Trial Outcomes & Findings for Glutathione in Preventing Peripheral Neuropathy Caused by Paclitaxel and Carboplatin in Patients With Ovarian Cancer, Fallopian Tube Cancer, and/or Primary Peritoneal Cancer (NCT NCT02311907)
NCT ID: NCT02311907
Last Updated: 2017-02-23
Results Overview
The CIPN sensory subscale will be calculated by standard scoring algorithm and converted to 0-100 scale (higher scores indicated less symptoms and better quality of life). Generalized linear models (repeated measures analysis of variance \[ANOVA\] if data are complete) will be used to compare the CIPN between Glutathione (GSH) and placebo arms.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
195 participants
Primary outcome timeframe
Every 28 day cycle, up to 6 cycles.
Results posted on
2017-02-23
Participant Flow
Total of 195 patients were enrolled, 185 started the treatment (8 cancels, 1 ineligible and 1 excluded due to switching regimens).
Participant milestones
| Measure |
A (Glutathione, Carboplatin)
Patients receive glutathione IV over 15 minutes, paclitaxel\* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
|
B (Placebo, Paclitaxel)
Patients receive placebo IV over 15 minutes, paclitaxel\* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
|
|---|---|---|
|
Overall Study
STARTED
|
94
|
91
|
|
Overall Study
COMPLETED
|
94
|
91
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Glutathione in Preventing Peripheral Neuropathy Caused by Paclitaxel and Carboplatin in Patients With Ovarian Cancer, Fallopian Tube Cancer, and/or Primary Peritoneal Cancer
Baseline characteristics by cohort
| Measure |
A (Glutathione, Carboplatin)
n=94 Participants
Patients receive glutathione IV over 15 minutes, paclitaxel\* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
|
B (Placebo, Paclitaxel)
n=91 Participants
Patients receive placebo IV over 15 minutes, paclitaxel\* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
|
Total
n=185 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
n=99 Participants
|
63 years
n=107 Participants
|
63 years
n=206 Participants
|
|
Gender
Female
|
74 Participants
n=99 Participants
|
76 Participants
n=107 Participants
|
150 Participants
n=206 Participants
|
|
Gender
Male
|
20 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
94 participants
n=99 Participants
|
91 participants
n=107 Participants
|
185 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Every 28 day cycle, up to 6 cycles.The CIPN sensory subscale will be calculated by standard scoring algorithm and converted to 0-100 scale (higher scores indicated less symptoms and better quality of life). Generalized linear models (repeated measures analysis of variance \[ANOVA\] if data are complete) will be used to compare the CIPN between Glutathione (GSH) and placebo arms.
Outcome measures
| Measure |
A (Glutathione, Carboplatin)
n=94 Participants
Patients receive glutathione IV over 15 minutes, paclitaxel\* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
|
B (Placebo, Paclitaxel)
n=91 Participants
Patients receive placebo IV over 15 minutes, paclitaxel\* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
|
|---|---|---|
|
Paclitaxel/Carboplatin (PC) Induced Peripheral Neuropathy as Assessed by EORTC QLQ-CIPN20 (European Organization for Research and Treatment of Cancer (EORTC), Quality of Life (QLQ), Chemotherapy Induced Peripheral Neuropathy 20 (CIPN20)).
|
83.7 Units on a scale 1-100
Standard Error 0.89
|
82.1 Units on a scale 1-100
Standard Error 0.93
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Patients without clinical evidence of disease.
A log-rank test and a Kaplan-Meier curve will be used to compare the recurrence free survival between GSH and placebo arms (for ovarian/fallopian tube/primary peritoneal patients only).
Outcome measures
| Measure |
A (Glutathione, Carboplatin)
n=45 Participants
Patients receive glutathione IV over 15 minutes, paclitaxel\* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
|
B (Placebo, Paclitaxel)
n=40 Participants
Patients receive placebo IV over 15 minutes, paclitaxel\* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
|
|---|---|---|
|
Recurrence-free Survival (for Patients Without Clinical Evidence of Disease)
|
NA Median survival time in days
Insufficient number of participants with events.
|
NA Median survival time in days
Insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Baseline to 1 yearPopulation: FACT-O Change from Baseline to cycle 6 data available for 34 patients.
Quality of life was measured by FACT-O (on a 0 to 100 scale, higher scores represent better life quality) from baseline and at the end of TAXOL/CBDCA. The change in Quality of Life was calculated as the difference between baseline measure and end of treatment measure (with range from -100 to 100). A negative change represents a worsening in QOL from baseline to one year. Abbreviations used: Change from Baseline (chg from bsl)
Outcome measures
| Measure |
A (Glutathione, Carboplatin)
n=17 Participants
Patients receive glutathione IV over 15 minutes, paclitaxel\* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
|
B (Placebo, Paclitaxel)
n=17 Participants
Patients receive placebo IV over 15 minutes, paclitaxel\* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
|
|---|---|---|
|
Change in Patient Reported Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Ovarian (FACT-O) and Patient Daily-symptom Questionnaires Over Time.
FACT-O Physical Subscale Chg from Bsl
|
-14.3 units on a scale
Interval -57.1 to 57.1
|
-8.9 units on a scale
Interval -75.0 to 14.3
|
|
Change in Patient Reported Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Ovarian (FACT-O) and Patient Daily-symptom Questionnaires Over Time.
FACT-O Social/Family Subscale Chg from Bsl
|
-4.2 units on a scale
Interval -28.6 to 4.2
|
0.0 units on a scale
Interval -100.0 to 21.4
|
|
Change in Patient Reported Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Ovarian (FACT-O) and Patient Daily-symptom Questionnaires Over Time.
FACT-O Emotional Subscale Chg from Bsl
|
8.3 units on a scale
Interval -45.8 to 37.5
|
4.2 units on a scale
Interval -20.8 to 45.8
|
|
Change in Patient Reported Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Ovarian (FACT-O) and Patient Daily-symptom Questionnaires Over Time.
FACT-O Functional Subscale Chg from Bsl
|
0.0 units on a scale
Interval -32.1 to 21.4
|
5.1 units on a scale
Interval -96.4 to 42.9
|
|
Change in Patient Reported Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Ovarian (FACT-O) and Patient Daily-symptom Questionnaires Over Time.
FACT-O Additional Concerns Subscale Chg from Bsl
|
-2.3 units on a scale
Interval -22.7 to 20.5
|
4.8 units on a scale
Interval -29.5 to 19.8
|
|
Change in Patient Reported Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Ovarian (FACT-O) and Patient Daily-symptom Questionnaires Over Time.
FACT-O Total Score Chg from Bsl
|
0.3 units on a scale
Interval -27.6 to 13.3
|
4.4 units on a scale
Interval -39.5 to 16.1
|
SECONDARY outcome
Timeframe: Up to 1 yearDescriptive statistics will be used to describe TAXOL/CBDCA acute pain syndrome incidence/severity between GSH and placebo arms. Pain was scored on a scale from 0-10, where 0 = 'No aches or pains' and 10 = 'Aches or pains as bad as can be.'
Outcome measures
| Measure |
A (Glutathione, Carboplatin)
n=94 Participants
Patients receive glutathione IV over 15 minutes, paclitaxel\* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
|
B (Placebo, Paclitaxel)
n=91 Participants
Patients receive placebo IV over 15 minutes, paclitaxel\* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
|
|---|---|---|
|
Paclitaxel Acute Pain Syndrome Incidence and Severity Between GSH and Placebo Arms
|
2.0 units on a scale
Interval 0.0 to 10.0
|
2.0 units on a scale
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: Up to 1 yearPatients delaying TAXOL/CBDCA secondary to peripheral neuropathy between GSH and placebo arms.
Outcome measures
| Measure |
A (Glutathione, Carboplatin)
n=94 Participants
Patients receive glutathione IV over 15 minutes, paclitaxel\* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
|
B (Placebo, Paclitaxel)
n=91 Participants
Patients receive placebo IV over 15 minutes, paclitaxel\* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
|
|---|---|---|
|
Percentage of Patients Delaying PC Chemotherapy Secondary to PN
|
1.1 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 1 yearProportion of patients requiring chemotherapy dose reductions secondary to TAXOL/CBDCA induced peripheral neuropathy between GSH and placebo arms.
Outcome measures
| Measure |
A (Glutathione, Carboplatin)
n=94 Participants
Patients receive glutathione IV over 15 minutes, paclitaxel\* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
|
B (Placebo, Paclitaxel)
n=91 Participants
Patients receive placebo IV over 15 minutes, paclitaxel\* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
|
|---|---|---|
|
Percentage of Patients Undergoing Dose Reductions Secondary to PCI PN
Reduced TAXOL Dose : Yes
|
2.1 percentage of participants
|
1.1 percentage of participants
|
|
Percentage of Patients Undergoing Dose Reductions Secondary to PCI PN
Reduced CARBO Dose: Yes
|
1.1 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 1 yearProportion of grade 2+ and grade 3+ chemotherapy induced peripheral neuropathy (CIPN) at any time during or at the end of the TAXOL/CBDCA based chemotherapy between GSH and placebo arms. Neuropathy scale has grades 1 through 5 (1-mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening and Grade 5 Death related to AE).
Outcome measures
| Measure |
A (Glutathione, Carboplatin)
n=94 Participants
Patients receive glutathione IV over 15 minutes, paclitaxel\* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
|
B (Placebo, Paclitaxel)
n=91 Participants
Patients receive placebo IV over 15 minutes, paclitaxel\* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
|
|---|---|---|
|
Percentage of Patients With Grade 2+ and Grade 3+ Paclitaxel/Carboplatin-induced (PCI) Peripheral Neuropathy (PN) According to the Common Terminology Criteria for Adverse Events (CTCAE) Neuropathy Scale
Grade 2+ CIPN: Yes
|
38.3 percentage of participants
|
33.0 percentage of participants
|
|
Percentage of Patients With Grade 2+ and Grade 3+ Paclitaxel/Carboplatin-induced (PCI) Peripheral Neuropathy (PN) According to the Common Terminology Criteria for Adverse Events (CTCAE) Neuropathy Scale
Grade 3+ CIPN: Yes
|
5.3 percentage of participants
|
4.4 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Number of Participants analyzed is 93 for Arm I due to error in date entered.
Compare time to grade 2+ CIPN between GSH and placebo arms.
Outcome measures
| Measure |
A (Glutathione, Carboplatin)
n=93 Participants
Patients receive glutathione IV over 15 minutes, paclitaxel\* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
|
B (Placebo, Paclitaxel)
n=91 Participants
Patients receive placebo IV over 15 minutes, paclitaxel\* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
|
|---|---|---|
|
Times to Onset of CTCAE Grade 2+ PN
|
140 days
Standard Error 18.5
|
234 days
Standard Error 26.1
|
SECONDARY outcome
Timeframe: Up to 5 years from registrationTime to grade 3+ CIPN between GSH and placebo arms.
Outcome measures
| Measure |
A (Glutathione, Carboplatin)
n=94 Participants
Patients receive glutathione IV over 15 minutes, paclitaxel\* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
|
B (Placebo, Paclitaxel)
n=91 Participants
Patients receive placebo IV over 15 minutes, paclitaxel\* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
|
|---|---|---|
|
Times to Onset of CTCAE Grade 3+ PN
|
NA days
Insufficient number of participants with events
|
NA days
Insufficient number of participants with events
|
Adverse Events
A (Glutathione, Carboplatin)
Serious events: 7 serious events
Other events: 64 other events
Deaths: 0 deaths
B (Placebo, Paclitaxel)
Serious events: 1 serious events
Other events: 62 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
A (Glutathione, Carboplatin)
n=94 participants at risk
Quality-of-Life Assessment: Ancillary studies
|
B (Placebo, Paclitaxel)
n=91 participants at risk
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.1%
1/94 • Number of events 1
|
0.00%
0/91
|
|
General disorders
Pain
|
1.1%
1/94 • Number of events 1
|
0.00%
0/91
|
|
Infections and infestations
Lung infection
|
0.00%
0/94
|
1.1%
1/91 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
1.1%
1/94 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
|
Investigations
White blood cell decreased
|
0.00%
0/94
|
1.1%
1/91 • Number of events 1
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.1%
1/94 • Number of events 1
|
0.00%
0/91
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.1%
1/94 • Number of events 2
|
0.00%
0/91
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/94
|
1.1%
1/91 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/94
|
1.1%
1/91 • Number of events 1
|
|
Vascular disorders
Thromboembolic event
|
3.2%
3/94 • Number of events 3
|
0.00%
0/91
|
Other adverse events
| Measure |
A (Glutathione, Carboplatin)
n=94 participants at risk
Quality-of-Life Assessment: Ancillary studies
|
B (Placebo, Paclitaxel)
n=91 participants at risk
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
12.8%
12/94 • Number of events 22
|
16.5%
15/91 • Number of events 28
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.00%
0/94
|
1.1%
1/91 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.1%
1/94 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.1%
1/94 • Number of events 2
|
0.00%
0/91
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/94
|
1.1%
1/91 • Number of events 1
|
|
Cardiac disorders
Heart failure
|
0.00%
0/94
|
1.1%
1/91 • Number of events 1
|
|
Cardiac disorders
Pericardial effusion
|
1.1%
1/94 • Number of events 1
|
0.00%
0/91
|
|
Cardiac disorders
Pericardial tamponade
|
0.00%
0/94
|
1.1%
1/91 • Number of events 1
|
|
Ear and labyrinth disorders
Hearing impaired
|
1.1%
1/94 • Number of events 2
|
0.00%
0/91
|
|
Gastrointestinal disorders
Abdominal distension
|
1.1%
1/94 • Number of events 1
|
0.00%
0/91
|
|
Gastrointestinal disorders
Abdominal pain
|
3.2%
3/94 • Number of events 3
|
2.2%
2/91 • Number of events 2
|
|
Gastrointestinal disorders
Colonic obstruction
|
1.1%
1/94 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
3.2%
3/94 • Number of events 3
|
4.4%
4/91 • Number of events 7
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/94
|
3.3%
3/91 • Number of events 3
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
0/94
|
1.1%
1/91 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
2.1%
2/94 • Number of events 4
|
0.00%
0/91
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
1.1%
1/94 • Number of events 1
|
0.00%
0/91
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/94
|
1.1%
1/91 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
3.2%
3/94 • Number of events 3
|
4.4%
4/91 • Number of events 4
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
1.1%
1/94 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
|
Gastrointestinal disorders
Rectal ulcer
|
0.00%
0/94
|
1.1%
1/91 • Number of events 1
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.1%
1/94 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/94
|
1.1%
1/91 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
2/94 • Number of events 2
|
4.4%
4/91 • Number of events 4
|
|
General disorders
Death NOS
|
3.2%
3/94 • Number of events 3
|
2.2%
2/91 • Number of events 3
|
|
General disorders
Edema limbs
|
2.1%
2/94 • Number of events 3
|
0.00%
0/91
|
|
General disorders
Edema trunk
|
1.1%
1/94 • Number of events 2
|
0.00%
0/91
|
|
General disorders
Fatigue
|
10.6%
10/94 • Number of events 18
|
9.9%
9/91 • Number of events 11
|
|
General disorders
Infusion related reaction
|
1.1%
1/94 • Number of events 1
|
0.00%
0/91
|
|
General disorders
Pain
|
1.1%
1/94 • Number of events 1
|
2.2%
2/91 • Number of events 2
|
|
Immune system disorders
Anaphylaxis
|
2.1%
2/94 • Number of events 2
|
0.00%
0/91
|
|
Infections and infestations
Anorectal infection
|
1.1%
1/94 • Number of events 1
|
0.00%
0/91
|
|
Infections and infestations
Bladder infection
|
1.1%
1/94 • Number of events 3
|
0.00%
0/91
|
|
Infections and infestations
Enterocolitis infectious
|
1.1%
1/94 • Number of events 1
|
0.00%
0/91
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/94
|
1.1%
1/91 • Number of events 1
|
|
Infections and infestations
Lung infection
|
2.1%
2/94 • Number of events 2
|
0.00%
0/91
|
|
Infections and infestations
Nail infection
|
1.1%
1/94 • Number of events 1
|
0.00%
0/91
|
|
Infections and infestations
Papulopustular rash
|
1.1%
1/94 • Number of events 1
|
0.00%
0/91
|
|
Infections and infestations
Paronychia
|
1.1%
1/94 • Number of events 1
|
0.00%
0/91
|
|
Infections and infestations
Sepsis
|
1.1%
1/94 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
|
Infections and infestations
Skin infection
|
1.1%
1/94 • Number of events 3
|
0.00%
0/91
|
|
Infections and infestations
Soft tissue infection
|
1.1%
1/94 • Number of events 1
|
0.00%
0/91
|
|
Infections and infestations
Tooth infection
|
1.1%
1/94 • Number of events 1
|
0.00%
0/91
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/94
|
2.2%
2/91 • Number of events 3
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/94
|
3.3%
3/91 • Number of events 3
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/94
|
1.1%
1/91 • Number of events 1
|
|
Injury, poisoning and procedural complications
Intraoperative ocular injury
|
0.00%
0/94
|
1.1%
1/91 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
1.1%
1/94 • Number of events 1
|
0.00%
0/91
|
|
Investigations
Aspartate aminotransferase increased
|
1.1%
1/94 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
|
Investigations
Hemoglobin increased
|
1.1%
1/94 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
|
Investigations
INR increased
|
2.1%
2/94 • Number of events 2
|
0.00%
0/91
|
|
Investigations
Lymphocyte count decreased
|
4.3%
4/94 • Number of events 5
|
7.7%
7/91 • Number of events 15
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/94
|
1.1%
1/91 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
23.4%
22/94 • Number of events 44
|
18.7%
17/91 • Number of events 31
|
|
Investigations
Platelet count decreased
|
6.4%
6/94 • Number of events 8
|
11.0%
10/91 • Number of events 18
|
|
Investigations
Weight gain
|
1.1%
1/94 • Number of events 2
|
0.00%
0/91
|
|
Investigations
White blood cell decreased
|
9.6%
9/94 • Number of events 13
|
9.9%
9/91 • Number of events 14
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/94
|
1.1%
1/91 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
6.4%
6/94 • Number of events 7
|
3.3%
3/91 • Number of events 3
|
|
Metabolism and nutrition disorders
Dehydration
|
1.1%
1/94 • Number of events 1
|
3.3%
3/91 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.1%
2/94 • Number of events 6
|
5.5%
5/91 • Number of events 8
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
1.1%
1/94 • Number of events 1
|
0.00%
0/91
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.1%
1/94 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.1%
2/94 • Number of events 2
|
1.1%
1/91 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.1%
2/94 • Number of events 2
|
2.2%
2/91 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.1%
1/94 • Number of events 1
|
0.00%
0/91
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
1.1%
1/94 • Number of events 1
|
2.2%
2/91 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/94
|
1.1%
1/91 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.1%
1/94 • Number of events 1
|
2.2%
2/91 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.1%
2/94 • Number of events 2
|
4.4%
4/91 • Number of events 5
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/94
|
2.2%
2/91 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/94
|
1.1%
1/91 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
1.1%
1/94 • Number of events 1
|
0.00%
0/91
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/94
|
1.1%
1/91 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/94
|
1.1%
1/91 • Number of events 1
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/94
|
1.1%
1/91 • Number of events 1
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/94
|
1.1%
1/91 • Number of events 1
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.1%
1/94 • Number of events 2
|
1.1%
1/91 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
12.8%
12/94 • Number of events 20
|
7.7%
7/91 • Number of events 12
|
|
Nervous system disorders
Syncope
|
0.00%
0/94
|
2.2%
2/91 • Number of events 2
|
|
Psychiatric disorders
Anxiety
|
1.1%
1/94 • Number of events 1
|
0.00%
0/91
|
|
Psychiatric disorders
Depression
|
1.1%
1/94 • Number of events 1
|
0.00%
0/91
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/94
|
2.2%
2/91 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
2.1%
2/94 • Number of events 2
|
0.00%
0/91
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
1/94 • Number of events 2
|
0.00%
0/91
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.2%
3/94 • Number of events 4
|
3.3%
3/91 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.1%
1/94 • Number of events 1
|
0.00%
0/91
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.1%
1/94 • Number of events 1
|
2.2%
2/91 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/94
|
2.2%
2/91 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/94
|
1.1%
1/91 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.1%
1/94 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.1%
1/94 • Number of events 2
|
0.00%
0/91
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.4%
7/94 • Number of events 11
|
4.4%
4/91 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.1%
1/94 • Number of events 1
|
0.00%
0/91
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/94
|
1.1%
1/91 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.1%
1/94 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.1%
1/94 • Number of events 1
|
0.00%
0/91
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.1%
1/94 • Number of events 1
|
0.00%
0/91
|
|
Vascular disorders
Hot flashes
|
1.1%
1/94 • Number of events 1
|
0.00%
0/91
|
|
Vascular disorders
Hypertension
|
1.1%
1/94 • Number of events 2
|
6.6%
6/91 • Number of events 7
|
|
Vascular disorders
Hypotension
|
0.00%
0/94
|
1.1%
1/91 • Number of events 2
|
|
Vascular disorders
Thromboembolic event
|
5.3%
5/94 • Number of events 6
|
1.1%
1/91 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place