Trial Outcomes & Findings for A Randomized Trial of a Combination of Nintedanib/Placebo in Combination With Induction Chemotherapy for Patients With Refractory or First Relapse Acute Myeloid Leukemia (NCT NCT02665143)
NCT ID: NCT02665143
Last Updated: 2022-04-08
Results Overview
In the Phase 1 portion of the study, safety will be assessed after the inclusion of the first 6 patients, to analyze tolerance and adverse events occurring during this trial and will decide on any action to be taken. Safety will be evaluated according to NCI CTCAE V4 criteria. TEAE's were considered adverse events that occurred within 60 days of treatment initiation. The title of this outcome measure was adjusted when results were entered.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
60 days
Results posted on
2022-04-08
Participant Flow
Participant milestones
| Measure |
Nintedanib and AML Induction
The AML induction regimen combines Idarubicin 12mg/m2/d day 1 to 3 and Cytarabine 0.667g/m2/d CIV day 1 to 3. Based on the phase I dose, in the randomized phase II, the combination will be compared with chemotherapy+placebo. Nintedanib or placebo will be added at day 8 and continued until end of cycle .
Nintedanib and AML induction: The AML induction regimen combines Idarubicin 12mg/m2/d day 1 to 3 and Cytarabine 0.667g/m2/d CIV day 1 to 3. In the phase I part, all patients will receive the combination with Nintedanib 200mg bid begun at day 8 and continued until end of cycle. If a significant incidence of dose limiting toxicities is demonstrated, Nintedanib will be given at a lower dose level (150mg bid).
|
|---|---|
|
Phase 1
STARTED
|
6
|
|
Phase 1
COMPLETED
|
6
|
|
Phase 1
NOT COMPLETED
|
0
|
|
Phase 2
STARTED
|
19
|
|
Phase 2
Completed 0 Cycles
|
1
|
|
Phase 2
Completed 1 Cycle
|
12
|
|
Phase 2
Completed 2 Cycles
|
3
|
|
Phase 2
Completed 3 Cycles
|
3
|
|
Phase 2
COMPLETED
|
19
|
|
Phase 2
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
There were 6 Phase 1 patients and 19 Phase 2 patients.
Baseline characteristics by cohort
| Measure |
Nintedanib and AML Induction
n=25 Participants
The AML induction regimen combines Idarubicin 12mg/m2/d day 1 to 3 and Cytarabine 0.667g/m2/d CIV day 1 to 3. Based on the phase I dose, in the randomized phase II, the combination will be compared with chemotherapy+placebo. Nintedanib or placebo will be added at day 8 and continued until end of cycle .
Nintedanib and AML induction: The AML induction regimen combines Idarubicin 12mg/m2/d day 1 to 3 and Cytarabine 0.667g/m2/d CIV day 1 to 3. In the phase I part, all patients will receive the combination with Nintedanib 200mg bid begun at day 8 and continued until end of cycle. If a significant incidence of dose limiting toxicities is demonstrated, Nintedanib will be given at a lower dose level (150mg bid).
|
|---|---|
|
Age, Categorical
Phase 1 · <=18 years
|
0 Participants
n=6 Participants • There were 6 Phase 1 patients and 19 Phase 2 patients.
|
|
Age, Categorical
Phase 1 · Between 18 and 65 years
|
4 Participants
n=6 Participants • There were 6 Phase 1 patients and 19 Phase 2 patients.
|
|
Age, Categorical
Phase 1 · >=65 years
|
2 Participants
n=6 Participants • There were 6 Phase 1 patients and 19 Phase 2 patients.
|
|
Age, Categorical
Phase 2 · <=18 years
|
0 Participants
n=19 Participants • There were 6 Phase 1 patients and 19 Phase 2 patients.
|
|
Age, Categorical
Phase 2 · Between 18 and 65 years
|
16 Participants
n=19 Participants • There were 6 Phase 1 patients and 19 Phase 2 patients.
|
|
Age, Categorical
Phase 2 · >=65 years
|
3 Participants
n=19 Participants • There were 6 Phase 1 patients and 19 Phase 2 patients.
|
|
Sex: Female, Male
Phase 1 · Female
|
2 Participants
n=6 Participants • There were 6 Phase 1 patients and 19 Phase 2 patients.
|
|
Sex: Female, Male
Phase 1 · Male
|
4 Participants
n=6 Participants • There were 6 Phase 1 patients and 19 Phase 2 patients.
|
|
Sex: Female, Male
Phase 2 · Female
|
9 Participants
n=19 Participants • There were 6 Phase 1 patients and 19 Phase 2 patients.
|
|
Sex: Female, Male
Phase 2 · Male
|
10 Participants
n=19 Participants • There were 6 Phase 1 patients and 19 Phase 2 patients.
|
|
Ethnicity (NIH/OMB)
Phase 1 · Hispanic or Latino
|
0 Participants
n=6 Participants • There were 6 Phase 1 patients and 19 Phase 2 patients.
|
|
Ethnicity (NIH/OMB)
Phase 1 · Not Hispanic or Latino
|
6 Participants
n=6 Participants • There were 6 Phase 1 patients and 19 Phase 2 patients.
|
|
Ethnicity (NIH/OMB)
Phase 1 · Unknown or Not Reported
|
0 Participants
n=6 Participants • There were 6 Phase 1 patients and 19 Phase 2 patients.
|
|
Ethnicity (NIH/OMB)
Phase 2 · Hispanic or Latino
|
2 Participants
n=19 Participants • There were 6 Phase 1 patients and 19 Phase 2 patients.
|
|
Ethnicity (NIH/OMB)
Phase 2 · Not Hispanic or Latino
|
15 Participants
n=19 Participants • There were 6 Phase 1 patients and 19 Phase 2 patients.
|
|
Ethnicity (NIH/OMB)
Phase 2 · Unknown or Not Reported
|
2 Participants
n=19 Participants • There were 6 Phase 1 patients and 19 Phase 2 patients.
|
|
Race (NIH/OMB)
Phase 1 · American Indian or Alaska Native
|
0 Participants
n=6 Participants • There were 6 Phase 1 patients and 19 Phase 2 patients.
|
|
Race (NIH/OMB)
Phase 1 · Asian
|
0 Participants
n=6 Participants • There were 6 Phase 1 patients and 19 Phase 2 patients.
|
|
Race (NIH/OMB)
Phase 1 · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6 Participants • There were 6 Phase 1 patients and 19 Phase 2 patients.
|
|
Race (NIH/OMB)
Phase 1 · Black or African American
|
0 Participants
n=6 Participants • There were 6 Phase 1 patients and 19 Phase 2 patients.
|
|
Race (NIH/OMB)
Phase 1 · White
|
6 Participants
n=6 Participants • There were 6 Phase 1 patients and 19 Phase 2 patients.
|
|
Race (NIH/OMB)
Phase 1 · More than one race
|
0 Participants
n=6 Participants • There were 6 Phase 1 patients and 19 Phase 2 patients.
|
|
Race (NIH/OMB)
Phase 1 · Unknown or Not Reported
|
0 Participants
n=6 Participants • There were 6 Phase 1 patients and 19 Phase 2 patients.
|
|
Race (NIH/OMB)
Phase 2 · American Indian or Alaska Native
|
0 Participants
n=19 Participants • There were 6 Phase 1 patients and 19 Phase 2 patients.
|
|
Race (NIH/OMB)
Phase 2 · Asian
|
1 Participants
n=19 Participants • There were 6 Phase 1 patients and 19 Phase 2 patients.
|
|
Race (NIH/OMB)
Phase 2 · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=19 Participants • There were 6 Phase 1 patients and 19 Phase 2 patients.
|
|
Race (NIH/OMB)
Phase 2 · Black or African American
|
1 Participants
n=19 Participants • There were 6 Phase 1 patients and 19 Phase 2 patients.
|
|
Race (NIH/OMB)
Phase 2 · White
|
13 Participants
n=19 Participants • There were 6 Phase 1 patients and 19 Phase 2 patients.
|
|
Race (NIH/OMB)
Phase 2 · More than one race
|
0 Participants
n=19 Participants • There were 6 Phase 1 patients and 19 Phase 2 patients.
|
|
Race (NIH/OMB)
Phase 2 · Unknown or Not Reported
|
4 Participants
n=19 Participants • There were 6 Phase 1 patients and 19 Phase 2 patients.
|
|
Region of Enrollment
United States
|
25 participants
n=25 Participants
|
PRIMARY outcome
Timeframe: 60 daysPopulation: Phase 1 patients.
In the Phase 1 portion of the study, safety will be assessed after the inclusion of the first 6 patients, to analyze tolerance and adverse events occurring during this trial and will decide on any action to be taken. Safety will be evaluated according to NCI CTCAE V4 criteria. TEAE's were considered adverse events that occurred within 60 days of treatment initiation. The title of this outcome measure was adjusted when results were entered.
Outcome measures
| Measure |
Nintedanib and AML Induction
n=6 Participants
The AML induction regimen combines Idarubicin 12mg/m2/d day 1 to 3 and Cytarabine 0.667g/m2/d CIV day 1 to 3. Based on the phase I dose, in the randomized phase II, the combination will be compared with chemotherapy+placebo. Nintedanib or placebo will be added at day 8 and continued until end of cycle .
Nintedanib and AML induction: The AML induction regimen combines Idarubicin 12mg/m2/d day 1 to 3 and Cytarabine 0.667g/m2/d CIV day 1 to 3. In the phase I part, all patients will receive the combination with Nintedanib 200mg bid begun at day 8 and continued until end of cycle. If a significant incidence of dose limiting toxicities is demonstrated, Nintedanib will be given at a lower dose level (150mg bid).
|
|---|---|
|
Count of Patients With Treatment-Emergent Adverse Events (Phase 1)
|
6 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsIn Phase 2, the primary endpoint of complete remission rate will be based on IWG 2003 AML response criteria. This construct is an overall response composite and it will be assessed using the following metrics: Morphologic complete remission (CR): ANC ≥ 1,000/mcl, platelet count ≥ 100,000/mcl, \< 5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease. (No requirements for marrow cellularity, hemoglobin concentration). Morphologic complete remission with incomplete blood count recovery (CRi): Same as CR but ANC may be \< 1,000/mcl but \>500 mcl and/or platelet count \< 100,000/mcl but \>20,000/mcl Partial remission (PR): ANC ≥ 1,000/mcl, platelet count \> 100,000/mcl, and at least a 50% decrease in the percentage of marrow aspirate blasts to 5-25%, or marrow blasts \< 5% with persistent Auer rods. Marrow Leukemia Free State: \< 5% bone marrow blasts, no Auer rods, no extra medullary disease. No requirement on cytopenias.
Outcome measures
| Measure |
Nintedanib and AML Induction
n=19 Participants
The AML induction regimen combines Idarubicin 12mg/m2/d day 1 to 3 and Cytarabine 0.667g/m2/d CIV day 1 to 3. Based on the phase I dose, in the randomized phase II, the combination will be compared with chemotherapy+placebo. Nintedanib or placebo will be added at day 8 and continued until end of cycle .
Nintedanib and AML induction: The AML induction regimen combines Idarubicin 12mg/m2/d day 1 to 3 and Cytarabine 0.667g/m2/d CIV day 1 to 3. In the phase I part, all patients will receive the combination with Nintedanib 200mg bid begun at day 8 and continued until end of cycle. If a significant incidence of dose limiting toxicities is demonstrated, Nintedanib will be given at a lower dose level (150mg bid).
|
|---|---|
|
Complete Remission Rate (Phase 2)
Complete Remission
|
5 Participants
|
|
Complete Remission Rate (Phase 2)
Complete Remission with incomplete counts recovery
|
4 Participants
|
|
Complete Remission Rate (Phase 2)
Non-evaluable
|
1 Participants
|
|
Complete Remission Rate (Phase 2)
Partial Remission
|
1 Participants
|
|
Complete Remission Rate (Phase 2)
Stable Disease
|
7 Participants
|
|
Complete Remission Rate (Phase 2)
Progressive Disease
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsEvaluation of hematological improvement will be assessed based on IWG MDS 2006 criteria. Due to differing pretreatment conditions of participants, response to treatment in this construct will be assessed in the following manner: Erythroid response (pretreatment \<11 g/dL) : Hgb increase at least by 1.5 g/dL. Relevant reduction of units of RBC transfusions by an absolute number of at least 4 RBC transfusions/8 wk compared with the pretreatment transfusion number in the previous 8 wk. Only RBC transfusions given for a Hgb of below or equal to 9.0 g/dL pretreatment will count in the RBC transfusion response evaluation. Platelet response (pretreatment 100x109/L): Absolute increase of at least 30x109/L for patients starting with more than 20x109/L platelets. Increase from less than 20x109/L to more than 20x109/L and by at least 100%. Neutrophil response (pretreatment, \<1.0x109/L) At least 100% increase and an absolute increase of at least 0.5x109/L.
Outcome measures
| Measure |
Nintedanib and AML Induction
n=19 Participants
The AML induction regimen combines Idarubicin 12mg/m2/d day 1 to 3 and Cytarabine 0.667g/m2/d CIV day 1 to 3. Based on the phase I dose, in the randomized phase II, the combination will be compared with chemotherapy+placebo. Nintedanib or placebo will be added at day 8 and continued until end of cycle .
Nintedanib and AML induction: The AML induction regimen combines Idarubicin 12mg/m2/d day 1 to 3 and Cytarabine 0.667g/m2/d CIV day 1 to 3. In the phase I part, all patients will receive the combination with Nintedanib 200mg bid begun at day 8 and continued until end of cycle. If a significant incidence of dose limiting toxicities is demonstrated, Nintedanib will be given at a lower dose level (150mg bid).
|
|---|---|
|
Incidence of Hematological Improvement (Phase 2)
Hematological Improvement Erythroid · Yes
|
3 Participants
|
|
Incidence of Hematological Improvement (Phase 2)
Hematological Improvement Erythroid · No
|
13 Participants
|
|
Incidence of Hematological Improvement (Phase 2)
Hematological Improvement Erythroid · Missing
|
3 Participants
|
|
Incidence of Hematological Improvement (Phase 2)
Hematological Improvement Neutrophils · Yes
|
6 Participants
|
|
Incidence of Hematological Improvement (Phase 2)
Hematological Improvement Neutrophils · No
|
10 Participants
|
|
Incidence of Hematological Improvement (Phase 2)
Hematological Improvement Neutrophils · Missing
|
3 Participants
|
|
Incidence of Hematological Improvement (Phase 2)
Hematological Improvement Platelet · Yes
|
6 Participants
|
|
Incidence of Hematological Improvement (Phase 2)
Hematological Improvement Platelet · No
|
10 Participants
|
|
Incidence of Hematological Improvement (Phase 2)
Hematological Improvement Platelet · Missing
|
3 Participants
|
Adverse Events
Nintedanib and AML Induction: Phase 1
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Nintedanib and AML Induction: Phase 2
Serious events: 8 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nintedanib and AML Induction: Phase 1
n=6 participants at risk
The AML induction regimen combines Idarubicin 12mg/m2/d day 1 to 3 and Cytarabine 0.667g/m2/d CIV day 1 to 3. Based on the phase I dose, in the randomized phase II, the combination will be compared with chemotherapy+placebo. Nintedanib or placebo will be added at day 8 and continued until end of cycle .
Nintedanib and AML induction: The AML induction regimen combines Idarubicin 12mg/m2/d day 1 to 3 and Cytarabine 0.667g/m2/d CIV day 1 to 3. In the phase I part, all patients will receive the combination with Nintedanib 200mg bid begun at day 8 and continued until end of cycle. If a significant incidence of dose limiting toxicities is demonstrated, Nintedanib will be given at a lower dose level (150mg bid).
|
Nintedanib and AML Induction: Phase 2
n=19 participants at risk
The AML induction regimen combines Idarubicin 12mg/m2/d day 1 to 3 and Cytarabine 0.667g/m2/d CIV day 1 to 3. Based on the phase I dose, in the randomized phase II, the combination will be compared with chemotherapy+placebo. Nintedanib or placebo will be added at day 8 and continued until end of cycle .
Nintedanib and AML induction: The AML induction regimen combines Idarubicin 12mg/m2/d day 1 to 3 and Cytarabine 0.667g/m2/d CIV day 1 to 3. In the phase I part, all patients will receive the combination with Nintedanib 200mg bid begun at day 8 and continued until end of cycle. If a significant incidence of dose limiting toxicities is demonstrated, Nintedanib will be given at a lower dose level (150mg bid).
|
|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 3 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Vascular disorders
Thromboembolic event
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
0.00%
0/19 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
31.6%
6/19 • Number of events 8 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Cardiac disorders
Heart failure
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Infections and infestations
Infections and infestations - Other
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 2 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
Other adverse events
| Measure |
Nintedanib and AML Induction: Phase 1
n=6 participants at risk
The AML induction regimen combines Idarubicin 12mg/m2/d day 1 to 3 and Cytarabine 0.667g/m2/d CIV day 1 to 3. Based on the phase I dose, in the randomized phase II, the combination will be compared with chemotherapy+placebo. Nintedanib or placebo will be added at day 8 and continued until end of cycle .
Nintedanib and AML induction: The AML induction regimen combines Idarubicin 12mg/m2/d day 1 to 3 and Cytarabine 0.667g/m2/d CIV day 1 to 3. In the phase I part, all patients will receive the combination with Nintedanib 200mg bid begun at day 8 and continued until end of cycle. If a significant incidence of dose limiting toxicities is demonstrated, Nintedanib will be given at a lower dose level (150mg bid).
|
Nintedanib and AML Induction: Phase 2
n=19 participants at risk
The AML induction regimen combines Idarubicin 12mg/m2/d day 1 to 3 and Cytarabine 0.667g/m2/d CIV day 1 to 3. Based on the phase I dose, in the randomized phase II, the combination will be compared with chemotherapy+placebo. Nintedanib or placebo will be added at day 8 and continued until end of cycle .
Nintedanib and AML induction: The AML induction regimen combines Idarubicin 12mg/m2/d day 1 to 3 and Cytarabine 0.667g/m2/d CIV day 1 to 3. In the phase I part, all patients will receive the combination with Nintedanib 200mg bid begun at day 8 and continued until end of cycle. If a significant incidence of dose limiting toxicities is demonstrated, Nintedanib will be given at a lower dose level (150mg bid).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
3/6 • Number of events 5 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
36.8%
7/19 • Number of events 24 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
50.0%
3/6 • Number of events 4 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
10.5%
2/19 • Number of events 2 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
3/6 • Number of events 3 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
68.4%
13/19 • Number of events 27 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Gastrointestinal disorders
Nausea
|
50.0%
3/6 • Number of events 3 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
63.2%
12/19 • Number of events 20 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
General disorders
Fatigue
|
33.3%
2/6 • Number of events 2 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
31.6%
6/19 • Number of events 8 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
General disorders
Infusion related reaction
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
15.8%
3/19 • Number of events 3 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
General disorders
Pain
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
36.8%
7/19 • Number of events 10 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Infections and infestations
Lung infection
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
0.00%
0/19 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Infections and infestations
Skin infection
|
33.3%
2/6 • Number of events 2 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
0.00%
0/19 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
2/6 • Number of events 3 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
52.6%
10/19 • Number of events 39 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
3/6 • Number of events 4 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
52.6%
10/19 • Number of events 24 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Investigations
Blood bilirubin increased
|
33.3%
2/6 • Number of events 5 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
31.6%
6/19 • Number of events 15 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Investigations
Fibrinogen decreased
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
0.00%
0/19 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Investigations
Neutrophil count decreased
|
33.3%
2/6 • Number of events 2 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
36.8%
7/19 • Number of events 23 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Investigations
Platelet count decreased
|
33.3%
2/6 • Number of events 10 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
31.6%
6/19 • Number of events 39 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Investigations
White blood cell decreased
|
50.0%
3/6 • Number of events 7 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
68.4%
13/19 • Number of events 51 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
57.9%
11/19 • Number of events 14 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
50.0%
3/6 • Number of events 5 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
63.2%
12/19 • Number of events 32 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
16.7%
1/6 • Number of events 2 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
36.8%
7/19 • Number of events 14 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
1/6 • Number of events 2 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
26.3%
5/19 • Number of events 7 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
16.7%
1/6 • Number of events 2 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
26.3%
5/19 • Number of events 7 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
21.1%
4/19 • Number of events 4 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Nervous system disorders
Dysgeusia
|
33.3%
2/6 • Number of events 2 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
15.8%
3/19 • Number of events 3 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 2 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
31.6%
6/19 • Number of events 13 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
36.8%
7/19 • Number of events 7 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
31.6%
6/19 • Number of events 8 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
0.00%
0/19 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
10.5%
2/19 • Number of events 2 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
0.00%
0/19 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
31.6%
6/19 • Number of events 9 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Vascular disorders
Hypertension
|
33.3%
2/6 • Number of events 2 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
52.6%
10/19 • Number of events 32 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
10.5%
2/19 • Number of events 2 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Cardiac disorders
Cardiac disorders - Other
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
10.5%
2/19 • Number of events 2 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
31.6%
6/19 • Number of events 8 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
10.5%
2/19 • Number of events 2 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Eye disorders
Blurred vision
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Eye disorders
Dry eye
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
10.5%
2/19 • Number of events 2 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Eye disorders
Eye disorders - Other
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Eye disorders
Photophobia
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
42.1%
8/19 • Number of events 13 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Gastrointestinal disorders
Cecal hemorrhage
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 2 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
36.8%
7/19 • Number of events 9 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
10.5%
2/19 • Number of events 2 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
10.5%
2/19 • Number of events 2 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
10.5%
2/19 • Number of events 4 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
15.8%
3/19 • Number of events 3 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
47.4%
9/19 • Number of events 15 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
10.5%
2/19 • Number of events 2 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
15.8%
3/19 • Number of events 3 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
10.5%
2/19 • Number of events 2 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
10.5%
2/19 • Number of events 2 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
36.8%
7/19 • Number of events 17 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
General disorders
Chills
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
31.6%
6/19 • Number of events 10 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
General disorders
Edema face
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
General disorders
Edema limbs
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
36.8%
7/19 • Number of events 9 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
General disorders
Fever
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
57.9%
11/19 • Number of events 27 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
General disorders
General disorders and administration site conditions - Other
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
General disorders
Neck edema
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Infections and infestations
Infections and infestations - Other
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
42.1%
8/19 • Number of events 11 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Infections and infestations
Papulopustular rash
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
21.1%
4/19 • Number of events 4 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
47.4%
9/19 • Number of events 16 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Investigations
Cardiac troponin T increased
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
10.5%
2/19 • Number of events 2 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Investigations
CPK increased
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 3 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Investigations
Creatinine increased
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 3 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Investigations
INR increased
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
36.8%
7/19 • Number of events 8 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
68.4%
13/19 • Number of events 65 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Investigations
Weight gain
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
15.8%
3/19 • Number of events 6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Investigations
Weight loss
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
15.8%
3/19 • Number of events 8 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
31.6%
6/19 • Number of events 9 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
10.5%
2/19 • Number of events 2 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
63.2%
12/19 • Number of events 26 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
42.1%
8/19 • Number of events 17 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
36.8%
7/19 • Number of events 12 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
15.8%
3/19 • Number of events 4 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
10.5%
2/19 • Number of events 2 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
10.5%
2/19 • Number of events 2 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
15.8%
3/19 • Number of events 3 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 2 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
31.6%
6/19 • Number of events 7 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Musculoskeletal and connective tissue disorders
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
36.8%
7/19 • Number of events 11 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Nervous system disorders
Nervous system disorders - Othe4
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
21.1%
4/19 • Number of events 6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Nervous system disorders
Sinus pain
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Psychiatric disorders
Agitation
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Psychiatric disorders
Confusion
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Psychiatric disorders
Delirium
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
15.8%
3/19 • Number of events 4 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
31.6%
6/19 • Number of events 6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
10.5%
2/19 • Number of events 2 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
31.6%
6/19 • Number of events 8 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
26.3%
5/19 • Number of events 10 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
10.5%
2/19 • Number of events 2 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
10.5%
2/19 • Number of events 2 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
15.8%
3/19 • Number of events 3 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 2 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
10.5%
2/19 • Number of events 2 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
21.1%
4/19 • Number of events 6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
10.5%
2/19 • Number of events 2 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
26.3%
5/19 • Number of events 6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
10.5%
2/19 • Number of events 2 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 2 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
21.1%
4/19 • Number of events 7 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
10.5%
2/19 • Number of events 2 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Vascular disorders
Flushing
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Vascular disorders
Hot flashes
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
21.1%
4/19 • Number of events 8 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
|
Vascular disorders
Vascular disorders - Other
|
0.00%
0/6 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
5.3%
1/19 • Number of events 1 • Adverse Events were collected for up to 60 days for Phase 1, up to 2 years for Phase 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place