
|
33.3%
15/45 • Number of events 40
|
|
General disorders
WEIGHT LOSS
|
8.9%
4/45 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
WOUND COMPLICATION, NON-INFECTIOUS
|
2.2%
1/45 • Number of events 1
|
Additional Information
Principal Investigator
Hoosier Cancer Research Network, Inc.
Phone: 317-921-2050
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place