Trial Outcomes & Findings for S0350 Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Peripheral T-Cell Non-Hodgkin's Lymphoma (NCT NCT00109928)
NCT ID: NCT00109928
Last Updated: 2014-10-01
Results Overview
The overall survival rate is the percentage of patients who are alive 2 years after registration to the study. Overall survival is defined as the time between study registration and death due to any cause.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
0-2 years
Results posted on
2014-10-01
Participant Flow
Participant milestones
| Measure |
PEGS
Patients received IV cisplatin 25 mg/m2 days 1-4, etoposide 40 mg/m2 days 1-4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1-4 of a 21 day cycle for 6 cycles.
|
|---|---|
|
Overall Study
STARTED
|
34
|
|
Overall Study
Eligible
|
33
|
|
Overall Study
Eligible and Began Protocol Therapy
|
33
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
PEGS
Patients received IV cisplatin 25 mg/m2 days 1-4, etoposide 40 mg/m2 days 1-4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1-4 of a 21 day cycle for 6 cycles.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Progression
|
6
|
|
Overall Study
Death
|
2
|
|
Overall Study
not protocol specified
|
2
|
|
Overall Study
not eligible
|
1
|
Baseline Characteristics
S0350 Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Peripheral T-Cell Non-Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
PEGS
n=33 Participants
Patients received IV cisplatin 25 mg/m2 days 1-4, etoposide 40 mg/m2 days 1-4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1-4 of a 21 day cycle for 6 cycles.
|
|---|---|
|
Age, Continuous
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 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
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0-2 yearsPopulation: All eligible patients who started protocol treatment were included in the analysis
The overall survival rate is the percentage of patients who are alive 2 years after registration to the study. Overall survival is defined as the time between study registration and death due to any cause.
Outcome measures
| Measure |
PEGS
n=33 Participants
Patients received IV cisplatin 25 mg/m2 days 1-4, etoposide 40 mg/m2 days 1-4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1-4 of a 21 day cycle for 6 cycles.
|
|---|---|
|
2-year Overall Survival Rate
|
31 percentage of participants
Interval 8.0 to 54.0
|
SECONDARY outcome
Timeframe: 0-2 yearsPopulation: All eligible patients who started protocol treatment were included in the analysis.
Progression-free survival rate is the percentage of patients who do not show signs of progression at 2 years after registration to the study, including those whose disease has either completely or partially responded to treatment, or those whose disease is stable. Progression-free survival is defined as the time between study registration and documented progression, or death if no progression was observed.
Outcome measures
| Measure |
PEGS
n=33 Participants
Patients received IV cisplatin 25 mg/m2 days 1-4, etoposide 40 mg/m2 days 1-4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1-4 of a 21 day cycle for 6 cycles.
|
|---|---|
|
2-year Progression-free Survival Rate
|
12 percentage of participants
Interval 0.1 to 31.0
|
SECONDARY outcome
Timeframe: up to 3 years or time of disease progressionPopulation: All eligible patients who started protocol treatment were included in the analysis.
Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.
Outcome measures
| Measure |
PEGS
n=33 Participants
Patients received IV cisplatin 25 mg/m2 days 1-4, etoposide 40 mg/m2 days 1-4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1-4 of a 21 day cycle for 6 cycles.
|
|---|---|
|
Response Rate
Complete Response
|
6 participants
|
|
Response Rate
Unconfirmed Complete Response
|
2 participants
|
|
Response Rate
Partial Response
|
5 participants
|
|
Response Rate
No Response
|
20 participants
|
SECONDARY outcome
Timeframe: up to 18 weeks of protocol treatmentPopulation: Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.
Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
Outcome measures
| Measure |
PEGS
n=33 Participants
Patients received IV cisplatin 25 mg/m2 days 1-4, etoposide 40 mg/m2 days 1-4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1-4 of a 21 day cycle for 6 cycles.
|
|---|---|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Albumin, serum-low (hypoalbuminemia)
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Allergic reaction/hypersensitivity
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Anorexia
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Ataxia (incoordination)
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Auditory/Ear-Other (Specify)
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Blood/Bone Marrow-Other (Specify)
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Colitis, infectious (e.g., Clostridium difficile)
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Creatinine
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Diarrhea
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Dysphagia (difficulty swallowing)
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Dyspnea (shortness of breath)
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Fatigue (asthenia, lethargy, malaise)
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Febrile neutropenia
|
4 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Gastrointestinal-Other (Specify)
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Glucose, serum-high (hyperglycemia)
|
4 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Glucose, serum-low (hypoglycemia)
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Hemoglobin
|
9 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Hemorrhage, CNS
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Hypotension
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Incontinence, anal
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Blood
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Colon
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf w/normal ANC or Gr 1-2 neutrophils - Bladder
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf w/normal ANC or Gr 1-2 neutrophils - Lung
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Leukocytes (total WBC)
|
8 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Lymphopenia
|
7 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Magnesium, serum-low (hypomagnesemia)
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Nausea
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Neurology-Other (Specify)
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Neuropathy: motor
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Neuropathy: sensory
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Neutrophils/granulocytes (ANC/AGC)
|
16 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pain - Abdomen NOS
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Platelets
|
8 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Potassium, serum-low (hypokalemia)
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Renal failure
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Sodium, serum-low (hyponatremia)
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Thrombotic microangiopathy
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Tinnitus
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Tumor lysis syndrome
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Uric acid, serum-high (hyperuricemia)
|
1 Participants
|
Adverse Events
PEGS
Serious events: 5 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PEGS
n=33 participants at risk
Patients received IV cisplatin 25 mg/m2 days 1-4, etoposide 40 mg/m2 days 1-4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1-4 of a 21 day cycle for 6 cycles.)
|
|---|---|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
3.0%
1/33 • up to 18 weeks of protocol treatment
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Blood
|
3.0%
1/33 • up to 18 weeks of protocol treatment
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
3.0%
1/33 • up to 18 weeks of protocol treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death - Disease progression NOS
|
3.0%
1/33 • up to 18 weeks of protocol treatment
|
|
Nervous system disorders
Hemorrhage, CNS
|
3.0%
1/33 • up to 18 weeks of protocol treatment
|
Other adverse events
| Measure |
PEGS
n=33 participants at risk
Patients received IV cisplatin 25 mg/m2 days 1-4, etoposide 40 mg/m2 days 1-4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1-4 of a 21 day cycle for 6 cycles.)
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
15.2%
5/33 • up to 18 weeks of protocol treatment
|
|
Blood and lymphatic system disorders
Hemoglobin
|
84.8%
28/33 • up to 18 weeks of protocol treatment
|
|
Cardiac disorders
Cardiac General-Other
|
9.1%
3/33 • up to 18 weeks of protocol treatment
|
|
Cardiac disorders
Palpitations
|
6.1%
2/33 • up to 18 weeks of protocol treatment
|
|
Cardiac disorders
SVT and nodal arrhythmia - Sinus bradycardia
|
6.1%
2/33 • up to 18 weeks of protocol treatment
|
|
Cardiac disorders
SVT and nodal arrhythmia - Sinus tachycardia
|
9.1%
3/33 • up to 18 weeks of protocol treatment
|
|
Ear and labyrinth disorders
Auditory/Ear-Other
|
6.1%
2/33 • up to 18 weeks of protocol treatment
|
|
Ear and labyrinth disorders
Tinnitus
|
15.2%
5/33 • up to 18 weeks of protocol treatment
|
|
Eye disorders
Ocular/Visual-Other
|
6.1%
2/33 • up to 18 weeks of protocol treatment
|
|
Gastrointestinal disorders
Ascites (non-malignant)
|
6.1%
2/33 • up to 18 weeks of protocol treatment
|
|
Gastrointestinal disorders
Constipation
|
33.3%
11/33 • up to 18 weeks of protocol treatment
|
|
Gastrointestinal disorders
Diarrhea
|
42.4%
14/33 • up to 18 weeks of protocol treatment
|
|
Gastrointestinal disorders
Distention/bloating, abdominal
|
9.1%
3/33 • up to 18 weeks of protocol treatment
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
6.1%
2/33 • up to 18 weeks of protocol treatment
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
15.2%
5/33 • up to 18 weeks of protocol treatment
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
12.1%
4/33 • up to 18 weeks of protocol treatment
|
|
Gastrointestinal disorders
Nausea
|
72.7%
24/33 • up to 18 weeks of protocol treatment
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
24.2%
8/33 • up to 18 weeks of protocol treatment
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
11/33 • up to 18 weeks of protocol treatment
|
|
General disorders
Edema: head and neck
|
6.1%
2/33 • up to 18 weeks of protocol treatment
|
|
General disorders
Edema: limb
|
48.5%
16/33 • up to 18 weeks of protocol treatment
|
|
General disorders
Edema: trunk/genital
|
6.1%
2/33 • up to 18 weeks of protocol treatment
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
63.6%
21/33 • up to 18 weeks of protocol treatment
|
|
General disorders
Fever in absence of neutropenia, ANC lt1.0x10e9/L
|
18.2%
6/33 • up to 18 weeks of protocol treatment
|
|
General disorders
Injection site reaction/extravasation changes
|
6.1%
2/33 • up to 18 weeks of protocol treatment
|
|
General disorders
Pain - Chest/thorax NOS
|
6.1%
2/33 • up to 18 weeks of protocol treatment
|
|
General disorders
Pain-Other
|
27.3%
9/33 • up to 18 weeks of protocol treatment
|
|
General disorders
Rigors/chills
|
18.2%
6/33 • up to 18 weeks of protocol treatment
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
6.1%
2/33 • up to 18 weeks of protocol treatment
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Lung
|
6.1%
2/33 • up to 18 weeks of protocol treatment
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Oral cav
|
6.1%
2/33 • up to 18 weeks of protocol treatment
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Skin
|
9.1%
3/33 • up to 18 weeks of protocol treatment
|
|
Injury, poisoning and procedural complications
Bruising (in absence of Gr 3-4 thrombocytopenia)
|
6.1%
2/33 • up to 18 weeks of protocol treatment
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
12.1%
4/33 • up to 18 weeks of protocol treatment
|
|
Investigations
AST, SGOT
|
21.2%
7/33 • up to 18 weeks of protocol treatment
|
|
Investigations
Alkaline phosphatase
|
21.2%
7/33 • up to 18 weeks of protocol treatment
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
9.1%
3/33 • up to 18 weeks of protocol treatment
|
|
Investigations
Creatinine
|
45.5%
15/33 • up to 18 weeks of protocol treatment
|
|
Investigations
INR (of prothrombin time)
|
6.1%
2/33 • up to 18 weeks of protocol treatment
|
|
Investigations
Leukocytes (total WBC)
|
60.6%
20/33 • up to 18 weeks of protocol treatment
|
|
Investigations
Lymphopenia
|
33.3%
11/33 • up to 18 weeks of protocol treatment
|
|
Investigations
Metabolic/Laboratory-Other
|
6.1%
2/33 • up to 18 weeks of protocol treatment
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
63.6%
21/33 • up to 18 weeks of protocol treatment
|
|
Investigations
Platelets
|
54.5%
18/33 • up to 18 weeks of protocol treatment
|
|
Investigations
Weight gain
|
24.2%
8/33 • up to 18 weeks of protocol treatment
|
|
Investigations
Weight loss
|
12.1%
4/33 • up to 18 weeks of protocol treatment
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
39.4%
13/33 • up to 18 weeks of protocol treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
30.3%
10/33 • up to 18 weeks of protocol treatment
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
6.1%
2/33 • up to 18 weeks of protocol treatment
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
24.2%
8/33 • up to 18 weeks of protocol treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
12.1%
4/33 • up to 18 weeks of protocol treatment
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
45.5%
15/33 • up to 18 weeks of protocol treatment
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
9.1%
3/33 • up to 18 weeks of protocol treatment
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
27.3%
9/33 • up to 18 weeks of protocol treatment
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
6.1%
2/33 • up to 18 weeks of protocol treatment
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
6.1%
2/33 • up to 18 weeks of protocol treatment
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
12.1%
4/33 • up to 18 weeks of protocol treatment
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
21.2%
7/33 • up to 18 weeks of protocol treatment
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
12.1%
4/33 • up to 18 weeks of protocol treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, not d/t neuropathy - body/general
|
18.2%
6/33 • up to 18 weeks of protocol treatment
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
18.2%
6/33 • up to 18 weeks of protocol treatment
|
|
Musculoskeletal and connective tissue disorders
Pain - Bone
|
12.1%
4/33 • up to 18 weeks of protocol treatment
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
12.1%
4/33 • up to 18 weeks of protocol treatment
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
6.1%
2/33 • up to 18 weeks of protocol treatment
|
|
Musculoskeletal and connective tissue disorders
Pain - Neck
|
9.1%
3/33 • up to 18 weeks of protocol treatment
|
|
Nervous system disorders
Dizziness
|
18.2%
6/33 • up to 18 weeks of protocol treatment
|
|
Nervous system disorders
Neurology-Other
|
12.1%
4/33 • up to 18 weeks of protocol treatment
|
|
Nervous system disorders
Neuropathy: sensory
|
33.3%
11/33 • up to 18 weeks of protocol treatment
|
|
Nervous system disorders
Ocular/Visual-Other
|
6.1%
2/33 • up to 18 weeks of protocol treatment
|
|
Nervous system disorders
Pain - Head/headache
|
18.2%
6/33 • up to 18 weeks of protocol treatment
|
|
Nervous system disorders
Seizure
|
6.1%
2/33 • up to 18 weeks of protocol treatment
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
15.2%
5/33 • up to 18 weeks of protocol treatment
|
|
Psychiatric disorders
Confusion
|
12.1%
4/33 • up to 18 weeks of protocol treatment
|
|
Psychiatric disorders
Insomnia
|
27.3%
9/33 • up to 18 weeks of protocol treatment
|
|
Psychiatric disorders
Mood alteration - agitation
|
6.1%
2/33 • up to 18 weeks of protocol treatment
|
|
Psychiatric disorders
Mood alteration - anxiety
|
27.3%
9/33 • up to 18 weeks of protocol treatment
|
|
Psychiatric disorders
Mood alteration - depression
|
6.1%
2/33 • up to 18 weeks of protocol treatment
|
|
Renal and urinary disorders
Glomerular filtration rate
|
6.1%
2/33 • up to 18 weeks of protocol treatment
|
|
Renal and urinary disorders
Renal failure
|
9.1%
3/33 • up to 18 weeks of protocol treatment
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
6.1%
2/33 • up to 18 weeks of protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
6.1%
2/33 • up to 18 weeks of protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
24.2%
8/33 • up to 18 weeks of protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
36.4%
12/33 • up to 18 weeks of protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Nose
|
6.1%
2/33 • up to 18 weeks of protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
6.1%
2/33 • up to 18 weeks of protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
9.1%
3/33 • up to 18 weeks of protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
6.1%
2/33 • up to 18 weeks of protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-Other
|
9.1%
3/33 • up to 18 weeks of protocol treatment
|
|
Skin and subcutaneous tissue disorders
Hair loss/Alopecia (scalp or body)
|
45.5%
15/33 • up to 18 weeks of protocol treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
15.2%
5/33 • up to 18 weeks of protocol treatment
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
9.1%
3/33 • up to 18 weeks of protocol treatment
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
15.2%
5/33 • up to 18 weeks of protocol treatment
|
|
Vascular disorders
Hypertension
|
21.2%
7/33 • up to 18 weeks of protocol treatment
|
|
Vascular disorders
Hypotension
|
21.2%
7/33 • up to 18 weeks of protocol treatment
|
Additional Information
Study Statistician
SWOG Statistical Center
Phone: 206-667-4623
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place