Trial Outcomes & Findings for AMD3100 Plus Mitoxantrone, Etoposide and Cytarabine in Acute Myeloid Leukemia (NCT NCT00512252)
NCT ID: NCT00512252
Last Updated: 2016-12-12
Results Overview
A standard 3+3 design was used in the Phase I portion starting with the AMD3100 dose of 80 mcg/kg and escalating by 80 mcg/kg for each successive cohort up to a maximum of 240 mcg/kg/d. The optimal dose was defined as the highest dose of AMD3100 \<= 240 mcg/kg at which 0-1 of 6 patients experienced a dose limiting toxicity.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
52 participants
Primary outcome timeframe
Completion of all patients in Phase I portion (232 days)
Results posted on
2016-12-12
Participant Flow
Recruitment occurred from 07/12/2007 until 01/14/2010.
Participant milestones
| Measure |
Phase I Dose Escalation (Dose Level 1)
* AMD3100 SQ on days 0-5
* Mitoxantrone on days 1-5
* Etoposide on days 1-5
* Cytarabine on days 1-5
Dose Level 1 AMD3100 dose = 80 mcg/kg/d
|
Phase I Dose Escalation (Dose Level 2)
* AMD3100 SQ on days 0-5
* Mitoxantrone on days 1-5
* Etoposide on days 1-5
* Cytarabine on days 1-5
Dose Level 2 AMD3100 dose = 160 mcg/kg/d
|
Phase II Dose Treatment (Dose Level 3)
* AMD 3100 SQ on days 0-5
* Mitoxantrone on days 1-5
* Etoposide on days 1-5
* Cytarabine on days 1-5
Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose).
The 6 participants that were enrolled in Dose Level 3 in the Phase I portion of the study were carried over to the Phase II analysis. 40 additional patients were enrolled in the Phase II portion of the study using the Dose Level 3 dose.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
46
|
|
Overall Study
COMPLETED
|
3
|
3
|
43
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
3
|
Reasons for withdrawal
| Measure |
Phase I Dose Escalation (Dose Level 1)
* AMD3100 SQ on days 0-5
* Mitoxantrone on days 1-5
* Etoposide on days 1-5
* Cytarabine on days 1-5
Dose Level 1 AMD3100 dose = 80 mcg/kg/d
|
Phase I Dose Escalation (Dose Level 2)
* AMD3100 SQ on days 0-5
* Mitoxantrone on days 1-5
* Etoposide on days 1-5
* Cytarabine on days 1-5
Dose Level 2 AMD3100 dose = 160 mcg/kg/d
|
Phase II Dose Treatment (Dose Level 3)
* AMD 3100 SQ on days 0-5
* Mitoxantrone on days 1-5
* Etoposide on days 1-5
* Cytarabine on days 1-5
Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose).
The 6 participants that were enrolled in Dose Level 3 in the Phase I portion of the study were carried over to the Phase II analysis. 40 additional patients were enrolled in the Phase II portion of the study using the Dose Level 3 dose.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
|
Overall Study
Death
|
0
|
0
|
1
|
Baseline Characteristics
AMD3100 Plus Mitoxantrone, Etoposide and Cytarabine in Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Phase I Dose Escalation (Dose Level 1)
n=3 Participants
* AMD3100 SQ on days 0-5
* Mitoxantrone on days 1-5
* Etoposide on days 1-5
* Cytarabine on days 1-5
Dose Level 1 AMD3100 dose = 80 mcg/kg/d
|
Phase I Dose Escalation (Dose Level 2)
n=3 Participants
* AMD3100 SQ on days 0-5
* Mitoxantrone on days 1-5
* Etoposide on days 1-5
* Cytarabine on days 1-5
Dose Level 2 AMD3100 dose = 160 mcg/kg/d
|
Phase II Dose Treatment (Dose Level 3)
n=46 Participants
* AMD 3100 SQ on days 0-5
* Mitoxantrone on days 1-5
* Etoposide on days 1-5
* Cytarabine on days 1-5
Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose).
The 6 participants that were enrolled in Dose Level 3 in the Phase I portion of the study were carried over to the Phase II analysis. 40 additional patients were enrolled in the Phase II portion of the study using the Dose Level 3 dose.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Age, Continuous
|
58 years
n=5 Participants
|
24 years
n=7 Participants
|
51 years
n=5 Participants
|
51 years
n=4 Participants
|
|
Gender
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Gender
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
46 participants
n=5 Participants
|
52 participants
n=4 Participants
|
|
Acute myeloid leukemia (AML) source
De novo AML
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
36 participants
n=5 Participants
|
41 participants
n=4 Participants
|
|
Acute myeloid leukemia (AML) source
Therapy related
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Acute myeloid leukemia (AML) source
Prior MDS/MPD
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Prior transplantation
Autologous
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Prior transplantation
Allogeneic
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Prior transplantation
No prior transplant
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
37 participants
n=5 Participants
|
43 participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
25 participants
n=5 Participants
|
29 participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
10 participants
n=5 Participants
|
12 participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
2
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Unknown
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
8 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Treatment Indication
First relapse, first salvage
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
32 participants
n=5 Participants
|
37 participants
n=4 Participants
|
|
Treatment Indication
Primary refractory
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
10 participants
n=5 Participants
|
11 participants
n=4 Participants
|
|
Treatment Indication
>=Second relapse/salvage
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
4 participants
n=5 Participants
|
4 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Completion of all patients in Phase I portion (232 days)Population: The Phase I Dose Escalation portion included (3) patients enrolled in Dose Level 1 and (3) patients enrolled in Dose Level 2. The (6) patients enrolled in Dose Level 3 that determined the Phase II dose are included in the population for this outcome.
A standard 3+3 design was used in the Phase I portion starting with the AMD3100 dose of 80 mcg/kg and escalating by 80 mcg/kg for each successive cohort up to a maximum of 240 mcg/kg/d. The optimal dose was defined as the highest dose of AMD3100 \<= 240 mcg/kg at which 0-1 of 6 patients experienced a dose limiting toxicity.
Outcome measures
| Measure |
Phase I Dose Escalation
n=12 Participants
* AMD3100 SQ on days 0-5
* Mitoxantrone on days 1-5
* Etoposide on days 1-5
* Cytarabine on days 1-5
Dose Level 1 AMD3100 dose = 80 mcg/kg/d
Dose Level 2 AMD3100 dose = 160 mcg/kg/d
Dose Level 3 AMD3100 dose = 240 mcg/kg/d
|
Primary Refractory
|
>= Second Relapse/Salvage
|
Total
Phase II Dose Patients
|
|---|---|---|---|---|
|
Phase I Only: Optimal Dose of AMD3100 Plus MEC in Patients With Relapsed or Refractory AML
|
240 mcg/kg
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 42 daysResponses were assessed according to the International Working Group Criteria for AML. All patients who received at least one dose of AMD3100 were considered evaluable for response. Response rate was the rate of complete remission plus complete remission with incomplete blood count recovery (CR + CRi).
Outcome measures
| Measure |
Phase I Dose Escalation
n=32 Participants
* AMD3100 SQ on days 0-5
* Mitoxantrone on days 1-5
* Etoposide on days 1-5
* Cytarabine on days 1-5
Dose Level 1 AMD3100 dose = 80 mcg/kg/d
Dose Level 2 AMD3100 dose = 160 mcg/kg/d
Dose Level 3 AMD3100 dose = 240 mcg/kg/d
|
Primary Refractory
n=10 Participants
|
>= Second Relapse/Salvage
n=4 Participants
|
Total
n=46 Participants
Phase II Dose Patients
|
|---|---|---|---|---|
|
Phase II Only: Complete Response Rate of AMD3100 + MEC
CR + CRi
|
56 percentage of participants
|
20 percentage of participants
|
25 percentage of participants
|
46 percentage of participants
|
|
Phase II Only: Complete Response Rate of AMD3100 + MEC
CR only
|
47 percentage of participants
|
20 percentage of participants
|
25 percentage of participants
|
39 percentage of participants
|
PRIMARY outcome
Timeframe: 42 daysPopulation: This outcome was not analyzed as data was not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 42 daysPopulation: The 46 patients include the 6 patients treated on Dose Level 3 of the Phase I portion of the study.
Treatment related mortality (deaths occurring during treatment)
Outcome measures
| Measure |
Phase I Dose Escalation
n=46 Participants
* AMD3100 SQ on days 0-5
* Mitoxantrone on days 1-5
* Etoposide on days 1-5
* Cytarabine on days 1-5
Dose Level 1 AMD3100 dose = 80 mcg/kg/d
Dose Level 2 AMD3100 dose = 160 mcg/kg/d
Dose Level 3 AMD3100 dose = 240 mcg/kg/d
|
Primary Refractory
|
>= Second Relapse/Salvage
|
Total
Phase II Dose Patients
|
|---|---|---|---|---|
|
Safety and Tolerability of AMD3100 + MEC.
Sepsis
|
2 participants
|
—
|
—
|
—
|
|
Safety and Tolerability of AMD3100 + MEC.
Adverse transfusion reaction w/febrile neutropenia
|
1 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 42 daysPopulation: This analysis includes patients who achieved a CR or a CRi.
Defined as the date of the first dose of AMD3100 to the date that the absolute neutrophil count \>1,000 cells/mm\^3.
Outcome measures
| Measure |
Phase I Dose Escalation
n=21 Participants
* AMD3100 SQ on days 0-5
* Mitoxantrone on days 1-5
* Etoposide on days 1-5
* Cytarabine on days 1-5
Dose Level 1 AMD3100 dose = 80 mcg/kg/d
Dose Level 2 AMD3100 dose = 160 mcg/kg/d
Dose Level 3 AMD3100 dose = 240 mcg/kg/d
|
Primary Refractory
|
>= Second Relapse/Salvage
|
Total
Phase II Dose Patients
|
|---|---|---|---|---|
|
Time to Neutrophil Recovery
|
28 days
Interval 21.0 to 46.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 42 daysPopulation: This analysis includes patients who achieved a CR.
Defined as the date of the first dose of AMD3100 to the date that the platelet count is \>100,000/mm3 in the absence of platelet transfusions.
Outcome measures
| Measure |
Phase I Dose Escalation
n=18 Participants
* AMD3100 SQ on days 0-5
* Mitoxantrone on days 1-5
* Etoposide on days 1-5
* Cytarabine on days 1-5
Dose Level 1 AMD3100 dose = 80 mcg/kg/d
Dose Level 2 AMD3100 dose = 160 mcg/kg/d
Dose Level 3 AMD3100 dose = 240 mcg/kg/d
|
Primary Refractory
|
>= Second Relapse/Salvage
|
Total
Phase II Dose Patients
|
|---|---|---|---|---|
|
Time to Platelet Recovery
|
28.5 days
Interval 16.0 to 42.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0Measured at 0 hours, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, and 24 hours after AMD3100 dose on Day 0. Characterization of the mobilized cells as well as the kinetics of mobilization will be determined by analyzing the surface expression of mobilized cells by flow cytometry at the specified time points in conjunction with their total leukocyte count from the patient's CBC.
Outcome measures
| Measure |
Phase I Dose Escalation
n=3 Participants
* AMD3100 SQ on days 0-5
* Mitoxantrone on days 1-5
* Etoposide on days 1-5
* Cytarabine on days 1-5
Dose Level 1 AMD3100 dose = 80 mcg/kg/d
Dose Level 2 AMD3100 dose = 160 mcg/kg/d
Dose Level 3 AMD3100 dose = 240 mcg/kg/d
|
Primary Refractory
n=3 Participants
|
>= Second Relapse/Salvage
n=6 Participants
|
Total
Phase II Dose Patients
|
|---|---|---|---|---|
|
Characterize the Mobilization of Leukemic Cells With AMD3100 by Measuring the Peak Mobilization of Total Leukocytes (Phase I)
Total leukocytes at 4 hours
|
4.7 cells x 10^3/microliter
Interval 3.4 to 10.8
|
9.4 cells x 10^3/microliter
Interval 3.8 to 12.1
|
8.3 cells x 10^3/microliter
Interval 2.0 to 38.6
|
—
|
|
Characterize the Mobilization of Leukemic Cells With AMD3100 by Measuring the Peak Mobilization of Total Leukocytes (Phase I)
Total leukocytes at 6 hours
|
4.8 cells x 10^3/microliter
Interval 3.9 to 17.0
|
11.3 cells x 10^3/microliter
Interval 4.3 to 14.3
|
9.5 cells x 10^3/microliter
Interval 2.1 to 32.0
|
—
|
|
Characterize the Mobilization of Leukemic Cells With AMD3100 by Measuring the Peak Mobilization of Total Leukocytes (Phase I)
Total leukocytes at 2 hours
|
4 cells x 10^3/microliter
Interval 3.2 to 7.9
|
8.5 cells x 10^3/microliter
Interval 3.7 to 11.3
|
7.5 cells x 10^3/microliter
Interval 2.0 to 27.0
|
—
|
|
Characterize the Mobilization of Leukemic Cells With AMD3100 by Measuring the Peak Mobilization of Total Leukocytes (Phase I)
Total leukocytes at 0 hours
|
2.5 cells x 10^3/microliter
Interval 1.9 to 3.0
|
4.7 cells x 10^3/microliter
Interval 2.9 to 6.1
|
3.5 cells x 10^3/microliter
Interval 1.2 to 16.5
|
—
|
|
Characterize the Mobilization of Leukemic Cells With AMD3100 by Measuring the Peak Mobilization of Total Leukocytes (Phase I)
Total leukocytes at 1 hour
|
4.3 cells x 10^3/microliter
Interval 2.7 to 6.9
|
7.0 cells x 10^3/microliter
Interval 3.9 to 10.8
|
6.4 cells x 10^3/microliter
Interval 3.4 to 24.5
|
—
|
|
Characterize the Mobilization of Leukemic Cells With AMD3100 by Measuring the Peak Mobilization of Total Leukocytes (Phase I)
Total leukocytes at 8 hours
|
4.5 cells x 10^3/microliter
Interval 3.6 to 11.5
|
12.0 cells x 10^3/microliter
Interval 4.4 to 16.3
|
8.9 cells x 10^3/microliter
Interval 2.3 to 39.0
|
—
|
|
Characterize the Mobilization of Leukemic Cells With AMD3100 by Measuring the Peak Mobilization of Total Leukocytes (Phase I)
Total leukocytes at 12 hours
|
5.1 cells x 10^3/microliter
Interval 2.8 to 13.2
|
12.1 cells x 10^3/microliter
Interval 5.1 to 16.0
|
7.8 cells x 10^3/microliter
Interval 2.0 to 38.9
|
—
|
|
Characterize the Mobilization of Leukemic Cells With AMD3100 by Measuring the Peak Mobilization of Total Leukocytes (Phase I)
Total leukocytes at 24 hours
|
4.3 cells x 10^3/microliter
Interval 1.7 to 8.1
|
7.9 cells x 10^3/microliter
Interval 3.4 to 11.7
|
5.8 cells x 10^3/microliter
Interval 1.5 to 22.2
|
—
|
SECONDARY outcome
Timeframe: Day 0Measured at 0 hours, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, and 24 hours after AMD3100 dose on Day 0.
Outcome measures
| Measure |
Phase I Dose Escalation
n=3 Participants
* AMD3100 SQ on days 0-5
* Mitoxantrone on days 1-5
* Etoposide on days 1-5
* Cytarabine on days 1-5
Dose Level 1 AMD3100 dose = 80 mcg/kg/d
Dose Level 2 AMD3100 dose = 160 mcg/kg/d
Dose Level 3 AMD3100 dose = 240 mcg/kg/d
|
Primary Refractory
n=3 Participants
|
>= Second Relapse/Salvage
n=6 Participants
|
Total
Phase II Dose Patients
|
|---|---|---|---|---|
|
Characterize the Mobilization of Leukemic Cells With AMD3100 by Measuring the Peak Mobilization of AML Blasts (Phase I)
AML blasts at 0 hours
|
46.0 percentage of AML blasts
Interval 2.0 to 54.0
|
4.0 percentage of AML blasts
The AML blasts at 0 hour was not performed on 2 out of the 3 patients.
|
43.5 percentage of AML blasts
Interval 10.0 to 77.0
|
—
|
|
Characterize the Mobilization of Leukemic Cells With AMD3100 by Measuring the Peak Mobilization of AML Blasts (Phase I)
AML blasts at 1 hour
|
26.0 percentage of AML blasts
Interval 5.0 to 34.0
|
9.0 percentage of AML blasts
The AML blasts at 0 hour was not performed on 2 out of the 3 patients.
|
30.5 percentage of AML blasts
Interval 9.0 to 68.0
|
—
|
|
Characterize the Mobilization of Leukemic Cells With AMD3100 by Measuring the Peak Mobilization of AML Blasts (Phase I)
AML blasts at 2 hours
|
26.0 percentage of AML blasts
Interval 3.0 to 40.0
|
37.5 percentage of AML blasts
Interval 3.0 to 72.0
|
32.5 percentage of AML blasts
Interval 5.0 to 67.0
|
—
|
|
Characterize the Mobilization of Leukemic Cells With AMD3100 by Measuring the Peak Mobilization of AML Blasts (Phase I)
AML blasts at 4 hours
|
37.0 percentage of AML blasts
Interval 4.0 to 46.0
|
16.0 percentage of AML blasts
Interval 1.0 to 64.0
|
30.0 percentage of AML blasts
Interval 4.0 to 60.0
|
—
|
|
Characterize the Mobilization of Leukemic Cells With AMD3100 by Measuring the Peak Mobilization of AML Blasts (Phase I)
AML blasts at 6 hours
|
31.0 percentage of AML blasts
Interval 2.0 to 53.0
|
14.0 percentage of AML blasts
Interval 2.0 to 63.0
|
27.0 percentage of AML blasts
Interval 9.0 to 74.0
|
—
|
|
Characterize the Mobilization of Leukemic Cells With AMD3100 by Measuring the Peak Mobilization of AML Blasts (Phase I)
AML blasts at 8 hours
|
32.0 percentage of AML blasts
Interval 5.0 to 52.0
|
19.0 percentage of AML blasts
Interval 6.0 to 67.0
|
26.0 percentage of AML blasts
Interval 8.0 to 70.0
|
—
|
|
Characterize the Mobilization of Leukemic Cells With AMD3100 by Measuring the Peak Mobilization of AML Blasts (Phase I)
AML blasts at 12 hours
|
27.0 percentage of AML blasts
Interval 2.0 to 30.0
|
45.0 percentage of AML blasts
Interval 21.0 to 69.0
|
35.0 percentage of AML blasts
Interval 14.0 to 82.0
|
—
|
|
Characterize the Mobilization of Leukemic Cells With AMD3100 by Measuring the Peak Mobilization of AML Blasts (Phase I)
AML blasts at 24 hours
|
35.0 percentage of AML blasts
Interval 3.0 to 52.0
|
23 percentage of AML blasts
Interval 13.0 to 33.0
|
55 percentage of AML blasts
Interval 12.0 to 68.0
|
—
|
SECONDARY outcome
Timeframe: Day 1 - Phase 2 onlyPopulation: This was not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 6 monthsPopulation: This outcome was not analyzed instead "reason for treatment failure" was analyzed as it provided better information on why the treatment did not work.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 42 daysTreatment failures includes those patients for whom treatment has failed to achieve a CR or a CRi.
Outcome measures
| Measure |
Phase I Dose Escalation
n=14 Participants
* AMD3100 SQ on days 0-5
* Mitoxantrone on days 1-5
* Etoposide on days 1-5
* Cytarabine on days 1-5
Dose Level 1 AMD3100 dose = 80 mcg/kg/d
Dose Level 2 AMD3100 dose = 160 mcg/kg/d
Dose Level 3 AMD3100 dose = 240 mcg/kg/d
|
Primary Refractory
n=8 Participants
|
>= Second Relapse/Salvage
n=3 Participants
|
Total
n=25 Participants
Phase II Dose Patients
|
|---|---|---|---|---|
|
Treatment Failure
Persistent leukemia
|
12 participants
|
6 participants
|
3 participants
|
21 participants
|
|
Treatment Failure
Death during aplasia
|
1 participants
|
2 participants
|
0 participants
|
3 participants
|
|
Treatment Failure
Unknown
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
Phase I Dose Escalation
n=46 Participants
* AMD3100 SQ on days 0-5
* Mitoxantrone on days 1-5
* Etoposide on days 1-5
* Cytarabine on days 1-5
Dose Level 1 AMD3100 dose = 80 mcg/kg/d
Dose Level 2 AMD3100 dose = 160 mcg/kg/d
Dose Level 3 AMD3100 dose = 240 mcg/kg/d
|
Primary Refractory
|
>= Second Relapse/Salvage
|
Total
Phase II Dose Patients
|
|---|---|---|---|---|
|
Overall Survival
|
37 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 yearPopulation: This excludes the 25 participants who had treatment failure.
This is determined only for patients achieving a complete remission. Defined as the interval from the date of the first documentation of a leukemia free state to date of recurrence or death due to any cause. Kaplain-Meier estimate was used.
Outcome measures
| Measure |
Phase I Dose Escalation
n=21 Participants
* AMD3100 SQ on days 0-5
* Mitoxantrone on days 1-5
* Etoposide on days 1-5
* Cytarabine on days 1-5
Dose Level 1 AMD3100 dose = 80 mcg/kg/d
Dose Level 2 AMD3100 dose = 160 mcg/kg/d
Dose Level 3 AMD3100 dose = 240 mcg/kg/d
|
Primary Refractory
|
>= Second Relapse/Salvage
|
Total
Phase II Dose Patients
|
|---|---|---|---|---|
|
Relapse-free Survival
|
42.9 percentage of participants
|
—
|
—
|
—
|
Adverse Events
Phase I Dose Escalation (Dose Level 1)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase I Dose Escalation (Dose Level 2)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase II Dose Treatment (Dose Level 3)
Serious events: 3 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I Dose Escalation (Dose Level 1)
n=3 participants at risk
* AMD3100 SQ on days 0-5
* Mitoxantrone on days 1-5
* Etoposide on days 1-5
* Cytarabine on days 1-5
Dose Level 1 AMD3100 dose = 80 mcg/kg/d
|
Phase I Dose Escalation (Dose Level 2)
n=3 participants at risk
* AMD3100 SQ on days 0-5
* Mitoxantrone on days 1-5
* Etoposide on days 1-5
* Cytarabine on days 1-5
Dose Level 2 AMD3100 dose = 160 mcg/kg/d
|
Phase II Dose Treatment (Dose Level 3)
n=46 participants at risk
* AMD 3100 SQ on days 0-5
* Mitoxantrone on days 1-5
* Etoposide on days 1-5
* Cytarabine on days 1-5
Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose).
The 6 participants that were enrolled in Dose Level 3 in the Phase I portion of the study were carried over to the Phase II analysis. 40 additional patients were enrolled in the Phase II portion of the study using the Dose Level 3 dose.
|
|---|---|---|---|
|
Immune system disorders
Allergic reaction - platelet transfusion
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Cardiac disorders
Hypotension
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Infections and infestations
Infection-other (gram negative sepsis)
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
Other adverse events
| Measure |
Phase I Dose Escalation (Dose Level 1)
n=3 participants at risk
* AMD3100 SQ on days 0-5
* Mitoxantrone on days 1-5
* Etoposide on days 1-5
* Cytarabine on days 1-5
Dose Level 1 AMD3100 dose = 80 mcg/kg/d
|
Phase I Dose Escalation (Dose Level 2)
n=3 participants at risk
* AMD3100 SQ on days 0-5
* Mitoxantrone on days 1-5
* Etoposide on days 1-5
* Cytarabine on days 1-5
Dose Level 2 AMD3100 dose = 160 mcg/kg/d
|
Phase II Dose Treatment (Dose Level 3)
n=46 participants at risk
* AMD 3100 SQ on days 0-5
* Mitoxantrone on days 1-5
* Etoposide on days 1-5
* Cytarabine on days 1-5
Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose).
The 6 participants that were enrolled in Dose Level 3 in the Phase I portion of the study were carried over to the Phase II analysis. 40 additional patients were enrolled in the Phase II portion of the study using the Dose Level 3 dose.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
66.7%
2/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
100.0%
3/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
21.7%
10/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Pregnancy, puerperium and perinatal conditions
Red and swollen left labia
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Investigations
Neutrophils
|
100.0%
3/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
45.7%
21/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Infections and infestations
Opportunistic infection (pneumonia NOS)
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
4.3%
2/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Infections and infestations
Opportunistic infection - urinary tract
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Infections and infestations
Opportunistic infection, nasal
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Respiratory, thoracic and mediastinal disorders
Pain upon inspiration
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Gastrointestinal disorders
Perianal pain
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
General disorders
Petichiae
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
13.0%
6/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Injury, poisoning and procedural complications
Pilonidal cyst
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Investigations
Platelets
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
66.7%
2/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
50.0%
23/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Investigations
ALT
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
30.4%
14/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Investigations
AST
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
23.9%
11/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Gastrointestinal disorders
Abdominal cramping
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
6.5%
3/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
66.7%
2/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
21.7%
10/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Skin and subcutaneous tissue disorders
Acute febrile neutrophilic dermatosis
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Psychiatric disorders
Agitation
|
66.7%
2/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
4.3%
2/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Investigations
Alkaline phosphatase
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
43.5%
20/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Immune system disorders
Allergic reaction - NOS
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Immune system disorders
Allergic reaction - general itching during transfusion
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Immune system disorders
Allergic reaction - platelet transfusion
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
66.7%
2/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
54.3%
25/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Psychiatric disorders
Anxiety
|
66.7%
2/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
100.0%
3/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
23.9%
11/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
66.7%
2/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
66.7%
2/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
17.4%
8/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
General disorders
Bilateral extremity echymosis
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
General disorders
Bilateral extremity petichiae
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
4.3%
2/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Renal and urinary disorders
Bladder spasms
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Eye disorders
Blurred vison
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
10.9%
5/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Musculoskeletal and connective tissue disorders
Bone marrow biopsy site pain
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
66.7%
2/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
17.4%
8/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
4.3%
2/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Skin and subcutaneous tissue disorders
Bumps on legs and arms
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Renal and urinary disorders
Catheter site insertion pain
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
6.5%
3/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Infections and infestations
Cellulitis
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Cardiac disorders
Chest pain
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
8.7%
4/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
General disorders
Chills
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
13.0%
6/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Psychiatric disorders
Claustrophobia
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Musculoskeletal and connective tissue disorders
Coccyx pain
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
4.3%
2/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Nervous system disorders
Cognitive disturbance - lethargy
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Gastrointestinal disorders
Colitis
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Infections and infestations
Colitis, infectious - clostridium difficile
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
8.7%
4/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
10.9%
5/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
66.7%
2/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
21.7%
10/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
28.3%
13/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
8.7%
4/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
General disorders
Diaphoresis
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
4.3%
2/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
2/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
66.7%
2/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
56.5%
26/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Gastrointestinal disorders
Distension
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
10.9%
5/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Gastrointestinal disorders
Dysphagia
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
21.7%
10/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Renal and urinary disorders
Dysuria
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
General disorders
Edema face
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
15.2%
7/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
General disorders
Edema limbs
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
37.0%
17/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
General disorders
Edema trunk
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
4.3%
2/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Gastrointestinal disorders
Epigastric pain
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Gastrointestinal disorders
Esophagus pain
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Musculoskeletal and connective tissue disorders
Extremity pain
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Musculoskeletal and connective tissue disorders
Facial pain
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
General disorders
Fatigue
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
66.7%
2/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
30.4%
14/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
100.0%
3/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
100.0%
3/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
67.4%
31/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
General disorders
Fever
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
8.7%
4/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Musculoskeletal and connective tissue disorders
Generalized bone pain
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
4.3%
2/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
General disorders
Generalized edema
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
6.5%
3/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Musculoskeletal and connective tissue disorders
Generalized joint pain
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
4.3%
2/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
General disorders
Generalized pain
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Nervous system disorders
Headache
|
66.7%
2/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
100.0%
3/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
41.3%
19/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Gastrointestinal disorders
Heartburn
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
6.5%
3/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Gastrointestinal disorders
Hematemesis
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
4.3%
2/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
General disorders
Hematoma
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
8.7%
4/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Investigations
Hemoglobin
|
100.0%
3/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
66.7%
2/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
37.0%
17/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Eye disorders
Hemorrhage - eye
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
4.3%
2/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage - nose
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
8.7%
4/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Gastrointestinal disorders
Hemorrhoidal pain
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Gastrointestinal disorders
Hemorrhoids
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Musculoskeletal and connective tissue disorders
Hip pain
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
6.5%
3/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Investigations
Hyperbilirubinemia
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
15.2%
7/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
4.3%
2/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Investigations
Hypernatremia
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Cardiac disorders
Hypertension
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
23.9%
11/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Investigations
Hypoalbuminemia
|
66.7%
2/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
100.0%
3/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
37.0%
17/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Investigations
Hypocalcemia
|
100.0%
3/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
43.5%
20/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Investigations
Hypokalemia
|
66.7%
2/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
23.9%
11/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Investigations
Hyponatremia
|
100.0%
3/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
15.2%
7/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Investigations
Hypophosphatemia
|
66.7%
2/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
13.0%
6/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Cardiac disorders
Hypotension
|
66.7%
2/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
21.7%
10/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
General disorders
Hypothermia
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Injury, poisoning and procedural complications
Incisional pain
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
6.5%
3/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Renal and urinary disorders
Incontinence - secondary to urinary urgency
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Gastrointestinal disorders
Indigestion
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Infections and infestations
Infection, gram positive cocci
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Injury, poisoning and procedural complications
Injection site pain
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
General disorders
Injection site reaction
|
66.7%
2/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
15.2%
7/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
30.4%
14/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Skin and subcutaneous tissue disorders
Itching (pruritus)
|
66.7%
2/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
21.7%
10/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Hepatobiliary disorders
Jaundice - right eye
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Musculoskeletal and connective tissue disorders
Jaw pain
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
4.3%
2/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Musculoskeletal and connective tissue disorders
Left arm pain
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Musculoskeletal and connective tissue disorders
Left elbow pain
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Gastrointestinal disorders
Left lower abdominal pain
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
4.3%
2/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Investigations
Leukocytes
|
100.0%
3/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
100.0%
3/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
82.6%
38/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
General disorders
Lip swelling
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Infections and infestations
Liver abcess
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Injury, poisoning and procedural complications
Lower back wound pain
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Musculoskeletal and connective tissue disorders
Lower extremity pain
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
6.5%
3/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Investigations
Lymphopenia
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
4.3%
2/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Psychiatric disorders
Mood alteration (not specified)
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Musculoskeletal and connective tissue disorders
Mouth pain
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Musculoskeletal and connective tissue disorders
Mouth pain - right side
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Gastrointestinal disorders
Mucositis (oral and stomach)
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
66.7%
2/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
71.7%
33/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness - generalized
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
52.2%
24/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Infections and infestations
Nasal/paranasal reactions - sinusitis
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
4.3%
2/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
100.0%
3/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
71.7%
33/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
66.7%
2/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
6.5%
3/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Nervous system disorders
Neuropathy (not specified)
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Nervous system disorders
Neuropathy - bilateral feet
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
4.3%
2/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Nervous system disorders
Neuropathy - bilateral hands
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Nervous system disorders
Neuropathy - face
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Nervous system disorders
Neuropathy - left eye droop
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Nervous system disorders
Neuropathy - left hand
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Nervous system disorders
Neuropathy - right ankle
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Nervous system disorders
Neuropathy - toes
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
6.5%
3/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Nervous system disorders
Restless leg syndrome
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Musculoskeletal and connective tissue disorders
Rib pain
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Musculoskeletal and connective tissue disorders
Right arm pain
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Ear and labyrinth disorders
Right ear pain
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
66.7%
2/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Musculoskeletal and connective tissue disorders
Right forearm pain
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Musculoskeletal and connective tissue disorders
Right head and neck pain
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Musculoskeletal and connective tissue disorders
Right hip pain
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Musculoskeletal and connective tissue disorders
Right jaw pain
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Musculoskeletal and connective tissue disorders
Right side pain
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Gastrointestinal disorders
Right upper quadrant pain
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
6.5%
3/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
4.3%
2/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Cardiac disorders
Tachycardia
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
66.7%
2/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
63.0%
29/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
8.7%
4/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Gastrointestinal disorders
Taste alteration
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
8.7%
4/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Respiratory, thoracic and mediastinal disorders
Throat pain
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
13.0%
6/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
General disorders
Tooth pain
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
6.5%
3/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
6.5%
3/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Renal and urinary disorders
Urinary hesitancy
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Renal and urinary disorders
Urinary retention
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
4.3%
2/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Pregnancy, puerperium and perinatal conditions
Vaginal bleeding
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Cardiac disorders
Vasovagal episode
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
33.3%
1/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Eye disorders
Vision - floaters
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
4.3%
2/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Eye disorders
Visual changes
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
2/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
100.0%
3/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
37.0%
17/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Gastrointestinal disorders
Weight loss
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Injury, poisoning and procedural complications
Wound - coccyx
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
General disorders
Weakness
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Infections and infestations
Infection - gram negative sepsis
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
|
Infections and infestations
Infection - gram negative bacilli
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
0.00%
0/3 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
2.2%
1/46 • Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
|
Additional Information
Geoffrey L. Uy, M.D.
Washington University School of Medicine
Phone: 314-454-8304
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place