Trial Outcomes & Findings for Gemcitabine and Cisplatin as Neoadjuvant Chemotherapy in Patients With High-Grade Upper Tract Urothelial Carcinoma (NCT NCT01261728)
NCT ID: NCT01261728
Last Updated: 2026-09-02
Results Overview
of neoadjuvant Gemcitabine and Cisplatin/GC regimen in patients with upper tract high-grade urothelial carcinoma. Pathologic response to neoadjuvant GC is defined as the absence of high-grade carcinoma (\<pT2 disease) and the absence of microscopic lymph node metastases (N0) on the final nephroureterectomy specimen.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
57 participants
Primary outcome timeframe
up to 2 years
Results posted on
2026-09-02
Participant Flow
Participant milestones
| Measure |
Gemcitabine and Cisplatin
This is a Phase II Study of Gemcitabine and Cisplatin (GC) as neoadjuvant chemotherapy in patients with upper tract high-grade urothelial carcinoma who are candidates for radical nephroureterectomy or distal ureterectomy.
Gemcitabine and Cisplatin: Patients will receive four cycles of GC administered every 21 days.
Gemcitabine 1,000 mg/m2 and Cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8. A total of four cycles of therapy will be administered at 21 day intervals followed by radical nephroureterectomy or distal ureterectomy.
|
|---|---|
|
Overall Study
STARTED
|
57
|
|
Overall Study
COMPLETED
|
57
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gemcitabine and Cisplatin as Neoadjuvant Chemotherapy in Patients With High-Grade Upper Tract Urothelial Carcinoma
Baseline characteristics by cohort
| Measure |
Gemcitabine and Cisplatin
n=57 Participants
This is a Phase II Study of Gemcitabine and Cisplatin (GC) as neoadjuvant chemotherapy in patients with upper tract high-grade urothelial carcinoma who are candidates for radical nephroureterectomy or distal ureterectomy.
Gemcitabine and Cisplatin: Patients will receive four cycles of GC administered every 21 days.
Gemcitabine 1,000 mg/m2 and Cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8. A total of four cycles of therapy will be administered at 21 day intervals followed by radical nephroureterectomy or distal ureterectomy.
|
|---|---|
|
Age, Continuous
|
66 years
n=136 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=136 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=136 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=136 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=136 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=136 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=136 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=136 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=136 Participants
|
|
Region of Enrollment
United States
|
57 Participants
n=136 Participants
|
PRIMARY outcome
Timeframe: up to 2 yearsof neoadjuvant Gemcitabine and Cisplatin/GC regimen in patients with upper tract high-grade urothelial carcinoma. Pathologic response to neoadjuvant GC is defined as the absence of high-grade carcinoma (\<pT2 disease) and the absence of microscopic lymph node metastases (N0) on the final nephroureterectomy specimen.
Outcome measures
| Measure |
Gemcitabine and Cisplatin
n=57 Participants
This is a Phase II Study of Gemcitabine and Cisplatin (GC) as neoadjuvant chemotherapy in patients with upper tract high-grade urothelial carcinoma who are candidates for radical nephroureterectomy or distal ureterectomy.
Gemcitabine and Cisplatin: Patients will receive four cycles of GC administered every 21 days.
Gemcitabine 1,000 mg/m2 and Cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8. A total of four cycles of therapy will be administered at 21 day intervals followed by radical nephroureterectomy or distal ureterectomy.
|
|---|---|
|
Pathologic Response Rate (<pT2)
Met the end point of pathologic response
|
36 Participants
|
|
Pathologic Response Rate (<pT2)
Did not meet the end point of pathologic response
|
21 Participants
|
SECONDARY outcome
Timeframe: 2 yearswill be estimated using the methods of Kaplan and Meier in patients with upper tract high-grade urothelial carcinoma with neoadjuvant GC followed by radical nephroureterectomy.
Outcome measures
| Measure |
Gemcitabine and Cisplatin
n=57 Participants
This is a Phase II Study of Gemcitabine and Cisplatin (GC) as neoadjuvant chemotherapy in patients with upper tract high-grade urothelial carcinoma who are candidates for radical nephroureterectomy or distal ureterectomy.
Gemcitabine and Cisplatin: Patients will receive four cycles of GC administered every 21 days.
Gemcitabine 1,000 mg/m2 and Cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8. A total of four cycles of therapy will be administered at 21 day intervals followed by radical nephroureterectomy or distal ureterectomy.
|
|---|---|
|
Percentage of Participants With Progression Free Survival Rate
|
89 percentage of participants
Interval 81.0 to 98.0
|
SECONDARY outcome
Timeframe: 2 yearswill be estimated using the methods of Kaplan and Meier in patients with upper tract high-grade urothelial carcinoma treated with neoadjuvant GC followed by radical nephroureterectomy.
Outcome measures
| Measure |
Gemcitabine and Cisplatin
n=57 Participants
This is a Phase II Study of Gemcitabine and Cisplatin (GC) as neoadjuvant chemotherapy in patients with upper tract high-grade urothelial carcinoma who are candidates for radical nephroureterectomy or distal ureterectomy.
Gemcitabine and Cisplatin: Patients will receive four cycles of GC administered every 21 days.
Gemcitabine 1,000 mg/m2 and Cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8. A total of four cycles of therapy will be administered at 21 day intervals followed by radical nephroureterectomy or distal ureterectomy.
|
|---|---|
|
Overall Survival
Participants who died
|
11 Participants
|
|
Overall Survival
Participants who did not die
|
46 Participants
|
SECONDARY outcome
Timeframe: 2 yearsof neoadjuvant Gemcitabine and Cisplatin in this setting. Toxicity will be graded according to the National Cancer Institute Common Toxicity Criteria version 4.0.
Outcome measures
| Measure |
Gemcitabine and Cisplatin
n=57 Participants
This is a Phase II Study of Gemcitabine and Cisplatin (GC) as neoadjuvant chemotherapy in patients with upper tract high-grade urothelial carcinoma who are candidates for radical nephroureterectomy or distal ureterectomy.
Gemcitabine and Cisplatin: Patients will receive four cycles of GC administered every 21 days.
Gemcitabine 1,000 mg/m2 and Cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8. A total of four cycles of therapy will be administered at 21 day intervals followed by radical nephroureterectomy or distal ureterectomy.
|
|---|---|
|
Number of Participants Evaluated for Toxicity
|
57 Participants
|
Adverse Events
Gemcitabine and Cisplatin
Serious events: 22 serious events
Other events: 57 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Gemcitabine and Cisplatin
n=57 participants at risk
This is a Phase II Study of Gemcitabine and Cisplatin (GC) as neoadjuvant chemotherapy in patients with upper tract high-grade urothelial carcinoma who are candidates for radical nephroureterectomy or distal ureterectomy.
Gemcitabine and Cisplatin: Patients will receive four cycles of GC administered every 21 days.
Gemcitabine 1,000 mg/m2 and Cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8. A total of four cycles of therapy will be administered at 21 day intervals followed by radical nephroureterectomy or distal ureterectomy.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
7.0%
4/57 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
5.3%
3/57 • 2 years
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
1.8%
1/57 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
1.8%
1/57 • 2 years
|
|
General disorders
Pain
|
1.8%
1/57 • 2 years
|
|
Infections and infestations
Lung Infection
|
1.8%
1/57 • 2 years
|
|
Investigations
Lymphocyte count decreased
|
33.3%
19/57 • 2 years
|
|
Investigations
Neutrophil count decrease
|
31.6%
18/57 • 2 years
|
|
Investigations
WBC decreased
|
7.0%
4/57 • 2 years
|
|
Investigations
Platelet count decreased
|
7.0%
4/57 • 2 years
|
|
Investigations
Creatinine increased
|
5.3%
3/57 • 2 years
|
|
Investigations
ALT increased
|
3.5%
2/57 • 2 years
|
|
Investigations
Activated partial thomboplastin time prolonged
|
1.8%
1/57 • 2 years
|
|
Investigations
Lipase increased
|
1.8%
1/57 • 2 years
|
|
Investigations
Serum amylase increased
|
1.8%
1/57 • 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
14.0%
8/57 • 2 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
7.0%
4/57 • 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.3%
3/57 • 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.3%
3/57 • 2 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.5%
2/57 • 2 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
3.5%
2/57 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
1.8%
1/57 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
1.8%
1/57 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
1.8%
1/57 • 2 years
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
1.8%
1/57 • 2 years
|
|
Vascular disorders
Thromboembolic event
|
7.0%
4/57 • 2 years
|
|
Vascular disorders
Hypotension
|
1.8%
1/57 • 2 years
|
Other adverse events
| Measure |
Gemcitabine and Cisplatin
n=57 participants at risk
This is a Phase II Study of Gemcitabine and Cisplatin (GC) as neoadjuvant chemotherapy in patients with upper tract high-grade urothelial carcinoma who are candidates for radical nephroureterectomy or distal ureterectomy.
Gemcitabine and Cisplatin: Patients will receive four cycles of GC administered every 21 days.
Gemcitabine 1,000 mg/m2 and Cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8. A total of four cycles of therapy will be administered at 21 day intervals followed by radical nephroureterectomy or distal ureterectomy.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Papulopustular rash
|
1.8%
1/57 • 2 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
3.5%
2/57 • 2 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
31.6%
18/57 • 2 years
|
|
Vascular disorders
Phlebitis
|
24.6%
14/57 • 2 years
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
71.9%
41/57 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
1.8%
1/57 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
3.5%
2/57 • 2 years
|
|
Investigations
Proteinuria
|
1.8%
1/57 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.0%
4/57 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.3%
3/57 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
12.3%
7/57 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
19.3%
11/57 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash pustular
|
1.8%
1/57 • 2 years
|
|
Gastrointestinal disorders
Rectal pain
|
1.8%
1/57 • 2 years
|
|
Renal and urinary disorders
Renal disorder
|
1.8%
1/57 • 2 years
|
|
Infections and infestations
Rhinitis infective
|
1.8%
1/57 • 2 years
|
|
Investigations
Serum amylase increased
|
1.8%
1/57 • 2 years
|
|
Infections and infestations
Sinusitis
|
1.8%
1/57 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
1.8%
1/57 • 2 years
|
|
Infections and infestations
Skin infection
|
1.8%
1/57 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
3.5%
2/57 • 2 years
|
|
Gastrointestinal disorders
Stomach pain
|
1.8%
1/57 • 2 years
|
|
Vascular disorders
Superficial thrombophlebitis
|
1.8%
1/57 • 2 years
|
|
Vascular disorders
Thromboembolic event
|
15.8%
9/57 • 2 years
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
1.8%
1/57 • 2 years
|
|
Ear and labyrinth disorders
Tinnitus
|
28.1%
16/57 • 2 years
|
|
Gastrointestinal disorders
Toothache
|
1.8%
1/57 • 2 years
|
|
Infections and infestations
Upper respiratory infection
|
1.8%
1/57 • 2 years
|
|
Renal and urinary disorders
Urinary frequency
|
47.4%
27/57 • 2 years
|
|
Renal and urinary disorders
Urinary incontinence
|
12.3%
7/57 • 2 years
|
|
Infections and infestations
Urinary tract infection
|
3.5%
2/57 • 2 years
|
|
Renal and urinary disorders
Urinary retention
|
1.8%
1/57 • 2 years
|
|
Renal and urinary disorders
Urinary tract pain
|
28.1%
16/57 • 2 years
|
|
Renal and urinary disorders
Urinary urgency
|
1.8%
1/57 • 2 years
|
|
Reproductive system and breast disorders
Vaginal dryness
|
3.5%
2/57 • 2 years
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
1.8%
1/57 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
1.8%
1/57 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
3/57 • 2 years
|
|
Eye disorders
Watering eyes
|
3.5%
2/57 • 2 years
|
|
Investigations
Weight gain
|
3.5%
2/57 • 2 years
|
|
Investigations
Weight loss
|
10.5%
6/57 • 2 years
|
|
Investigations
White blood cell decreased
|
78.9%
45/57 • 2 years
|
|
Nervous system disorders
Dizziness
|
8.8%
5/57 • 2 years
|
|
Eye disorders
Dry eye
|
3.5%
2/57 • 2 years
|
|
Gastrointestinal disorders
Dry mouth
|
8.8%
5/57 • 2 years
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
7.0%
4/57 • 2 years
|
|
Nervous system disorders
Dysgeusia
|
19.3%
11/57 • 2 years
|
|
Gastrointestinal disorders
Dyspepsia
|
15.8%
9/57 • 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
3.5%
2/57 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
36.8%
21/57 • 2 years
|
|
General disorders
Edema limbs
|
19.3%
11/57 • 2 years
|
|
General disorders
Edema trunk
|
1.8%
1/57 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.5%
2/57 • 2 years
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
1.8%
1/57 • 2 years
|
|
General disorders
Fatigue
|
84.2%
48/57 • 2 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.0%
4/57 • 2 years
|
|
General disorders
Fever
|
7.0%
4/57 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
5.3%
3/57 • 2 years
|
|
Gastrointestinal disorders
Flatulence
|
3.5%
2/57 • 2 years
|
|
Eye disorders
Floaters
|
1.8%
1/57 • 2 years
|
|
General disorders
Gait disturbance
|
3.5%
2/57 • 2 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
10.5%
6/57 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
14.0%
8/57 • 2 years
|
|
Nervous system disorders
Headache
|
33.3%
19/57 • 2 years
|
|
Ear and labyrinth disorders
Hearing impaired
|
1.8%
1/57 • 2 years
|
|
Cardiac disorders
Heart failure
|
1.8%
1/57 • 2 years
|
|
Vascular disorders
Hematoma
|
3.5%
2/57 • 2 years
|
|
Renal and urinary disorders
Hematuria
|
26.3%
15/57 • 2 years
|
|
Investigations
Hemoglobin increased
|
5.3%
3/57 • 2 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
1.8%
1/57 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
5.3%
3/57 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
1.8%
1/57 • 2 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.5%
2/57 • 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
93.0%
53/57 • 2 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.8%
1/57 • 2 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
40.4%
23/57 • 2 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
8.8%
5/57 • 2 years
|
|
Vascular disorders
Hypertension
|
3.5%
2/57 • 2 years
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
19.3%
11/57 • 2 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
63.2%
36/57 • 2 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
78.9%
45/57 • 2 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
14.0%
8/57 • 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
14.0%
8/57 • 2 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
52.6%
30/57 • 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
33.3%
19/57 • 2 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
10.5%
6/57 • 2 years
|
|
Vascular disorders
Hypotension
|
1.8%
1/57 • 2 years
|
|
Endocrine disorders
Hypothyroidism
|
1.8%
1/57 • 2 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
1.8%
1/57 • 2 years
|
|
Injury, poisoning and procedural complications
Injection site reaction
|
5.3%
3/57 • 2 years
|
|
Investigations
INR increased
|
21.1%
12/57 • 2 years
|
|
Psychiatric disorders
Insomnia
|
14.0%
8/57 • 2 years
|
|
Nervous system disorders
Lethargy
|
1.8%
1/57 • 2 years
|
|
Investigations
Lipase increased
|
1.8%
1/57 • 2 years
|
|
General disorders
Localized edema
|
1.8%
1/57 • 2 years
|
|
Infections and infestations
Lung infection
|
1.8%
1/57 • 2 years
|
|
Investigations
Lymphocyte count decreased
|
49.1%
28/57 • 2 years
|
|
General disorders
Malaise
|
1.8%
1/57 • 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
15.8%
9/57 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
1.8%
1/57 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.8%
5/57 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.5%
6/57 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
50.9%
29/57 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.3%
3/57 • 2 years
|
|
Investigations
Neutrophil count decreased
|
63.2%
36/57 • 2 years
|
|
General disorders
Non-cardiac chest pain
|
3.5%
2/57 • 2 years
|
|
General disorders
Pain
|
21.1%
12/57 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.8%
1/57 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
1.8%
1/57 • 2 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
1.8%
1/57 • 2 years
|
|
Cardiac disorders
Palpitations
|
3.5%
2/57 • 2 years
|
|
Gastrointestinal disorders
Pancreatitis
|
1.8%
1/57 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.8%
5/57 • 2 years
|
|
Injury, poisoning and procedural complications
Aspartate aminotransferase increased
|
29.8%
17/57 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
21.1%
12/57 • 2 years
|
|
Infections and infestations
Bladder infection
|
1.8%
1/57 • 2 years
|
|
Gastrointestinal disorders
Bloating
|
5.3%
3/57 • 2 years
|
|
Investigations
Blood bilirubin increased
|
12.3%
7/57 • 2 years
|
|
Eye disorders
Blurred vision
|
7.0%
4/57 • 2 years
|
|
Cardiac disorders
Cardiac
|
1.8%
1/57 • 2 years
|
|
Cardiac disorders
Chest pain - cardiac
|
3.5%
2/57 • 2 years
|
|
General disorders
Chills
|
3.5%
2/57 • 2 years
|
|
Investigations
Cholesterol high
|
15.8%
9/57 • 2 years
|
|
Gastrointestinal disorders
Colitis
|
1.8%
1/57 • 2 years
|
|
Nervous system disorders
Concentration impairment
|
1.8%
1/57 • 2 years
|
|
Infections and infestations
Conjunctivitis
|
1.8%
1/57 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
52.6%
30/57 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.1%
16/57 • 2 years
|
|
Investigations
Creatinine increased
|
73.7%
42/57 • 2 years
|
|
Renal and urinary disorders
Cystitis noninfective
|
1.8%
1/57 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
1.8%
1/57 • 2 years
|
|
Psychiatric disorders
Depression
|
1.8%
1/57 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
15.8%
9/57 • 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
8.8%
5/57 • 2 years
|
|
Investigations
Activated partial thromboplastin time prolonged
|
21.1%
12/57 • 2 years
|
|
Renal and urinary disorders
Acute kidney injury
|
1.8%
1/57 • 2 years
|
|
Investigations
Alanine aminotransferase increased
|
42.1%
24/57 • 2 years
|
|
Investigations
Alkaline phosphatase increased
|
21.1%
12/57 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
7.0%
4/57 • 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
26.3%
15/57 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
10.5%
6/57 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
8.8%
5/57 • 2 years
|
|
Psychiatric disorders
Anxiety
|
14.0%
8/57 • 2 years
|
Additional Information
Dr. Jonathan Coleman, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-422-4432
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place