Trial Outcomes & Findings for A Study of Dulanermin in Combination With Rituximab in Subjects With Follicular and Other Low Grade, CD20+, Non-Hodgkin's Lymphomas (NCT NCT00400764)
NCT ID: NCT00400764
Last Updated: 2011-11-23
Results Overview
A dose-limiting toxicity (DLT) was defined as a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0 Grade ≥ 3 hematologic or major organ toxicity that was related to study drug (i.e., dulanermin). Although a patient may have experienced a DLT at any time during the study, only events that occurred within the DLT assessment window were considered for dose-escalation decisions and determination of the maximum tolerated dose (MTD).
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
72 participants
Primary outcome timeframe
The DLT assessment window was defined as the duration required to complete two full cycles of treatment with dulanermin (2 * 21 days) and four doses of rituximab (usually through Day 28).
Results posted on
2011-11-23
Participant Flow
The Phase Ib part of this study was completed prior to the start of Phase II. Phase Ib participants were not eligible for participation in Phase II.
Participant milestones
| Measure |
Phase Ib - Dulanermin 4 mg/kg
Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase Ib - Dulanermin 8 mg/kg
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Rituximab
Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Combination Therapy
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Dulanermin
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
|
|---|---|---|---|---|---|
|
Phase Ib
STARTED
|
6
|
6
|
0
|
0
|
0
|
|
Phase Ib
Treated
|
6
|
6
|
0
|
0
|
0
|
|
Phase Ib
COMPLETED
|
0
|
2
|
0
|
0
|
0
|
|
Phase Ib
NOT COMPLETED
|
6
|
4
|
0
|
0
|
0
|
|
Phase II
STARTED
|
0
|
0
|
23
|
26
|
11
|
|
Phase II
Treated
|
0
|
0
|
22
|
26
|
11
|
|
Phase II
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Phase II
NOT COMPLETED
|
0
|
0
|
23
|
26
|
11
|
Reasons for withdrawal
| Measure |
Phase Ib - Dulanermin 4 mg/kg
Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase Ib - Dulanermin 8 mg/kg
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Rituximab
Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Combination Therapy
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Dulanermin
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
|
|---|---|---|---|---|---|
|
Phase Ib
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
|
Phase Ib
Death
|
1
|
0
|
0
|
0
|
0
|
|
Phase Ib
Disease Progression
|
4
|
4
|
0
|
0
|
0
|
|
Phase II
Death
|
0
|
0
|
1
|
2
|
0
|
|
Phase II
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
|
Phase II
Physician Decision
|
0
|
0
|
1
|
1
|
0
|
|
Phase II
Sponsor's decision to terminate
|
0
|
0
|
18
|
22
|
11
|
|
Phase II
Patient began new, non-protocol, therapy
|
0
|
0
|
1
|
0
|
0
|
|
Phase II
Withdrawal by Subject
|
0
|
0
|
1
|
1
|
0
|
Baseline Characteristics
A Study of Dulanermin in Combination With Rituximab in Subjects With Follicular and Other Low Grade, CD20+, Non-Hodgkin's Lymphomas
Baseline characteristics by cohort
| Measure |
Phase Ib - Dulanermin 4 mg/kg
n=6 Participants
Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase Ib - Dulanermin 8 mg/kg
n=6 Participants
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Rituximab
n=22 Participants
Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Combination Therapy
n=26 Participants
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Dulanermin
n=11 Participants
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age Continuous
|
56.3 years
STANDARD_DEVIATION 15.9 • n=5 Participants
|
63.7 years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
NA years
STANDARD_DEVIATION NA • n=5 Participants
|
NA years
STANDARD_DEVIATION NA • n=4 Participants
|
NA years
STANDARD_DEVIATION NA • n=21 Participants
|
60.0 years
STANDARD_DEVIATION 12.9 • n=8 Participants
|
|
Age, Customized
|
NA years
STANDARD_DEVIATION NA • n=5 Participants
|
NA years
STANDARD_DEVIATION NA • n=7 Participants
|
58.0 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
58.4 years
STANDARD_DEVIATION 9.8 • n=4 Participants
|
61.4 years
STANDARD_DEVIATION 13.3 • n=21 Participants
|
58.8 years
STANDARD_DEVIATION 10.0 • n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
51 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: The DLT assessment window was defined as the duration required to complete two full cycles of treatment with dulanermin (2 * 21 days) and four doses of rituximab (usually through Day 28).Population: The DLT-evaluable population consisted of all patients enrolled in the Phase Ib who received at least two complete cycles of dulanermin and four doses of rituximab and complete study assessments through the DLT Assessment Window without a DLT (usually through Day 28) or experienced a DLT and withdrew from the study within the DLT Assessment Window.
A dose-limiting toxicity (DLT) was defined as a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0 Grade ≥ 3 hematologic or major organ toxicity that was related to study drug (i.e., dulanermin). Although a patient may have experienced a DLT at any time during the study, only events that occurred within the DLT assessment window were considered for dose-escalation decisions and determination of the maximum tolerated dose (MTD).
Outcome measures
| Measure |
Phase Ib - Dulanermin 4 mg/kg
n=6 Participants
Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase Ib - Dulanermin 8 mg/kg
n=6 Participants
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Rituximab
Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Combination Therapy
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Dulanermin
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
|
|---|---|---|---|---|---|
|
Phase Ib: Number of Participants With a Dose-limiting Toxicity
|
0 participants
|
0 participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Baseline through Study Termination (up to a maximum of approximately 13 months for phase Ib and up to approximately 33 months for phase II)Population: Safety Evaluable population, consisting of all randomized patients who received at least one dose of treatment.
Safety was assessed through summaries of treatment-emergent adverse events (AEs); AEs were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0, according to the following guidelines: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (Life-threatening or disabling) and Grade 5 (Death related to AE).
Outcome measures
| Measure |
Phase Ib - Dulanermin 4 mg/kg
n=6 Participants
Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase Ib - Dulanermin 8 mg/kg
n=6 Participants
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Rituximab
n=22 Participants
Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Combination Therapy
n=26 Participants
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Dulanermin
n=11 Participants
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events by Severity Grade
Grade 5 AE
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by Severity Grade
Grade 4 AE
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by Severity Grade
Grade 3 AE
|
1 participants
|
3 participants
|
1 participants
|
6 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by Severity Grade
Grade 2 AE
|
4 participants
|
1 participants
|
8 participants
|
10 participants
|
4 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by Severity Grade
Grade 1 AE
|
0 participants
|
2 participants
|
6 participants
|
7 participants
|
4 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events by Severity Grade
Any Grade AEs
|
6 participants
|
6 participants
|
16 participants
|
23 participants
|
8 participants
|
PRIMARY outcome
Timeframe: From Baseline through Study Termination (up to approximately 33 months)Population: The phase II Efficacy-Evaluable population consisted of all randomized patients who received at least one dose of study treatment and had measurable disease at baseline, as assessed by the IRF.
Objective response was defined as a confirmed or unconfirmed complete response (CR, CRu) or partial response (PR) assessed on the basis of clinical, radiographic (computed tomography (CT) scans of the neck, chest, abdomen, pelvis and inguinal region), and pathologic (i.e., bone marrow) criteria and according to the modified International Working Group (IWG) criteria. All radiographic and clinical data for the evaluation of objective response were submitted to an IRF for blinded and impartial assessment. Patients without a post-baseline tumor assessment were considered non-responders.
Outcome measures
| Measure |
Phase Ib - Dulanermin 4 mg/kg
n=22 Participants
Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase Ib - Dulanermin 8 mg/kg
n=25 Participants
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Rituximab
n=11 Participants
Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Combination Therapy
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Dulanermin
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
|
|---|---|---|---|---|---|
|
Phase II: Objective Response as Assessed by the Independent Review Facility (IRF)
Total Objective Response
|
14 participants
|
16 participants
|
1 participants
|
—
|
—
|
|
Phase II: Objective Response as Assessed by the Independent Review Facility (IRF)
Complete Response
|
5 participants
|
3 participants
|
0 participants
|
—
|
—
|
|
Phase II: Objective Response as Assessed by the Independent Review Facility (IRF)
Complete Response unconfirmed
|
0 participants
|
2 participants
|
0 participants
|
—
|
—
|
|
Phase II: Objective Response as Assessed by the Independent Review Facility (IRF)
Partial Response
|
9 participants
|
11 participants
|
1 participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and Treatment Termination visit (8 weeks for Rituximab arm and 12 weeks for combination and Dulanermin arms)Population: Safety Evaluable population, consisting of all randomized patients who received at least one dose of treatment.
Blood pressure was measured at baseline and throughout the study. Change from baseline was calculated using the patient's last recorded measurement at the completion of treatment visit - baseline measurement.
Outcome measures
| Measure |
Phase Ib - Dulanermin 4 mg/kg
n=6 Participants
Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase Ib - Dulanermin 8 mg/kg
n=6 Participants
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Rituximab
n=22 Participants
Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Combination Therapy
n=26 Participants
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Dulanermin
n=11 Participants
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
|
|---|---|---|---|---|---|
|
Vital Signs: Change From Baseline in Diastolic and Systolic Blood Pressure at Treatment Termination Visit
Diastolic Blood Pressure
|
-8.7 mmHg
Standard Deviation 10.9
|
-5.2 mmHg
Standard Deviation 7.9
|
2.3 mmHg
Standard Deviation 9.9
|
1.6 mmHg
Standard Deviation 9.2
|
-0.8 mmHg
Standard Deviation 5.6
|
|
Vital Signs: Change From Baseline in Diastolic and Systolic Blood Pressure at Treatment Termination Visit
Systolic Blood Pressure
|
-3.2 mmHg
Standard Deviation 16.8
|
-4.7 mmHg
Standard Deviation 10.9
|
-3.4 mmHg
Standard Deviation 14.8
|
-2.2 mmHg
Standard Deviation 19.6
|
-4.2 mmHg
Standard Deviation 9.5
|
PRIMARY outcome
Timeframe: Baseline and Treatment Termination visit (8 weeks for Rituximab arm and 12 weeks for combination and Dulanermin arms)Population: Safety Evaluable population, consisting of all randomized patients who received at least one dose of treatment.
Heart rate was measured at baseline and throughout the study. Change from baseline was calculated using the patient's last recorded measurement at the completion of treatment visit - baseline measurement.
Outcome measures
| Measure |
Phase Ib - Dulanermin 4 mg/kg
n=6 Participants
Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase Ib - Dulanermin 8 mg/kg
n=6 Participants
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Rituximab
n=22 Participants
Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Combination Therapy
n=26 Participants
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Dulanermin
n=11 Participants
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
|
|---|---|---|---|---|---|
|
Vital Signs: Change From Baseline in Heart Rate at Treatment Termination Visit
|
7.0 beats/minute
Standard Deviation 21.4
|
-1.5 beats/minute
Standard Deviation 6.7
|
0.5 beats/minute
Standard Deviation 9.6
|
3.3 beats/minute
Standard Deviation 10.6
|
5.0 beats/minute
Standard Deviation 13.2
|
PRIMARY outcome
Timeframe: Baseline and Treatment Termination visit (8 weeks for Rituximab arm and 12 weeks for combination and Dulanermin arms)Population: Safety Evaluable population, consisting of all randomized patients who received at least one dose of treatment.
Body temperature was measured at baseline and throughout the study. Change from baseline was calculated using the patients last recorded measurement at the completion of treatment visit - baseline measurement.
Outcome measures
| Measure |
Phase Ib - Dulanermin 4 mg/kg
n=6 Participants
Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase Ib - Dulanermin 8 mg/kg
n=6 Participants
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Rituximab
n=22 Participants
Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Combination Therapy
n=26 Participants
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Dulanermin
n=11 Participants
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
|
|---|---|---|---|---|---|
|
Vital Signs: Change From Baseline in Body Temperature at Treatment Termination Visit
|
-0.0 degrees Celsius
Standard Deviation 0.6
|
-0.3 degrees Celsius
Standard Deviation 0.7
|
2.8 degrees Celsius
Standard Deviation 13.1
|
-0.1 degrees Celsius
Standard Deviation 0.4
|
0.0 degrees Celsius
Standard Deviation 0.4
|
PRIMARY outcome
Timeframe: Baseline and Treatment Termination visit (8 weeks for Rituximab arm and 12 weeks for combination and Dulanermin arms).Population: Safety Evaluable population consisting of all randomized patients who received at least one dose of study drug.
Laboratory Parameters were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE). A clinically significant abnormality was defined as a Grade 3 (severe) or Grade 4 (very severe, life threatening, or disabling) laboratory toxicity according to the NCI CTCAE v3.0.
Outcome measures
| Measure |
Phase Ib - Dulanermin 4 mg/kg
n=6 Participants
Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase Ib - Dulanermin 8 mg/kg
n=6 Participants
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Rituximab
n=22 Participants
Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Combination Therapy
n=26 Participants
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Dulanermin
n=11 Participants
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
|
|---|---|---|---|---|---|
|
Number of Participants With a Clinically Significant Laboratory Abnormality
|
3 participants
|
4 participants
|
5 participants
|
11 participants
|
5 participants
|
PRIMARY outcome
Timeframe: Blood samples were taken 0.5, 1.5, 2, 3, 5, 7 and 24 hours after the start of the infusion on Day 1 of Cycle 1.Population: Safety-evaluable population
The dulanermin serum concentration was measured using enzyme linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Phase Ib - Dulanermin 4 mg/kg
n=12 Participants
Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase Ib - Dulanermin 8 mg/kg
n=43 Participants
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Rituximab
Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Combination Therapy
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Dulanermin
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
|
|---|---|---|---|---|---|
|
Mean Serum Concentration of Dulanermin
30 minutes after the start of infusion
|
0.109 µg/ml
Standard Deviation 0.37
|
0.001 µg/ml
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Mean Serum Concentration of Dulanermin
1.5 hours after the start of infusion
|
40.4 µg/ml
Standard Deviation 19.03
|
51.5 µg/ml
Standard Deviation 14.00
|
—
|
—
|
—
|
|
Mean Serum Concentration of Dulanermin
3 hours after the start of infusion
|
29.5 µg/ml
Standard Deviation 20.75
|
28.7 µg/ml
Standard Deviation 10.13
|
—
|
—
|
—
|
|
Mean Serum Concentration of Dulanermin
5 hours after the start of infusion
|
2.21 µg/ml
Standard Deviation 1.87
|
9.89 µg/ml
Standard Deviation 21.86
|
—
|
—
|
—
|
|
Mean Serum Concentration of Dulanermin
7 hours after the start of infusion
|
4.89 µg/ml
Standard Deviation 15.69
|
0.445 µg/ml
Standard Deviation 0.26
|
—
|
—
|
—
|
|
Mean Serum Concentration of Dulanermin
24 hours after the start of infusion
|
0.324 µg/ml
Standard Deviation 0.66
|
0.002 µg/ml
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Mean Serum Concentration of Dulanermin
2 hours after the start of infusion
|
49.9 µg/ml
Standard Deviation 32.04
|
79.8 µg/ml
Standard Deviation 22.54
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline through Study Termination (up to approximately 33 months)Population: Safety-Evaluable population consisting of all randomized patients who received at least one dose of study treatment
Progression free survival (PFS) was defined as the time from randomization to documented disease progression or death, whichever occurred first and was based on the investigator's assessment using the modified IWG criteria. Kaplan-Meier methods were used to estimate median time to PFS. Data for patients without disease progression or death on study were censored at the time of the last tumor assessment.
Outcome measures
| Measure |
Phase Ib - Dulanermin 4 mg/kg
n=22 Participants
Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase Ib - Dulanermin 8 mg/kg
n=26 Participants
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Rituximab
n=11 Participants
Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Combination Therapy
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Dulanermin
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
|
|---|---|---|---|---|---|
|
Phase II: Progression Free Survival
|
29.9 months
Interval 9.2 to 29.9
|
17.9 months
Interval 9.9 to 18.4
|
6.9 months
Interval 2.9 to
The upper limit of the confidence interval was not estimable due to low numbers of events.
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline through Study Termination (up to approximately 33 months)Median overall survival could not be estimated because of the low number of deaths at the time of study termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Baseline through Study Termination (up to approximately 33 months)Population: Safety Evaluable population, consisting of all randomized patients who received at least one dose of treatment.
Objective response was defined as a confirmed or unconfirmed complete response(CR, CRu) or partial response (PR) assessed on the basis of clinical, radiographic (computed tomography (CT) scans of the neck, chest, abdomen, pelvis and inguinal region), and pathologic (i.e., bone marrow) criteria and according to the modified International Working Group (IWG) criteria. Patients without a post-baseline tumor assessment were considered non-responders.
Outcome measures
| Measure |
Phase Ib - Dulanermin 4 mg/kg
n=22 Participants
Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase Ib - Dulanermin 8 mg/kg
n=26 Participants
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Rituximab
n=11 Participants
Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Combination Therapy
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Dulanermin
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
|
|---|---|---|---|---|---|
|
Phase II: Objective Response as Assessed by the Investigator
Total Objective Response
|
15 participants
|
17 participants
|
1 participants
|
—
|
—
|
|
Phase II: Objective Response as Assessed by the Investigator
Complete Response
|
7 participants
|
7 participants
|
1 participants
|
—
|
—
|
|
Phase II: Objective Response as Assessed by the Investigator
Complete Response unconfirmed
|
0 participants
|
1 participants
|
0 participants
|
—
|
—
|
|
Phase II: Objective Response as Assessed by the Investigator
Partial Response
|
8 participants
|
9 participants
|
0 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline through Study Termination (up to approximately 33 months)Population: Safety-evaluable patients with an objective response determined by the Investigator.
An event was defined as documented disease progression or death on study, whichever occurred first. Duration of objective response was defined only for patients with an objective response as determined by the investigator and was the time from the initial response to disease progression or death on study. Kaplan-Meier methods were used to estimate median, percentiles, and range of duration of response.
Outcome measures
| Measure |
Phase Ib - Dulanermin 4 mg/kg
n=15 Participants
Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase Ib - Dulanermin 8 mg/kg
n=17 Participants
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Rituximab
n=1 Participants
Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Combination Therapy
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Dulanermin
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
|
|---|---|---|---|---|---|
|
Phase II: Duration of Response as Assessed by the Investigator
|
21.4 months
Interval 7.7 to 21.4
|
11.3 months
Interval 8.0 to
Could not be calculated due to low number of patients with events.
|
NA months
Median duration of objective response could not be estimated for the dulanermin only arm because only 1 patient had an objective response based on investigator assessment
|
—
|
—
|
Adverse Events
Phase Ib - Dulanermin 4 mg/kg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase Ib - Dulanermin 8 mg/kg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase II - Rituximab
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Phase II - Combination Therapy
Serious events: 4 serious events
Other events: 22 other events
Deaths: 0 deaths
Phase II - Dulanermin
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase Ib - Dulanermin 4 mg/kg
n=6 participants at risk
Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase Ib - Dulanermin 8 mg/kg
n=6 participants at risk
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Rituximab
n=22 participants at risk
Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Combination Therapy
n=26 participants at risk
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Dulanermin
n=11 participants at risk
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
3.8%
1/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
3.8%
1/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
General disorders
INFUSION RELATED REACTION
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
3.8%
1/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
3.8%
1/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MYELODYSPLASTIC SYNDROME
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
4.5%
1/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Gastrointestinal disorders
ILEUS PARALYTIC
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Infections and infestations
SEPSIS
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
Other adverse events
| Measure |
Phase Ib - Dulanermin 4 mg/kg
n=6 participants at risk
Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase Ib - Dulanermin 8 mg/kg
n=6 participants at risk
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Rituximab
n=22 participants at risk
Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Combination Therapy
n=26 participants at risk
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses.
|
Phase II - Dulanermin
n=11 participants at risk
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
33.3%
2/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
33.3%
2/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
9.1%
2/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
7.7%
2/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Gastrointestinal disorders
NAUSEA
|
33.3%
2/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
33.3%
2/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
18.2%
4/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
15.4%
4/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Gastrointestinal disorders
VOMITING
|
33.3%
2/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
13.6%
3/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
11.5%
3/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
33.3%
2/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
3.8%
1/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
33.3%
2/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
4.5%
1/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
15.4%
4/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Gastrointestinal disorders
ORAL PAIN
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Gastrointestinal disorders
SENSITIVITY OF TEETH
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Gastrointestinal disorders
STOMATITIS
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Gastrointestinal disorders
TOOTHACHE
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
9.1%
2/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
7.7%
2/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
9.1%
1/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
General disorders
FATIGUE
|
100.0%
6/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
50.0%
3/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
9.1%
2/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
11.5%
3/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
27.3%
3/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
General disorders
CHILLS
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
50.0%
3/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
General disorders
PYREXIA
|
33.3%
2/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
19.2%
5/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
General disorders
CATHETER SITE PAIN
|
33.3%
2/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
General disorders
CHEST PAIN
|
33.3%
2/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
4.5%
1/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
3.8%
1/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
General disorders
CATHETER SITE ERYTHEMA
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
General disorders
CATHETER SITE PRURITUS
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
General disorders
FEELING COLD
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
General disorders
GAIT DISTURBANCE
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
General disorders
MUCOSAL INFLAMMATION
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
General disorders
OEDEMA PERIPHERAL
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
3.8%
1/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
General disorders
PAIN
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
4.5%
1/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
3.8%
1/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
General disorders
SWELLING
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
General disorders
ASTHENIA
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
15.4%
4/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
18.2%
2/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
General disorders
HERNIA
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
9.1%
1/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Skin and subcutaneous tissue disorders
RASH
|
33.3%
2/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
50.0%
3/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
9.1%
2/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Skin and subcutaneous tissue disorders
NIGHT SWEATS
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
33.3%
2/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
9.1%
2/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Skin and subcutaneous tissue disorders
EXFOLIATIVE RASH
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Skin and subcutaneous tissue disorders
SKIN INDURATION
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
50.0%
3/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
9.1%
2/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Metabolism and nutrition disorders
METABOLIC ACIDOSIS
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Metabolism and nutrition disorders
FLUID RETENTION
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
9.1%
1/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Nervous system disorders
HEADACHE
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
4.5%
1/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
15.4%
4/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Nervous system disorders
PARAESTHESIA
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
33.3%
2/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Nervous system disorders
SINUS HEADACHE
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
33.3%
2/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Nervous system disorders
TREMOR
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
4.5%
1/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
9.1%
1/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Nervous system disorders
DYSGEUSIA
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Nervous system disorders
HYPOGEUSIA
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
7.7%
2/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
33.3%
2/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
13.6%
3/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
3.8%
1/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
13.6%
3/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
7.7%
2/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Respiratory, thoracic and mediastinal disorders
SINUS CONGESTION
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
7.7%
2/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
9.1%
1/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Respiratory, thoracic and mediastinal disorders
LUNG CONSOLIDATION
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
4.5%
1/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
3.8%
1/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISTRESS
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY TRACT CONGESTION
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
9.1%
2/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
50.0%
3/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
18.2%
4/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
7.7%
2/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
3.8%
1/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
33.3%
2/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Infections and infestations
GROIN INFECTION
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Infections and infestations
HERPES ZOSTER
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
4.5%
1/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Infections and infestations
PNEUMONIA
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Infections and infestations
ORAL HERPES
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
4.5%
1/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
15.4%
4/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Infections and infestations
VIRAL INFECTION
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
18.2%
2/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Infections and infestations
RHINITIS
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
9.1%
1/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Investigations
LIPASE INCREASED
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Investigations
BACTERIAL TEST POSITIVE
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Investigations
BLOOD AMYLASE INCREASED
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Vascular disorders
HYPOTENSION
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Vascular disorders
PHLEBITIS SUPERFICIAL
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
4.5%
1/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
3.8%
1/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
9.1%
1/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Vascular disorders
PHLEBITIS
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
7.7%
2/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
4.5%
1/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Psychiatric disorders
INSOMNIA
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
4.5%
1/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Psychiatric disorders
NERVOUSNESS
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
4.5%
1/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Renal and urinary disorders
NOCTURIA
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
4.5%
1/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Blood and lymphatic system disorders
COAGULOPATHY
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Blood and lymphatic system disorders
DISSEMINATED INTRAVASCULAR COAGULATION
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
4.5%
1/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Cardiac disorders
LEFT VENTRICULAR DYSFUNCTION
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Cardiac disorders
RIGHT VENTRICULAR DYSFUNCTION
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Ear and labyrinth disorders
DEAFNESS UNILATERAL
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Endocrine disorders
ADRENAL INSUFFICIENCY
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Eye disorders
DRY EYE
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Eye disorders
VISION BLURRED
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
3.8%
1/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
9.1%
1/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
4.5%
1/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Injury, poisoning and procedural complications
INCISION SITE PAIN
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
16.7%
1/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/6 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/22 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
7.7%
2/26 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
0.00%
0/11 • Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Evaluation is on all Treated Patients.
|
Additional Information
Medical Communications
Hoffman-LaRoche
Phone: 800-821-8590
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER