Trial Outcomes & Findings for Imatinib and Rituximab in Treating Cutaneous Sclerosis in Patients With Chronic Graft-Versus-Host Disease (NCT NCT01309997)
NCT ID: NCT01309997
Last Updated: 2016-06-15
Results Overview
Assessed by decline in an affected area's skin score as measured with the Vienna Skin Scale (from 4 \[worst\] to 2, 3 to 1, or 2 to 0 \[best\]) without a concurrent increase of two or more points in another area OR by an increase in the range of motion of the shoulders, elbows or wrists by two points (in a 1-7 scale where 1 is worst and 7 is best) or of the ankles by one point (in a 1 to 4 scale where 1 is worst and 4 is best) without a concurrent worsening in another area.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
72 participants
Primary outcome timeframe
6 months
Results posted on
2016-06-15
Participant Flow
Participant milestones
| Measure |
Arm I (Enzyme Inhibitor)
Patients receive imatinib mesylate PO QD for 6 months in the absence of progression of sclerosis or unacceptable toxicity. During the 6mo study treatment period, if drug intolerance or disease progression is observed, they are crossed over to rituximab.
|
Arm II (Monoclonal Antibody)
Patients receive rituximab IV on days 1, 8, 15, and 22. A second treatment cycle is repeated at 3 months for a total of 8 doses of rituximab in the absence of progression of sclerosis or unacceptable toxicity. During the 6mo study treatment period, if drug intolerance or disease progression is observed, they are crossed over to imatinib.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
37
|
|
Overall Study
Remained on First Arm Only
|
16
|
14
|
|
Overall Study
Crossed Over to Second Arm
|
19
|
23
|
|
Overall Study
COMPLETED
|
30
|
31
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
| Measure |
Arm I (Enzyme Inhibitor)
Patients receive imatinib mesylate PO QD for 6 months in the absence of progression of sclerosis or unacceptable toxicity. During the 6mo study treatment period, if drug intolerance or disease progression is observed, they are crossed over to rituximab.
|
Arm II (Monoclonal Antibody)
Patients receive rituximab IV on days 1, 8, 15, and 22. A second treatment cycle is repeated at 3 months for a total of 8 doses of rituximab in the absence of progression of sclerosis or unacceptable toxicity. During the 6mo study treatment period, if drug intolerance or disease progression is observed, they are crossed over to imatinib.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Death
|
1
|
3
|
|
Overall Study
Lack of Efficacy
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Imatinib and Rituximab in Treating Cutaneous Sclerosis in Patients With Chronic Graft-Versus-Host Disease
Baseline characteristics by cohort
| Measure |
Arm I (Enzyme Inhibitor)
n=35 Participants
Patients receive imatinib mesylate PO QD for 6 months in the absence of progression of sclerosis or unacceptable toxicity. During the 6mo study treatment period, if drug intolerance or disease progression is observed, they are crossed over to rituximab.
|
Arm II (Monoclonal Antibody)
n=37 Participants
Patients receive rituximab IV on days 1, 8, 15, and 22. A second treatment cycle is repeated at 3 months for a total of 8 doses of rituximab in the absence of progression of sclerosis or unacceptable toxicity. TDuring the 6mo study treatment period, if drug intolerance or disease progression is observed, they are crossed over to imatinib.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Patients were not eligible for evaluation if they discontinued participation or had missing 6 mo data.
Assessed by decline in an affected area's skin score as measured with the Vienna Skin Scale (from 4 \[worst\] to 2, 3 to 1, or 2 to 0 \[best\]) without a concurrent increase of two or more points in another area OR by an increase in the range of motion of the shoulders, elbows or wrists by two points (in a 1-7 scale where 1 is worst and 7 is best) or of the ankles by one point (in a 1 to 4 scale where 1 is worst and 4 is best) without a concurrent worsening in another area.
Outcome measures
| Measure |
Arm I (Enzyme Inhibitor)
n=30 Participants
Patients who were randomized to receive imatinib mesylate PO QD for 6 months in the absence of progression of sclerosis or unacceptable toxicity.
|
Arm II (Monoclonal Antibody)
n=31 Participants
Patients who were randomized to receive rituximab IV on days 1, 8, 15, and 22. A second treatment cycle was repeated at 3 months for a total of 8 doses of rituximab in the absence of progression of sclerosis or unacceptable toxicity.
|
Imatinib Responders
Attained a SCR with imatinib
|
Imatinib Nonresponders
Did not attain a SCR with imatinib
|
|---|---|---|---|---|
|
Significant Clinical Response
|
9 participants
|
10 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Patients with no corticosteroid dose data missing from baseline or 6mo.
Patients who achieved a greater than or equal to 50% reduction in the daily corticosteroid dose at 6mo compared to baseline
Outcome measures
| Measure |
Arm I (Enzyme Inhibitor)
n=27 Participants
Patients who were randomized to receive imatinib mesylate PO QD for 6 months in the absence of progression of sclerosis or unacceptable toxicity.
|
Arm II (Monoclonal Antibody)
n=32 Participants
Patients who were randomized to receive rituximab IV on days 1, 8, 15, and 22. A second treatment cycle was repeated at 3 months for a total of 8 doses of rituximab in the absence of progression of sclerosis or unacceptable toxicity.
|
Imatinib Responders
Attained a SCR with imatinib
|
Imatinib Nonresponders
Did not attain a SCR with imatinib
|
|---|---|---|---|---|
|
Patients Who Were Able to Taper Corticosteroids
|
7 participants
|
9 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Only patients who were evaluable for SCR are included.
Defined as discontinuation of randomized treatment due to chronic GVHD progression or treatment intolerance or no significant clinical response in sclerosis.
Outcome measures
| Measure |
Arm I (Enzyme Inhibitor)
n=30 Participants
Patients who were randomized to receive imatinib mesylate PO QD for 6 months in the absence of progression of sclerosis or unacceptable toxicity.
|
Arm II (Monoclonal Antibody)
n=31 Participants
Patients who were randomized to receive rituximab IV on days 1, 8, 15, and 22. A second treatment cycle was repeated at 3 months for a total of 8 doses of rituximab in the absence of progression of sclerosis or unacceptable toxicity.
|
Imatinib Responders
Attained a SCR with imatinib
|
Imatinib Nonresponders
Did not attain a SCR with imatinib
|
|---|---|---|---|---|
|
Cumulative Incidence of Treatment Failure
|
24 participants
|
26 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Only patients evaluable at 6 mo are included.
Assessed by decrease of \>= 0.2 units (where 0 is best and 3.0 is worst ) in the Scleroderma Health Assessment Questionnaire (SHAQ).
Outcome measures
| Measure |
Arm I (Enzyme Inhibitor)
n=30 Participants
Patients who were randomized to receive imatinib mesylate PO QD for 6 months in the absence of progression of sclerosis or unacceptable toxicity.
|
Arm II (Monoclonal Antibody)
n=31 Participants
Patients who were randomized to receive rituximab IV on days 1, 8, 15, and 22. A second treatment cycle was repeated at 3 months for a total of 8 doses of rituximab in the absence of progression of sclerosis or unacceptable toxicity.
|
Imatinib Responders
Attained a SCR with imatinib
|
Imatinib Nonresponders
Did not attain a SCR with imatinib
|
|---|---|---|---|---|
|
Number of Patients Achieving Improvement in Cutaneous Sclerosis
|
2 participants
|
9 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: EnrollmentPopulation: Only patients with skin biopsies at enrollment are included.
Instrument: Nash dermal fibrosis grade. Measures extent of sclerosis in skin biopsies by histologic examination. Scale ranges from grade 0-5. Nash grade 5 is most severe fibrosis (0 is better outcome, 5 is worse outcome). No subscales are used in Nash grade. Please see table 1 in the reference for grading of dermal fibrosis. Nash RA, McSweeney PA, Crofford LJ, Abidi M, Chen CS, Godwin JD, et al. High-dose immunosuppressive therapy and autologous hematopoietic cell transplantation for severe systemic sclerosis: long-term follow-up of the US multicenter pilot study. Blood 2007;110:1388-96.
Outcome measures
| Measure |
Arm I (Enzyme Inhibitor)
n=32 Participants
Patients who were randomized to receive imatinib mesylate PO QD for 6 months in the absence of progression of sclerosis or unacceptable toxicity.
|
Arm II (Monoclonal Antibody)
n=31 Participants
Patients who were randomized to receive rituximab IV on days 1, 8, 15, and 22. A second treatment cycle was repeated at 3 months for a total of 8 doses of rituximab in the absence of progression of sclerosis or unacceptable toxicity.
|
Imatinib Responders
Attained a SCR with imatinib
|
Imatinib Nonresponders
Did not attain a SCR with imatinib
|
|---|---|---|---|---|
|
Baseline Histopathologic Score in the Two Treatment Arms
|
2 units on a scale
Interval 0.0 to 5.0
|
2 units on a scale
Interval 0.0 to 5.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Only patients who were evaluable at 6mo are included.
Maximum of 10 body areas. Each area can be graded 0 (best) to 4 (worst). Each of those grades requires a percentage of involvement. Improvement is measured by reduction of involvement in any grade and any body area.
Outcome measures
| Measure |
Arm I (Enzyme Inhibitor)
n=30 Participants
Patients who were randomized to receive imatinib mesylate PO QD for 6 months in the absence of progression of sclerosis or unacceptable toxicity.
|
Arm II (Monoclonal Antibody)
n=31 Participants
Patients who were randomized to receive rituximab IV on days 1, 8, 15, and 22. A second treatment cycle was repeated at 3 months for a total of 8 doses of rituximab in the absence of progression of sclerosis or unacceptable toxicity.
|
Imatinib Responders
Attained a SCR with imatinib
|
Imatinib Nonresponders
Did not attain a SCR with imatinib
|
|---|---|---|---|---|
|
Patients With Any Percentage Decline in Any Grade of Sclerosis Without Increase in Percentage of Higher Grades of Sclerosis in Other Areas on the Vienna Skin Scale
|
14 participants
|
9 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 months%CD27+ B cells
Outcome measures
| Measure |
Arm I (Enzyme Inhibitor)
n=3 Participants
Patients who were randomized to receive imatinib mesylate PO QD for 6 months in the absence of progression of sclerosis or unacceptable toxicity.
|
Arm II (Monoclonal Antibody)
n=10 Participants
Patients who were randomized to receive rituximab IV on days 1, 8, 15, and 22. A second treatment cycle was repeated at 3 months for a total of 8 doses of rituximab in the absence of progression of sclerosis or unacceptable toxicity.
|
Imatinib Responders
n=3 Participants
Attained a SCR with imatinib
|
Imatinib Nonresponders
n=11 Participants
Did not attain a SCR with imatinib
|
|---|---|---|---|---|
|
Percentage of CD27+ B Cells in Responders (SCR) and Non-responders
|
10 percentage of CD27+ B cells
Interval 5.0 to 17.0
|
4.3 percentage of CD27+ B cells
Interval 0.0 to 9.0
|
14.2 percentage of CD27+ B cells
Interval 5.2 to 21.6
|
17.1 percentage of CD27+ B cells
Interval 4.8 to 23.7
|
Adverse Events
Imatinib as Initial Therapy
Serious events: 11 serious events
Other events: 12 other events
Deaths: 0 deaths
Rituximab as Initial Therapy
Serious events: 19 serious events
Other events: 12 other events
Deaths: 0 deaths
Imatinib as Secondary Therapy
Serious events: 19 serious events
Other events: 21 other events
Deaths: 0 deaths
Rituximab as Secondary Therapy
Serious events: 15 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Imatinib as Initial Therapy
n=35 participants at risk
Arm I = imatinib, adverse event occurred after the start date of imatinib and if applicable, prior to start date of rituximab.
|
Rituximab as Initial Therapy
n=37 participants at risk
Arm I = rituximab, adverse event occurred after the start date of rituximab and if applicable, prior to start date of imatinib.
|
Imatinib as Secondary Therapy
n=23 participants at risk
Arm II = imatinib, adverse event occurred after the start date of imatinib. (All participants in this group received rituximab prior).
|
Rituximab as Secondary Therapy
n=19 participants at risk
Arm II = rituximab, adverse event occurred after the start date of rituximab. (All participants in this group received imatinib prior).
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/35 • 18 months
|
2.7%
1/37 • Number of events 1 • 18 months
|
0.00%
0/23 • 18 months
|
5.3%
1/19 • Number of events 1 • 18 months
|
|
Blood and lymphatic system disorders
INR increased
|
0.00%
0/35 • 18 months
|
0.00%
0/37 • 18 months
|
0.00%
0/23 • 18 months
|
5.3%
1/19 • Number of events 1 • 18 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.9%
1/35 • Number of events 1 • 18 months
|
5.4%
2/37 • Number of events 2 • 18 months
|
4.3%
1/23 • Number of events 1 • 18 months
|
10.5%
2/19 • Number of events 2 • 18 months
|
|
Cardiac disorders
Aortic valve disease
|
0.00%
0/35 • 18 months
|
2.7%
1/37 • Number of events 1 • 18 months
|
0.00%
0/23 • 18 months
|
0.00%
0/19 • 18 months
|
|
Cardiac disorders
Other, specify: congestive heart failure
|
0.00%
0/35 • 18 months
|
0.00%
0/37 • 18 months
|
0.00%
0/23 • 18 months
|
5.3%
1/19 • Number of events 1 • 18 months
|
|
Cardiac disorders
Other, specify: coronary vasculopathy
|
0.00%
0/35 • 18 months
|
0.00%
0/37 • 18 months
|
4.3%
1/23 • Number of events 1 • 18 months
|
0.00%
0/19 • 18 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/35 • 18 months
|
0.00%
0/37 • 18 months
|
4.3%
1/23 • Number of events 1 • 18 months
|
0.00%
0/19 • 18 months
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/35 • 18 months
|
2.7%
1/37 • Number of events 1 • 18 months
|
0.00%
0/23 • 18 months
|
0.00%
0/19 • 18 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/35 • 18 months
|
2.7%
1/37 • Number of events 1 • 18 months
|
0.00%
0/23 • 18 months
|
0.00%
0/19 • 18 months
|
|
General disorders
Edema limbs
|
2.9%
1/35 • Number of events 1 • 18 months
|
0.00%
0/37 • 18 months
|
0.00%
0/23 • 18 months
|
0.00%
0/19 • 18 months
|
|
General disorders
Fatigue
|
0.00%
0/35 • 18 months
|
2.7%
1/37 • Number of events 1 • 18 months
|
0.00%
0/23 • 18 months
|
0.00%
0/19 • 18 months
|
|
General disorders
Fever
|
0.00%
0/35 • 18 months
|
2.7%
1/37 • Number of events 1 • 18 months
|
4.3%
1/23 • Number of events 1 • 18 months
|
5.3%
1/19 • Number of events 1 • 18 months
|
|
General disorders
Flu like symptoms
|
0.00%
0/35 • 18 months
|
0.00%
0/37 • 18 months
|
0.00%
0/23 • 18 months
|
0.00%
0/19 • 18 months
|
|
General disorders
Other, specify: Pneumoperitoneum
|
0.00%
0/35 • 18 months
|
0.00%
0/37 • 18 months
|
4.3%
1/23 • Number of events 1 • 18 months
|
0.00%
0/19 • 18 months
|
|
Infections and infestations
Lung infection
|
5.7%
2/35 • Number of events 2 • 18 months
|
5.4%
2/37 • Number of events 3 • 18 months
|
17.4%
4/23 • Number of events 4 • 18 months
|
5.3%
1/19 • Number of events 1 • 18 months
|
|
Infections and infestations
Other specify: Norovirus
|
2.9%
1/35 • Number of events 1 • 18 months
|
0.00%
0/37 • 18 months
|
0.00%
0/23 • 18 months
|
0.00%
0/19 • 18 months
|
|
Infections and infestations
Other, specify: unknown etiology
|
0.00%
0/35 • 18 months
|
0.00%
0/37 • 18 months
|
0.00%
0/23 • 18 months
|
5.3%
1/19 • Number of events 2 • 18 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/35 • 18 months
|
0.00%
0/37 • 18 months
|
8.7%
2/23 • Number of events 2 • 18 months
|
0.00%
0/19 • 18 months
|
|
Infections and infestations
Skin infection
|
2.9%
1/35 • Number of events 1 • 18 months
|
0.00%
0/37 • 18 months
|
0.00%
0/23 • 18 months
|
0.00%
0/19 • 18 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/35 • 18 months
|
2.7%
1/37 • Number of events 1 • 18 months
|
0.00%
0/23 • 18 months
|
0.00%
0/19 • 18 months
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/35 • 18 months
|
2.7%
1/37 • Number of events 1 • 18 months
|
0.00%
0/23 • 18 months
|
0.00%
0/19 • 18 months
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/35 • 18 months
|
2.7%
1/37 • Number of events 1 • 18 months
|
0.00%
0/23 • 18 months
|
0.00%
0/19 • 18 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/35 • 18 months
|
2.7%
1/37 • Number of events 1 • 18 months
|
4.3%
1/23 • Number of events 1 • 18 months
|
0.00%
0/19 • 18 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.9%
1/35 • Number of events 1 • 18 months
|
0.00%
0/37 • 18 months
|
0.00%
0/23 • 18 months
|
0.00%
0/19 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Avascular necrosis
|
0.00%
0/35 • 18 months
|
0.00%
0/37 • 18 months
|
0.00%
0/23 • 18 months
|
5.3%
1/19 • Number of events 1 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Other, specify: mastectomy
|
0.00%
0/35 • 18 months
|
0.00%
0/37 • 18 months
|
0.00%
0/23 • 18 months
|
5.3%
1/19 • Number of events 1 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/35 • 18 months
|
0.00%
0/37 • 18 months
|
4.3%
1/23 • Number of events 1 • 18 months
|
0.00%
0/19 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other, specify: brain tumor
|
0.00%
0/35 • 18 months
|
2.7%
1/37 • Number of events 1 • 18 months
|
0.00%
0/23 • 18 months
|
0.00%
0/19 • 18 months
|
|
Renal and urinary disorders
Acute kidney injury
|
2.9%
1/35 • Number of events 1 • 18 months
|
0.00%
0/37 • 18 months
|
0.00%
0/23 • 18 months
|
5.3%
1/19 • Number of events 2 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/35 • 18 months
|
5.4%
2/37 • Number of events 2 • 18 months
|
8.7%
2/23 • Number of events 3 • 18 months
|
0.00%
0/19 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/35 • 18 months
|
0.00%
0/37 • 18 months
|
0.00%
0/23 • 18 months
|
5.3%
1/19 • Number of events 1 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.9%
1/35 • Number of events 1 • 18 months
|
2.7%
1/37 • Number of events 2 • 18 months
|
0.00%
0/23 • 18 months
|
5.3%
1/19 • Number of events 1 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/35 • 18 months
|
0.00%
0/37 • 18 months
|
4.3%
1/23 • Number of events 1 • 18 months
|
0.00%
0/19 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
5.7%
2/35 • Number of events 2 • 18 months
|
0.00%
0/37 • 18 months
|
13.0%
3/23 • Number of events 3 • 18 months
|
0.00%
0/19 • 18 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/35 • 18 months
|
0.00%
0/37 • 18 months
|
0.00%
0/23 • 18 months
|
5.3%
1/19 • Number of events 1 • 18 months
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/35 • 18 months
|
2.7%
1/37 • Number of events 1 • 18 months
|
0.00%
0/23 • 18 months
|
5.3%
1/19 • Number of events 1 • 18 months
|
Other adverse events
| Measure |
Imatinib as Initial Therapy
n=35 participants at risk
Arm I = imatinib, adverse event occurred after the start date of imatinib and if applicable, prior to start date of rituximab.
|
Rituximab as Initial Therapy
n=37 participants at risk
Arm I = rituximab, adverse event occurred after the start date of rituximab and if applicable, prior to start date of imatinib.
|
Imatinib as Secondary Therapy
n=23 participants at risk
Arm II = imatinib, adverse event occurred after the start date of imatinib. (All participants in this group received rituximab prior).
|
Rituximab as Secondary Therapy
n=19 participants at risk
Arm II = rituximab, adverse event occurred after the start date of rituximab. (All participants in this group received imatinib prior).
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.9%
1/35 • Number of events 1 • 18 months
|
0.00%
0/37 • 18 months
|
4.3%
1/23 • Number of events 4 • 18 months
|
5.3%
1/19 • Number of events 1 • 18 months
|
|
General disorders
Infusion related reaction
|
0.00%
0/35 • 18 months
|
2.7%
1/37 • Number of events 1 • 18 months
|
0.00%
0/23 • 18 months
|
0.00%
0/19 • 18 months
|
|
General disorders
Pain
|
0.00%
0/35 • 18 months
|
0.00%
0/37 • 18 months
|
4.3%
1/23 • Number of events 1 • 18 months
|
0.00%
0/19 • 18 months
|
|
Eye disorders
Retinal detachment
|
2.9%
1/35 • Number of events 1 • 18 months
|
0.00%
0/37 • 18 months
|
0.00%
0/23 • 18 months
|
0.00%
0/19 • 18 months
|
|
Gastrointestinal disorders
Nausea
|
2.9%
1/35 • Number of events 1 • 18 months
|
0.00%
0/37 • 18 months
|
0.00%
0/23 • 18 months
|
0.00%
0/19 • 18 months
|
|
Infections and infestations
Lung infection
|
2.9%
1/35 • Number of events 1 • 18 months
|
0.00%
0/37 • 18 months
|
4.3%
1/23 • Number of events 1 • 18 months
|
0.00%
0/19 • 18 months
|
|
Infections and infestations
Skin infection
|
0.00%
0/35 • 18 months
|
2.7%
1/37 • Number of events 1 • 18 months
|
0.00%
0/23 • 18 months
|
0.00%
0/19 • 18 months
|
|
Investigations
Alanine aminotransferase increased
|
2.9%
1/35 • Number of events 1 • 18 months
|
0.00%
0/37 • 18 months
|
0.00%
0/23 • 18 months
|
0.00%
0/19 • 18 months
|
|
Investigations
Aspartate aminotransferase increased
|
2.9%
1/35 • Number of events 1 • 18 months
|
0.00%
0/37 • 18 months
|
0.00%
0/23 • 18 months
|
0.00%
0/19 • 18 months
|
|
Investigations
Creatinine increased
|
2.9%
1/35 • Number of events 1 • 18 months
|
0.00%
0/37 • 18 months
|
4.3%
1/23 • Number of events 1 • 18 months
|
0.00%
0/19 • 18 months
|
|
Investigations
White blood cell decreased
|
2.9%
1/35 • Number of events 1 • 18 months
|
2.7%
1/37 • Number of events 1 • 18 months
|
0.00%
0/23 • 18 months
|
0.00%
0/19 • 18 months
|
|
Investigations
Forced expiratory volume decreased
|
0.00%
0/35 • 18 months
|
2.7%
1/37 • Number of events 1 • 18 months
|
4.3%
1/23 • Number of events 1 • 18 months
|
0.00%
0/19 • 18 months
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/35 • 18 months
|
2.7%
1/37 • Number of events 2 • 18 months
|
4.3%
1/23 • Number of events 1 • 18 months
|
0.00%
0/19 • 18 months
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/35 • 18 months
|
2.7%
1/37 • Number of events 1 • 18 months
|
4.3%
1/23 • Number of events 1 • 18 months
|
0.00%
0/19 • 18 months
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/35 • 18 months
|
0.00%
0/37 • 18 months
|
4.3%
1/23 • Number of events 1 • 18 months
|
0.00%
0/19 • 18 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/35 • 18 months
|
8.1%
3/37 • Number of events 4 • 18 months
|
13.0%
3/23 • Number of events 3 • 18 months
|
0.00%
0/19 • 18 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.7%
2/35 • Number of events 2 • 18 months
|
2.7%
1/37 • Number of events 2 • 18 months
|
4.3%
1/23 • Number of events 1 • 18 months
|
0.00%
0/19 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Avascular necrosis
|
0.00%
0/35 • 18 months
|
0.00%
0/37 • 18 months
|
4.3%
1/23 • Number of events 2 • 18 months
|
0.00%
0/19 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/35 • 18 months
|
0.00%
0/37 • 18 months
|
4.3%
1/23 • Number of events 1 • 18 months
|
0.00%
0/19 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
2.9%
1/35 • Number of events 1 • 18 months
|
0.00%
0/37 • 18 months
|
0.00%
0/23 • 18 months
|
0.00%
0/19 • 18 months
|
|
Reproductive system and breast disorders
Gynecomastia
|
2.9%
1/35 • Number of events 1 • 18 months
|
0.00%
0/37 • 18 months
|
0.00%
0/23 • 18 months
|
0.00%
0/19 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other, specify: squamous cell carcinoma
|
0.00%
0/35 • 18 months
|
0.00%
0/37 • 18 months
|
4.3%
1/23 • Number of events 1 • 18 months
|
0.00%
0/19 • 18 months
|
|
Pregnancy, puerperium and perinatal conditions
Unintended pregnancy
|
0.00%
0/35 • 18 months
|
0.00%
0/37 • 18 months
|
4.3%
1/23 • Number of events 1 • 18 months
|
0.00%
0/19 • 18 months
|
|
Psychiatric disorders
Agitation
|
0.00%
0/35 • 18 months
|
0.00%
0/37 • 18 months
|
4.3%
1/23 • Number of events 1 • 18 months
|
0.00%
0/19 • 18 months
|
|
Renal and urinary disorders
Renal calculi
|
0.00%
0/35 • 18 months
|
0.00%
0/37 • 18 months
|
4.3%
1/23 • Number of events 1 • 18 months
|
0.00%
0/19 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/35 • 18 months
|
0.00%
0/37 • 18 months
|
4.3%
1/23 • Number of events 1 • 18 months
|
0.00%
0/19 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/35 • 18 months
|
0.00%
0/37 • 18 months
|
4.3%
1/23 • Number of events 1 • 18 months
|
0.00%
0/19 • 18 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/35 • 18 months
|
5.4%
2/37 • Number of events 3 • 18 months
|
0.00%
0/23 • 18 months
|
0.00%
0/19 • 18 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/35 • 18 months
|
0.00%
0/37 • 18 months
|
4.3%
1/23 • Number of events 1 • 18 months
|
0.00%
0/19 • 18 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place