An Investigational Immuno-therapy Study of Ulocuplumab in Combination With Low Dose Cytarabine in Patients With Newly Diagnosed Acute Myeloid Leukemia
Study Details
Study Description
Brief Summary
The purpose of this study is to determine the safety and effectiveness of ulocuplumab in combination with low dose cytarabine in the treatment of Newly Diagnosed Acute Myeloid Leukemia (AML).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1/Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Ulocuplumab + low dose Cytarabine Ulocuplumab + low dose Cytarabine (LDAC) Phase 1 (escalation cohort) - closed for enrollment |
Drug: BMS-936564
Other Names:
Drug: Cytarabine
|
Experimental: Ulocuplumab Dose A + low dose Cytarabine Ulocuplumab Dose A + low dose Cytarabine Phase 2 (expansion cohort) |
Drug: BMS-936564
Other Names:
Drug: Cytarabine
|
Experimental: Ulocuplumab Dose B + low dose Cytarabine Ulocuplumab Dose B + low dose Cytarabine Phase 2 (expansion cohort) |
Drug: BMS-936564
Other Names:
Drug: Cytarabine
|
Other: low dose Cytarabine only Low Dose Cytarabine only Phase 2 (expansion cohort) |
Drug: BMS-936564
Other Names:
Drug: Cytarabine
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Dose-Limiting Toxicities (DLTs) in Treatment Cycle 1 - Phase 1 [From first dose to end of cycle 1 (28 days)]
Safety data evaluated for DLTs. DLTs and all other toxicities were defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03). DLTs were defined based upon events that were considered to be related to ulocuplumab in combination with LDAC and that occurred during the first cycle of drug administration (28 days).
- Number of Participants With Adverse Events (AEs) - Phase 1 [From first dose to 30 days post last dose]
The number of participants with an on-study adverse event (AE). Safety data are evaluated for AEs, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03).
- Number of Participants With >= Grade 3 AEs - Phase 1 [From first dose to 30 days post last dose]
The number of participants with an on-study adverse event >= Grade level 3. Safety data are evaluated for >= Grade 3 AEs, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03).
- Number of Participants With AEs Leading to Discontinuation - Phase 1 [From first dose to 30 days post last dose]
The number of participants with an on-study adverse event (AE) leading to discontinuation. Safety data are evaluated for AEs leading to discontinuation, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03).
- Number of Participants With Serious Adverse Events (SAEs) - Phase 1 [From first dose to 30 days post last dose]
The number of participants with an on-study serious adverse event (SAE). Safety data are evaluated for SAEs, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03).
- Number of Deaths - Phase 1 [From first dose to 30 days post last dose]
The number of participants who died.
- Number of Participants With Laboratory Abnormalities - Phase 1 [From first dose to 30 days post last dose]
The number of participants with an on-study laboratory abnormality. Safety data are evaluated for laboratory abnormalities, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03). grades 1, 2, 3, 4, 5, unknown, with 5 being the worst outcome
- Best Overall Response (BOR) - Phase 2 [From first dose until a minimum follow-up of up to 2 months]
The phase 2 primary endpoint was based on the rate of Complete Remission (CR/CRi) prior to the initiation of any alternative therapy (including any subsequent ulocuplumab 800 mg for participants in the LDAC alone arm). The phase 2 primary analysis was conducted after all participants had an opportunity for 6 months of follow-up. Complete remission rate: CR + CRi, confidence interval based on the Clopper and Pearson method. CR = complete response CRi = complete response, incomplete blood count
Secondary Outcome Measures
- Best Overall Response (BOR) - Phase 1 [From first dose until a minimum follow-up of up to 2 months]
Investigator assessed best overall response prior to the initiation of any alternative therapy for Phase 1 participants.
- Number of Participants With AEs - Phase 2 [From first dose until a minimum follow-up of up to 2 months]
The number of participants with an on-study adverse event (AE). Safety data are evaluated for AEs, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03).
- Number of Participants With AEs Leading to Discontinuation - Phase 2 [From first dose until a minimum follow-up of up to 2 months]
The number of participants with an on-study adverse event (AE) leading to discontinuation. Safety data are evaluated for AEs leading to discontinuation, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03).
- Number of Participants With SAEs - Phase 2 [From first dose until a minimum follow-up of up to 2 months]
The number of participants with an on-study serious adverse event (SAE). Safety data are evaluated for SAEs, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03).
- Number of Deaths- Phase 2 [From first dose until a minimum follow-up of up to 2 months]
The number of participants who died. Safety data are evaluated for deaths, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03).
- Number of Participants With Laboratory Abnormalities - Phase 2 [From first dose until a minimum follow-up of up to 2 months]
The number of participants with an on-study laboratory abnormality, assessed from Grade 1-4 Serum Chemistry, Electrolytes, and Hematology Laboratory Test results, with grade 4 being the worst. Safety data are evaluated for laboratory abnormalities, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03).
- Number of Participants With Anti-drug Antibodies (ADA) Positive for Ulocuplumab - Phases 1 and 2 [From first dose until a minimum follow-up of up to 2 months]
Serum samples from ulocuplumab treated participants were evaluated for the presence of anti-ulocuplumab antibodies
- Maximum Observed Serum Concentration (Cmax) - Phases 1 and 2 [Cycle 1 Day 1]
The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration EOT = end of treatment Measure type and method of dispersion are Geometric mean and %CV, respectively
- Trough Observed Serum Concentration (Ctrough) - Phases 1 and 2 [Days 1, 8, 15 for cycle 1; Days 8, 15 for cycle 2; Days 1, 8 for cycles 3-5; Day 1 every 4th cycle thereafter; EOT; 30 days post last dose (follow-up)]
The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration. EOT = end of treatment Measure type and method of dispersion are Geometric mean and %CV, respectively
- Time of Maximum Observed Ulocuplumab Serum Concentration (Tmax) - Phases 1 and 2 [Cycle 1 Day 1]
The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration. EOT = end of treatment
- Area Under the Ulocuplumab Concentration-time Curve From Time Zero to the Last Quantifiable Concentration [AUC(0-T)] - Phases 1 and 2 [Cycle 1 Day 1]
The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration. EOT = end of treatment AUC(0-T) calculated by log- and linear-trapezoidal summation Measure type and method of dispersion are Geometric mean and %CV, respectively
- Area Under the Ulocuplumab Concentration-time Curve in One Dosing Interval [AUC(TAU)] - Phases 1 and 2 [Cycle 1 Day 1]
The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration. EOT = end of treatment Measure type and method of dispersion are Geometric mean and %CV, respectively
- Area Under the Ulocuplumab Concentration-time Curve From Time Zero to Infinity [AUC(INF)] - Phases 1 and 2 [Days 1, 8, 15 for cycles 1 and 2; Days 1, 8 for cycles 3-5; Day 1 every 4th cycle thereafter; EOT; 30 days post last dose (follow-up)]
The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration. EOT = end of treatment AUC(INF) calculated by summing AUC(0-T) and the extrapolated area, computed by the quotient Clast/λz Measure type and method of dispersion are Geometric mean and %CV, respectively
- Elimination Half-life (T-HALF) - Phases 1 and 2 [Days 1, 8, 15 for cycles 1 and 2; Days 1, 8 for cycles 3-5; Day 1 every 4th cycle thereafter; EOT; 30 days post last dose (follow-up)]
The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration. EOT = end of treatment T-HALF determined as 0.693/λz
- Total Body Clearance of Ulocuplumab (CLT) - Phases 1 and 2 [Days 1, 8, 15 for cycles 1 and 2; Days 1, 8 for cycles 3-5; Day 1 every 4th cycle thereafter; EOT; 30 days post last dose (follow-up)]
The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration. EOT = end of treatment CLT calculated by dividing the total dose of ulocuplumab by its corresponding AUC(INF) value Measure type and method of dispersion are Geometric mean and %CV, respectively
- Volume of Distribution at Steady State (Vss) - Phases 1 and 2 [Days 1, 8, 15 for cycles 1 and 2; Days 1, 8 for cycles 3-5; Day 1 every 4th cycle thereafter; EOT; 30 days post last dose (follow-up)]
The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration. EOT = end of treatment Measure type and method of dispersion are Geometric mean and %CV, respectively
- Overall Rate of Remission in Participants Treated With Ulocuplumab at Two Different Dose Levels 800 mg and 1000 mg in Combination With LDAC - Phase 2 [From first dose until a minimum follow-up of up to 2 months]
This phase 2 secondary endpoint was based on the rate of Overall Remission (OR=PR+CR +CRi) prior to the initiation of any alternative therapy (including any subsequent ulocuplumab 800 mg for participants in the LDAC alone arm). The phase 2 analysis was conducted after all participants had an opportunity for 6 months of follow-up. Overall remission rate: CR + CRi, + PR confidence interval based on the Clopper and Pearson method. CR = complete response CRi = complete response, incomplete blood count PR = partial remission
- Duration of Response in Participants With CR/CRi Treated With Ulocuplumab at Two Different Dose Levels 800 mg and 1000 mg in Combination With LDAC - Phase 2 [From first dose until a minimum follow-up of up to 2 months]
This phase 2 secondary endpoint was based on the duration of complete remission prior to the initiation of any alternative therapy (including any subsequent ulocuplumab 800 mg for participants in the LDAC alone arm). The phase 2 analysis was conducted after all participants had an opportunity for 6 months of follow-up.
- Rate of Complete Remission (CR/CRi) and Overall Rate of Remission in Participants Treated With LDAC Only - Phase 2 [From first dose until a minimum follow-up of up to 2 months]
This phase 2 secondary endpoint was based on the rate of Complete Remission (CR/CRi) and rate of Overall Remission (OR=PR+CR +CRi) prior to the initiation of any alternative therapy (including any subsequent ulocuplumab 800 mg for participants in the LDAC alone arm). The phase 2 analysis was conducted after all participants had an opportunity for 6 months of follow-up. Overall remission rate: CR + CRi, + PR confidence interval based on the Clopper and Pearson method. CR = complete response CRi = complete response, incomplete blood count PR = partial remission
- Duration of Response in Participants With CR/CRi Treated With LDAC Only - Phase 2 [From first dose until a minimum follow-up of up to 2 months]
This phase 2 secondary endpoint was based on the duration of complete remission prior to the initiation of any alternative therapy (including any subsequent ulocuplumab 800 mg for participants in the LDAC alone arm). The phase 2 analysis was conducted after all participants had an opportunity for 6 months of follow-up.
- Change From Baseline of Electrocardiogram (ECG) Endpoints: Heart Rate - Phases 1 and 2 [From first dose until a minimum follow-up of up to 2 months]
Change from baseline of ECG endpoints Heart rate measured in beats per minute (bpm)
- Change From Baseline of Electrocardiogram (ECG) Endpoints: PR Interval - Phases 1 and 2 [From first dose until a minimum follow-up of up to 2 months]
Change from baseline of ECG endpoints PR interval measured in milliseconds (msec)
- Change From Baseline of Electrocardiogram (ECG) Endpoints: QRS Interval - Phases 1 and 2 [From first dose until a minimum follow-up of up to 2 months]
Change from baseline of ECG endpoints QRS interval measured in milliseconds (msec)
- Change From Baseline of Electrocardiogram (ECG) Endpoints: QT Interval - Phases 1 and 2 [From first dose until a minimum follow-up of up to 2 months]
Change from baseline of ECG endpoints QT interval measured in milliseconds (msec)
- Overall Survival (OS) - Phases 1 and 2 [From first dose until a minimum follow-up of up to 2 months]
OS is defined as the time between the first date of treatment and the date of death due to any cause. A participant who has not died was be censored at the last known alive date.
Eligibility Criteria
Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
-
Newly Diagnosed Acute Myeloid Leukemia (AML)
-
Considered inappropriate for intensive remission induction therapy by an investigator
-
Not eligible for stem cell transplantation
Exclusion Criteria:
-
Acute promyelocytic leukemia
-
Current Myelodysplastic syndrome only subjects
-
Unstable angina or uncontrolled congestive heart failure
-
Any other malignancy, excluding basal or squamous cell carcinoma of the skin, in situ melanoma, cervical carcinoma in situ, localized prostate cancer, or superficial bladder cancer stage 0, from which the subject has not been disease-free for at least 3 years
-
Respiratory disease requiring continuous supplemental oxygen
Other protocol defined inclusion/exclusion criteria could apply
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Ucla Center Health Sci | Los Angeles | California | United States | 90095-3075 |
2 | UF Health Cancer Center at Orlando Health | Orlando | Florida | United States | 32806 |
3 | Norton Cancer Institute | Louisville | Kentucky | United States | 40207 |
4 | NYU Langone Medical Center | New York | New York | United States | 10016 |
5 | Duke University Adult Bone Marrow Transplant Clinic | Durham | North Carolina | United States | 27705 |
6 | University Of Cincinnati | Cincinnati | Ohio | United States | 45219 |
7 | Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | United States | 44195 |
8 | The University Of Texas MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
9 | Froedtert Hospital & Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
10 | Liga Paranaense De Combate Ao Cancer Erasto Gaertner | Curitiba | Parana | Brazil | 81520-060 |
11 | Instituto Do Cancer Mae De Deus / Cor Hospital Mae De Deus | Porto Alegre | RIO Grande DO SUL | Brazil | 90110-270 |
12 | Fundacao Pio Xii Hosp Cancer De Barretos | Barretos | Sao Paulo | Brazil | 14784-400 |
13 | IEP Sao Lucas | Sao Paulo | Brazil | 01236-030 | |
14 | Local Institution | Sao Paulo | Brazil | 01246-000 | |
15 | Local Institution | Sao Paulo | Brazil | 05651-901 | |
16 | Local Institution | Halifax | Nova Scotia | Canada | B3H 2Y9 |
17 | Local Institution | Hong Kong | China | ||
18 | Local Institution | Jerusalem | Israel | 91031 | |
19 | Local Institution | Tel Aviv | Israel | 94239 | |
20 | Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele | Catania | Italy | 95123 | |
21 | Local Institution | Milan | Italy | 20162 | |
22 | Azienda Ospedaliera Di Rilievo Nazionale A. Cardarelli | Napoli | Italy | 80131 | |
23 | Local Institution | Roma | Italy | 00133 | |
24 | Local Institution | Nagoya-shi | Aichi | Japan | 4600001 |
25 | Local Institution | Fukuyama-shi | Hiroshima | Japan | 7200001 |
26 | Local Institution | Isehara | Kanagawa | Japan | 2591193 |
27 | Local Institution | Hirakata-shi | Osaka | Japan | 5731191 |
28 | Local Institution | Bunkyo-ku | Tokyo | Japan | 1138677 |
29 | Local Institution | Shinagawa-ku | Tokyo | Japan | 1418625 |
30 | Local Institution | Shinjuku-Ku | Tokyo | Japan | 1608582 |
31 | Local Institution | Tachikawa | Tokyo | Japan | 1900014 |
32 | Local Institution | Seoul | Korea, Republic of | 06351 | |
33 | Local Institution | Seoul | Korea, Republic of | 06591 | |
34 | Local Institution | Bucharest | Romania | 020125 | |
35 | Local Institution | Kaohsiung | Taiwan | 833 | |
36 | Local Institution | New Taipei City | Taiwan | 235 | |
37 | Local Institution | New Taipei City | Taiwan | 25173 | |
38 | Local Institution | Taoyuan City | Taiwan | 33305 |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- CA212-016
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail | 6 participants in Phase 1 and 64 participants in Phase 2 (70 in total) were assigned to treatment. 2 participants randomized to the LDAC-only arm in Phase 2 did not receive treatment. 68 participants in total (phases 1 and 2) were treated. |
Arm/Group Title | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 | LDAC - Ph2 |
---|---|---|---|---|---|
Arm/Group Description | Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission |
Period Title: Treatment Period | |||||
STARTED | 3 | 3 | 26 | 14 | 24 |
COMPLETED | 1 | 1 | 0 | 0 | 0 |
NOT COMPLETED | 2 | 2 | 26 | 14 | 24 |
Period Title: Treatment Period | |||||
STARTED | 3 | 3 | 11 | 6 | 12 |
COMPLETED | 0 | 0 | 0 | 0 | 0 |
NOT COMPLETED | 3 | 3 | 11 | 6 | 12 |
Baseline Characteristics
Arm/Group Title | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 | LDAC - Ph2 | Total |
---|---|---|---|---|---|---|
Arm/Group Description | Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission | Total of all reporting groups |
Overall Participants | 3 | 3 | 26 | 14 | 24 | 70 |
Age (Years) [Mean (Standard Deviation) ] | ||||||
Mean (Standard Deviation) [Years] |
73.7
(8.02)
|
77.3
(1.53)
|
74.9
(5.4)
|
73.1
(3.7)
|
75.9
(5.7)
|
74.9
(5.21)
|
Age, Customized (Number) [Number] | ||||||
<70 |
1
33.3%
|
0
0%
|
4
15.4%
|
3
21.4%
|
3
12.5%
|
11
15.7%
|
>=70 |
2
66.7%
|
3
100%
|
22
84.6%
|
11
78.6%
|
21
87.5%
|
59
84.3%
|
Sex: Female, Male (Count of Participants) | ||||||
Female |
3
100%
|
0
0%
|
9
34.6%
|
7
50%
|
14
58.3%
|
33
47.1%
|
Male |
0
0%
|
3
100%
|
17
65.4%
|
7
50%
|
10
41.7%
|
37
52.9%
|
Ethnicity (NIH/OMB) (Count of Participants) | ||||||
Hispanic or Latino |
0
0%
|
|||||
Not Hispanic or Latino |
0
0%
|
|||||
Unknown or Not Reported |
0
0%
|
|||||
Race/Ethnicity, Customized (Count of Participants) | ||||||
White |
0
0%
|
0
0%
|
15
57.7%
|
4
28.6%
|
12
50%
|
31
44.3%
|
Black/African American |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Japanese |
3
100%
|
3
100%
|
6
23.1%
|
6
42.9%
|
4
16.7%
|
22
31.4%
|
Chinese |
0
0%
|
0
0%
|
2
7.7%
|
2
14.3%
|
3
12.5%
|
7
10%
|
Asian Indian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Asian Other |
0
0%
|
0
0%
|
3
11.5%
|
0
0%
|
2
8.3%
|
5
7.1%
|
American Indian/Alaskan Native |
0
0%
|
0
0%
|
0
0%
|
1
7.1%
|
0
0%
|
1
1.4%
|
Native Hawaiian/Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Other |
0
0%
|
0
0%
|
0
0%
|
1
7.1%
|
3
12.5%
|
4
5.7%
|
Outcome Measures
Title | Number of Participants With Dose-Limiting Toxicities (DLTs) in Treatment Cycle 1 - Phase 1 |
---|---|
Description | Safety data evaluated for DLTs. DLTs and all other toxicities were defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03). DLTs were defined based upon events that were considered to be related to ulocuplumab in combination with LDAC and that occurred during the first cycle of drug administration (28 days). |
Time Frame | From first dose to end of cycle 1 (28 days) |
Outcome Measure Data
Analysis Population Description |
---|
All treated participants |
Arm/Group Title | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 |
---|---|---|
Arm/Group Description | Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) |
Measure Participants | 3 | 3 |
Number [Participants] |
0
0%
|
0
0%
|
Title | Number of Participants With Adverse Events (AEs) - Phase 1 |
---|---|
Description | The number of participants with an on-study adverse event (AE). Safety data are evaluated for AEs, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03). |
Time Frame | From first dose to 30 days post last dose |
Outcome Measure Data
Analysis Population Description |
---|
All treated participants |
Arm/Group Title | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 |
---|---|---|
Arm/Group Description | Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) |
Measure Participants | 3 | 3 |
Number [Participants] |
3
100%
|
3
100%
|
Title | Number of Participants With >= Grade 3 AEs - Phase 1 |
---|---|
Description | The number of participants with an on-study adverse event >= Grade level 3. Safety data are evaluated for >= Grade 3 AEs, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03). |
Time Frame | From first dose to 30 days post last dose |
Outcome Measure Data
Analysis Population Description |
---|
All treated participants |
Arm/Group Title | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 |
---|---|---|
Arm/Group Description | Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) |
Measure Participants | 3 | 3 |
Number [Participants] |
3
100%
|
3
100%
|
Title | Number of Participants With AEs Leading to Discontinuation - Phase 1 |
---|---|
Description | The number of participants with an on-study adverse event (AE) leading to discontinuation. Safety data are evaluated for AEs leading to discontinuation, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03). |
Time Frame | From first dose to 30 days post last dose |
Outcome Measure Data
Analysis Population Description |
---|
All treated participants |
Arm/Group Title | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 |
---|---|---|
Arm/Group Description | Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) |
Measure Participants | 3 | 3 |
Number [Participants] |
0
0%
|
0
0%
|
Title | Number of Participants With Serious Adverse Events (SAEs) - Phase 1 |
---|---|
Description | The number of participants with an on-study serious adverse event (SAE). Safety data are evaluated for SAEs, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03). |
Time Frame | From first dose to 30 days post last dose |
Outcome Measure Data
Analysis Population Description |
---|
All treated participants |
Arm/Group Title | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 |
---|---|---|
Arm/Group Description | Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) |
Measure Participants | 3 | 3 |
Number [Participants] |
2
66.7%
|
1
33.3%
|
Title | Number of Deaths - Phase 1 |
---|---|
Description | The number of participants who died. |
Time Frame | From first dose to 30 days post last dose |
Outcome Measure Data
Analysis Population Description |
---|
All treated participants |
Arm/Group Title | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 |
---|---|---|
Arm/Group Description | Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) |
Measure Participants | 3 | 3 |
Number [Participants] |
0
0%
|
0
0%
|
Title | Number of Participants With Laboratory Abnormalities - Phase 1 |
---|---|
Description | The number of participants with an on-study laboratory abnormality. Safety data are evaluated for laboratory abnormalities, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03). grades 1, 2, 3, 4, 5, unknown, with 5 being the worst outcome |
Time Frame | From first dose to 30 days post last dose |
Outcome Measure Data
Analysis Population Description |
---|
All treated participants |
Arm/Group Title | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 |
---|---|---|
Arm/Group Description | Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) |
Measure Participants | 3 | 3 |
ABSOLUTE NEUTROPHIL COUNT - grade 3 |
0
0%
|
1
33.3%
|
ABSOLUTE NEUTROPHIL COUNT - grade 4 |
3
100%
|
2
66.7%
|
ALANINE AMINOTRANSFERASE - grade 0 |
2
66.7%
|
2
66.7%
|
ALANINE AMINOTRANSFERASE - grade 1 |
1
33.3%
|
1
33.3%
|
ALBUMIN - grade 0 |
1
33.3%
|
0
0%
|
ALBUMIN - grade 1 |
0
0%
|
2
66.7%
|
ALBUMIN - grade 2 |
2
66.7%
|
1
33.3%
|
ALKALINE PHOSPHATASE - grade 0 |
2
66.7%
|
2
66.7%
|
ALKALINE PHOSPHATASE grade 1 |
1
33.3%
|
1
33.3%
|
ASPARTATE AMINOTRANSFERASE - grade 0 |
3
100%
|
2
66.7%
|
ASPARTATE AMINOTRANSFERASE - grade 1 |
0
0%
|
1
33.3%
|
BILIRUBIN, TOTAL - grade 0 |
3
100%
|
2
66.7%
|
BILIRUBIN, TOTAL - grade 2 |
0
0%
|
1
33.3%
|
CALCIUM, TOTAL - grade 0 |
1
33.3%
|
1
33.3%
|
CALCIUM, TOTAL - grade 1 |
0
0%
|
1
33.3%
|
CALCIUM, TOTAL - grade 2 |
2
66.7%
|
1
33.3%
|
CREATINE KINASE - grade 0 |
3
100%
|
3
100%
|
CREATININE - grade 0 |
2
66.7%
|
3
100%
|
CREATININE - grade 1 |
1
33.3%
|
0
0%
|
FIBRINOGEN - grade 0 |
1
33.3%
|
0
0%
|
GLUCOSE, FASTING SERUM - grade 0 |
1
33.3%
|
1
33.3%
|
GLUCOSE, FASTING SERUM - grade 1 |
2
66.7%
|
0
0%
|
GLUCOSE, FASTING SERUM - grade 2 |
0
0%
|
2
66.7%
|
HEMOGLOBIN - grade 2 |
1
33.3%
|
1
33.3%
|
HEMOGLOBIN - grade 3 |
2
66.7%
|
2
66.7%
|
LEUKOCYTES - grade 0 |
0
0%
|
1
33.3%
|
LEUKOCYTES - grade 3 |
1
33.3%
|
1
33.3%
|
LEUKOCYTES - grade 4 |
2
66.7%
|
1
33.3%
|
LIPASE, TOTAL (COLORIMETRIC ASSAY) - grade 0 |
2
66.7%
|
1
33.3%
|
LIPASE, TOTAL (COLORIMETRIC ASSAY) - grade 1 |
1
33.3%
|
0
0%
|
LIPASE, TOTAL (COLORIMETRIC ASSAY) - grade 3 |
0
0%
|
2
66.7%
|
LYMPHOCYTES (ABSOLUTE) - grade 0 |
0
0%
|
1
33.3%
|
LYMPHOCYTES (ABSOLUTE) - grade 1 |
0
0%
|
1
33.3%
|
LYMPHOCYTES (ABSOLUTE) - grade 2 |
2
66.7%
|
1
33.3%
|
LYMPHOCYTES (ABSOLUTE) - grade 3 |
1
33.3%
|
0
0%
|
NEUTROPHILS (ABSOLUTE) - grade 3 |
0
0%
|
1
33.3%
|
NEUTROPHILS (ABSOLUTE) - grade 4 |
3
100%
|
2
66.7%
|
PHOSPHORUS, INORGANIC - grade 0 |
3
100%
|
2
66.7%
|
PHOSPHORUS, INORGANIC - grade 3 |
0
0%
|
1
33.3%
|
PLATELET COUNT - grade 3 |
0
0%
|
1
33.3%
|
PLATELET COUNT - grade 4 |
3
100%
|
2
66.7%
|
POTASSIUM, SERUM - grade 0 |
1
33.3%
|
2
66.7%
|
POTASSIUM, SERUM - grade 1 |
0
0%
|
1
33.3%
|
POTASSIUM, SERUM - grade 3 |
2
66.7%
|
0
0%
|
SODIUM, SERUM - grade 0 |
2
66.7%
|
1
33.3%
|
SODIUM, SERUM - grade 1 |
0
0%
|
2
66.7%
|
SODIUM, SERUM - grade 3 |
1
33.3%
|
0
0%
|
URIC ACID - grade 0 |
3
100%
|
2
66.7%
|
URIC ACID - grade 1 |
0
0%
|
1
33.3%
|
Title | Best Overall Response (BOR) - Phase 2 |
---|---|
Description | The phase 2 primary endpoint was based on the rate of Complete Remission (CR/CRi) prior to the initiation of any alternative therapy (including any subsequent ulocuplumab 800 mg for participants in the LDAC alone arm). The phase 2 primary analysis was conducted after all participants had an opportunity for 6 months of follow-up. Complete remission rate: CR + CRi, confidence interval based on the Clopper and Pearson method. CR = complete response CRi = complete response, incomplete blood count |
Time Frame | From first dose until a minimum follow-up of up to 2 months |
Outcome Measure Data
Analysis Population Description |
---|
All randomized participants |
Arm/Group Title | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 | LDAC - Ph2 |
---|---|---|---|
Arm/Group Description | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission |
Measure Participants | 26 | 14 | 24 |
Number (95% Confidence Interval) [Percentage of participants] |
15.4
513.3%
|
7.1
236.7%
|
25.0
96.2%
|
Title | Best Overall Response (BOR) - Phase 1 |
---|---|
Description | Investigator assessed best overall response prior to the initiation of any alternative therapy for Phase 1 participants. |
Time Frame | From first dose until a minimum follow-up of up to 2 months |
Outcome Measure Data
Analysis Population Description |
---|
All randomized participants |
Arm/Group Title | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 |
---|---|---|
Arm/Group Description | Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) |
Measure Participants | 3 | 3 |
Number [Participants] |
1
33.3%
|
3
100%
|
Title | Number of Participants With AEs - Phase 2 |
---|---|
Description | The number of participants with an on-study adverse event (AE). Safety data are evaluated for AEs, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03). |
Time Frame | From first dose until a minimum follow-up of up to 2 months |
Outcome Measure Data
Analysis Population Description |
---|
All treated participants |
Arm/Group Title | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 | LDAC - Ph2 |
---|---|---|---|
Arm/Group Description | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission |
Measure Participants | 26 | 14 | 22 |
Number [Participants] |
25
833.3%
|
14
466.7%
|
22
84.6%
|
Title | Number of Participants With AEs Leading to Discontinuation - Phase 2 |
---|---|
Description | The number of participants with an on-study adverse event (AE) leading to discontinuation. Safety data are evaluated for AEs leading to discontinuation, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03). |
Time Frame | From first dose until a minimum follow-up of up to 2 months |
Outcome Measure Data
Analysis Population Description |
---|
All treated participants |
Arm/Group Title | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 | LDAC - Ph2 |
---|---|---|---|
Arm/Group Description | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission |
Measure Participants | 26 | 14 | 22 |
Number [Participants] |
7
233.3%
|
3
100%
|
4
15.4%
|
Title | Number of Participants With SAEs - Phase 2 |
---|---|
Description | The number of participants with an on-study serious adverse event (SAE). Safety data are evaluated for SAEs, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03). |
Time Frame | From first dose until a minimum follow-up of up to 2 months |
Outcome Measure Data
Analysis Population Description |
---|
All treated participants |
Arm/Group Title | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 | LDAC - Ph2 |
---|---|---|---|
Arm/Group Description | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission |
Measure Participants | 26 | 14 | 22 |
Number [Participants] |
21
700%
|
8
266.7%
|
15
57.7%
|
Title | Number of Deaths- Phase 2 |
---|---|
Description | The number of participants who died. Safety data are evaluated for deaths, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03). |
Time Frame | From first dose until a minimum follow-up of up to 2 months |
Outcome Measure Data
Analysis Population Description |
---|
All treated participants |
Arm/Group Title | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 | LDAC - Ph2 |
---|---|---|---|
Arm/Group Description | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission |
Measure Participants | 26 | 14 | 22 |
Number [Participants] |
19
633.3%
|
10
333.3%
|
16
61.5%
|
Title | Number of Participants With Laboratory Abnormalities - Phase 2 |
---|---|
Description | The number of participants with an on-study laboratory abnormality, assessed from Grade 1-4 Serum Chemistry, Electrolytes, and Hematology Laboratory Test results, with grade 4 being the worst. Safety data are evaluated for laboratory abnormalities, defined and evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03). |
Time Frame | From first dose until a minimum follow-up of up to 2 months |
Outcome Measure Data
Analysis Population Description |
---|
All treated participants |
Arm/Group Title | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 | LDAC - Ph2 |
---|---|---|---|
Arm/Group Description | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission |
Measure Participants | 26 | 14 | 22 |
ALANINE AMINOTRANSFERASE (ALT), grade 1 |
5
166.7%
|
5
166.7%
|
4
15.4%
|
ALANINE AMINOTRANSFERASE (ALT), grade 2 |
0
0%
|
1
33.3%
|
2
7.7%
|
ALANINE AMINOTRANSFERASE (ALT), grade 3 |
2
66.7%
|
2
66.7%
|
0
0%
|
ALKALINE PHOSPHATASE (ALP), grade 1 |
9
300%
|
3
100%
|
8
30.8%
|
ALKALINE PHOSPHATASE (ALP), grade 2 |
1
33.3%
|
5
166.7%
|
2
7.7%
|
ASPARTATE AMINOTRANSFERASE (AST), grade 1 |
7
233.3%
|
8
266.7%
|
4
15.4%
|
ASPARTATE AMINOTRANSFERASE (AST), grade 2 |
1
33.3%
|
0
0%
|
2
7.7%
|
ASPARTATE AMINOTRANSFERASE (AST), grade 3 |
0
0%
|
1
33.3%
|
0
0%
|
BILIRUBIN, TOTAL, grade 1 |
3
100%
|
2
66.7%
|
1
3.8%
|
BILIRUBIN, TOTAL, grade 2 |
4
133.3%
|
3
100%
|
1
3.8%
|
BILIRUBIN, TOTAL, grade 3 |
1
33.3%
|
0
0%
|
0
0%
|
CREATININE, grade 1 |
7
233.3%
|
5
166.7%
|
6
23.1%
|
CREATININE, grade 2 |
5
166.7%
|
2
66.7%
|
2
7.7%
|
CALCIUM, TOTAL, grade 1 |
7
233.3%
|
3
100%
|
3
11.5%
|
CALCIUM, TOTAL, grade 2 |
5
166.7%
|
5
166.7%
|
7
26.9%
|
CALCIUM, TOTAL, grade 3 |
0
0%
|
1
33.3%
|
0
0%
|
PHOSPHORUS, INORGANIC, grade 1 |
0
0%
|
0
0%
|
1
3.8%
|
PHOSPHORUS, INORGANIC, grade 2 |
3
100%
|
2
66.7%
|
1
3.8%
|
PHOSPHORUS, INORGANIC, grade 3 |
2
66.7%
|
0
0%
|
2
7.7%
|
PHOSPHORUS, INORGANIC, grade 4 |
0
0%
|
1
33.3%
|
0
0%
|
POTASSIUM, SERUM, grade 1 |
4
133.3%
|
3
100%
|
5
19.2%
|
POTASSIUM, SERUM, grade 2 |
0
0%
|
1
33.3%
|
0
0%
|
POTASSIUM, SERUM, grade 3 |
1
33.3%
|
2
66.7%
|
4
15.4%
|
POTASSIUM, SERUM, grade 4 |
1
33.3%
|
1
33.3%
|
0
0%
|
SODIUM, SERUM, grade 1 |
9
300%
|
3
100%
|
7
26.9%
|
SODIUM, SERUM, grade 2 |
0
0%
|
1
33.3%
|
0
0%
|
SODIUM, SERUM, grade 3 |
0
0%
|
3
100%
|
4
15.4%
|
HEMOGLOBIN, grade 2 |
2
66.7%
|
4
133.3%
|
4
15.4%
|
HEMOGLOBIN, grade 3 |
22
733.3%
|
10
333.3%
|
17
65.4%
|
PLATELET COUNT, grade 2 |
0
0%
|
0
0%
|
1
3.8%
|
PLATELET COUNT, grade 3 |
1
33.3%
|
1
33.3%
|
3
11.5%
|
PLATELET COUNT, grade 4 |
23
766.7%
|
13
433.3%
|
17
65.4%
|
ABSOLUTE NEUTROPHIL COUNT, grade 1 |
2
66.7%
|
1
33.3%
|
0
0%
|
ABSOLUTE NEUTROPHIL COUNT, grade 2 |
0
0%
|
1
33.3%
|
1
3.8%
|
ABSOLUTE NEUTROPHIL COUNT, grade 3 |
3
100%
|
0
0%
|
1
3.8%
|
ABSOLUTE NEUTROPHIL COUNT, grade 4 |
18
600%
|
10
333.3%
|
16
61.5%
|
LEUKOCYTES, grade 1 |
3
100%
|
0
0%
|
1
3.8%
|
LEUKOCYTES, grade 2 |
3
100%
|
4
133.3%
|
0
0%
|
LEUKOCYTES, grade 3 |
6
200%
|
4
133.3%
|
5
19.2%
|
LEUKOCYTES, grade 4 |
8
266.7%
|
1
33.3%
|
10
38.5%
|
LYMPHOCYTES (ABSOLUTE), grade 1 |
3
100%
|
4
133.3%
|
1
3.8%
|
LYMPHOCYTES (ABSOLUTE), grade 2 |
7
233.3%
|
1
33.3%
|
7
26.9%
|
LYMPHOCYTES (ABSOLUTE), grade 3 |
5
166.7%
|
0
0%
|
7
26.9%
|
LYMPHOCYTES (ABSOLUTE), grade 4 |
0
0%
|
0
0%
|
1
3.8%
|
NEUTROPHILS (ABSOLUTE), grade 1 |
1
33.3%
|
0
0%
|
0
0%
|
NEUTROPHILS (ABSOLUTE), grade 2 |
1
33.3%
|
2
66.7%
|
1
3.8%
|
NEUTROPHILS (ABSOLUTE), grade 3 |
3
100%
|
0
0%
|
1
3.8%
|
NEUTROPHILS (ABSOLUTE), grade 4 |
18
600%
|
10
333.3%
|
16
61.5%
|
Title | Number of Participants With Anti-drug Antibodies (ADA) Positive for Ulocuplumab - Phases 1 and 2 |
---|---|
Description | Serum samples from ulocuplumab treated participants were evaluated for the presence of anti-ulocuplumab antibodies |
Time Frame | From first dose until a minimum follow-up of up to 2 months |
Outcome Measure Data
Analysis Population Description |
---|
All participants treated with ulocuplumab |
Arm/Group Title | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 |
---|---|---|---|---|
Arm/Group Description | Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) |
Measure Participants | 3 | 3 | 21 | 14 |
Number [Participants] |
0
0%
|
0
0%
|
6
23.1%
|
0
0%
|
Title | Maximum Observed Serum Concentration (Cmax) - Phases 1 and 2 |
---|---|
Description | The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration EOT = end of treatment Measure type and method of dispersion are Geometric mean and %CV, respectively |
Time Frame | Cycle 1 Day 1 |
Outcome Measure Data
Analysis Population Description |
---|
All treated participants who have evaluable PK profiles |
Arm/Group Title | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 | LDAC - Ph2 |
---|---|---|---|---|---|
Arm/Group Description | Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission |
Measure Participants | 3 | 3 | 17 | 14 | 1 |
Geometric Mean (Geometric Coefficient of Variation) [µg/mL] |
219.354
(19)
|
265.294
(8)
|
183.456
(25)
|
256.906
(22)
|
212.564
(NA)
|
Title | Trough Observed Serum Concentration (Ctrough) - Phases 1 and 2 |
---|---|
Description | The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration. EOT = end of treatment Measure type and method of dispersion are Geometric mean and %CV, respectively |
Time Frame | Days 1, 8, 15 for cycle 1; Days 8, 15 for cycle 2; Days 1, 8 for cycles 3-5; Day 1 every 4th cycle thereafter; EOT; 30 days post last dose (follow-up) |
Outcome Measure Data
Analysis Population Description |
---|
All treated participants who have evaluable PK profiles |
Arm/Group Title | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 | LDAC - Ph2 |
---|---|---|---|---|---|
Arm/Group Description | Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission |
Measure Participants | 3 | 3 | 22 | 13 | 1 |
Cycle 1 Day 1 |
0.100
(0)
|
0.100
(0)
|
0.100
(0)
|
0.100
(0)
|
0.100
(NA)
|
Cycle 1 Day 8 |
5.308
(89)
|
75.890
(30)
|
10.321
(85)
|
17.766
(79)
|
39.609
(NA)
|
Cycle 1 Day 15 |
21.748
(91)
|
125.797
(18)
|
37.263
(66)
|
61.250
(64)
|
175.315
(NA)
|
Cycle 2 Day 8 |
41.630
(NA)
|
96.333
(36)
|
30.916
(83)
|
103.322
(67)
|
|
Cycle 2 Day 15 |
72.104
(NA)
|
126.029
(49)
|
48.421
(73)
|
143.724
(58)
|
|
Cycle 3 Day 1 |
78.218
(NA)
|
13.905
(101)
|
153.871
(70)
|
||
Cycle 3 Day 8 |
85.993
(NA)
|
129.580
(42)
|
37.602
(94)
|
82.033
(21)
|
|
Cycle 4 Day 1 |
80.409
(64)
|
4.012
(145)
|
212.793
(NA)
|
||
Cycle 4 Day 8 |
112.048
(NA)
|
133.650
(41)
|
116.657
(83)
|
77.095
(119)
|
|
Cycle 5 Day 1 |
32.621
(NA)
|
4.558
(166)
|
224.703
(NA)
|
||
Cycle 5 Day 8 |
102.751
(NA)
|
124.996
(48)
|
34.783
(137)
|
202.552
(NA)
|
|
Cycle 9 Day 1 |
35.144
(110)
|
187.930
(NA)
|
|||
EOT |
0.100
(NA)
|
Title | Time of Maximum Observed Ulocuplumab Serum Concentration (Tmax) - Phases 1 and 2 |
---|---|
Description | The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration. EOT = end of treatment |
Time Frame | Cycle 1 Day 1 |
Outcome Measure Data
Analysis Population Description |
---|
All treated participants who have evaluable PK profiles |
Arm/Group Title | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 | LDAC - Ph2 |
---|---|---|---|---|---|
Arm/Group Description | Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission |
Measure Participants | 3 | 3 | 17 | 7 | 1 |
Median (Full Range) [hour (H)] |
1.850
|
1.933
|
1.500
|
2.117
|
2.03
|
Title | Area Under the Ulocuplumab Concentration-time Curve From Time Zero to the Last Quantifiable Concentration [AUC(0-T)] - Phases 1 and 2 |
---|---|
Description | The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration. EOT = end of treatment AUC(0-T) calculated by log- and linear-trapezoidal summation Measure type and method of dispersion are Geometric mean and %CV, respectively |
Time Frame | Cycle 1 Day 1 |
Outcome Measure Data
Analysis Population Description |
---|
All treated participants who have evaluable PK profiles |
Arm/Group Title | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 | LDAC - Ph2 |
---|---|---|---|---|---|
Arm/Group Description | Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission |
Measure Participants | 3 | 3 | 17 | 7 | 1 |
Geometric Mean (Geometric Coefficient of Variation) [µg.h/mL] |
9455.529
(10)
|
21158.725
(9)
|
8152.698
(50)
|
13744.382
(37)
|
16502.463
(NA)
|
Title | Area Under the Ulocuplumab Concentration-time Curve in One Dosing Interval [AUC(TAU)] - Phases 1 and 2 |
---|---|
Description | The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration. EOT = end of treatment Measure type and method of dispersion are Geometric mean and %CV, respectively |
Time Frame | Cycle 1 Day 1 |
Outcome Measure Data
Analysis Population Description |
---|
All treated participants who have evaluable PK profiles |
Arm/Group Title | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 | LDAC - Ph2 |
---|---|---|---|---|---|
Arm/Group Description | Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission |
Measure Participants | 3 | 3 | 13 | 7 | 1 |
Geometric Mean (Geometric Coefficient of Variation) [µg.h/mL] |
9455.529
(10)
|
21158.725
(9)
|
10082.624
(38)
|
13826.833
(36)
|
14257.807
(NA)
|
Title | Area Under the Ulocuplumab Concentration-time Curve From Time Zero to Infinity [AUC(INF)] - Phases 1 and 2 |
---|---|
Description | The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration. EOT = end of treatment AUC(INF) calculated by summing AUC(0-T) and the extrapolated area, computed by the quotient Clast/λz Measure type and method of dispersion are Geometric mean and %CV, respectively |
Time Frame | Days 1, 8, 15 for cycles 1 and 2; Days 1, 8 for cycles 3-5; Day 1 every 4th cycle thereafter; EOT; 30 days post last dose (follow-up) |
Outcome Measure Data
Analysis Population Description |
---|
Based on the PK sample collections, PK parameters depended on terminal phase time points including AUC(INF), T-HALF; or at steady-state, including CLT, Vss are not reportable |
Arm/Group Title | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 | LDAC - Ph2 |
---|---|---|---|---|---|
Arm/Group Description | Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission |
Measure Participants | 0 | 0 | 0 | 0 | 0 |
Title | Elimination Half-life (T-HALF) - Phases 1 and 2 |
---|---|
Description | The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration. EOT = end of treatment T-HALF determined as 0.693/λz |
Time Frame | Days 1, 8, 15 for cycles 1 and 2; Days 1, 8 for cycles 3-5; Day 1 every 4th cycle thereafter; EOT; 30 days post last dose (follow-up) |
Outcome Measure Data
Analysis Population Description |
---|
Based on the PK sample collections, PK parameters depended on terminal phase time points including AUC(INF), T-HALF; or at steady-state, including CLT, Vss are not reportable |
Arm/Group Title | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 | LDAC - Ph2 |
---|---|---|---|---|---|
Arm/Group Description | Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission |
Measure Participants | 0 | 0 | 0 | 0 | 0 |
Title | Total Body Clearance of Ulocuplumab (CLT) - Phases 1 and 2 |
---|---|
Description | The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration. EOT = end of treatment CLT calculated by dividing the total dose of ulocuplumab by its corresponding AUC(INF) value Measure type and method of dispersion are Geometric mean and %CV, respectively |
Time Frame | Days 1, 8, 15 for cycles 1 and 2; Days 1, 8 for cycles 3-5; Day 1 every 4th cycle thereafter; EOT; 30 days post last dose (follow-up) |
Outcome Measure Data
Analysis Population Description |
---|
Based on the PK sample collections, PK parameters depended on terminal phase time points including AUC(INF), T-HALF; or at steady-state, including CLT, Vss are not reportable |
Arm/Group Title | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 | LDAC - Ph2 |
---|---|---|---|---|---|
Arm/Group Description | Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission |
Measure Participants | 0 | 0 | 0 | 0 | 0 |
Title | Volume of Distribution at Steady State (Vss) - Phases 1 and 2 |
---|---|
Description | The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration. EOT = end of treatment Measure type and method of dispersion are Geometric mean and %CV, respectively |
Time Frame | Days 1, 8, 15 for cycles 1 and 2; Days 1, 8 for cycles 3-5; Day 1 every 4th cycle thereafter; EOT; 30 days post last dose (follow-up) |
Outcome Measure Data
Analysis Population Description |
---|
Based on the PK sample collections, PK parameters depended on terminal phase time points including AUC(INF), T-HALF; or at steady-state, including CLT, Vss are not reportable |
Arm/Group Title | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 | LDAC - Ph2 |
---|---|---|---|---|---|
Arm/Group Description | Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission |
Measure Participants | 0 | 0 | 0 | 0 | 0 |
Title | Overall Rate of Remission in Participants Treated With Ulocuplumab at Two Different Dose Levels 800 mg and 1000 mg in Combination With LDAC - Phase 2 |
---|---|
Description | This phase 2 secondary endpoint was based on the rate of Overall Remission (OR=PR+CR +CRi) prior to the initiation of any alternative therapy (including any subsequent ulocuplumab 800 mg for participants in the LDAC alone arm). The phase 2 analysis was conducted after all participants had an opportunity for 6 months of follow-up. Overall remission rate: CR + CRi, + PR confidence interval based on the Clopper and Pearson method. CR = complete response CRi = complete response, incomplete blood count PR = partial remission |
Time Frame | From first dose until a minimum follow-up of up to 2 months |
Outcome Measure Data
Analysis Population Description |
---|
All randomized participants |
Arm/Group Title | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 |
---|---|---|
Arm/Group Description | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) |
Measure Participants | 26 | 14 |
Number (95% Confidence Interval) [Percentage of participants] |
19.2
640%
|
7.1
236.7%
|
Title | Duration of Response in Participants With CR/CRi Treated With Ulocuplumab at Two Different Dose Levels 800 mg and 1000 mg in Combination With LDAC - Phase 2 |
---|---|
Description | This phase 2 secondary endpoint was based on the duration of complete remission prior to the initiation of any alternative therapy (including any subsequent ulocuplumab 800 mg for participants in the LDAC alone arm). The phase 2 analysis was conducted after all participants had an opportunity for 6 months of follow-up. |
Time Frame | From first dose until a minimum follow-up of up to 2 months |
Outcome Measure Data
Analysis Population Description |
---|
All randomized participants with CR/CRi |
Arm/Group Title | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 |
---|---|---|
Arm/Group Description | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) |
Measure Participants | 4 | 1 |
Median (Full Range) [Months] |
2.4
|
4.3
|
Title | Rate of Complete Remission (CR/CRi) and Overall Rate of Remission in Participants Treated With LDAC Only - Phase 2 |
---|---|
Description | This phase 2 secondary endpoint was based on the rate of Complete Remission (CR/CRi) and rate of Overall Remission (OR=PR+CR +CRi) prior to the initiation of any alternative therapy (including any subsequent ulocuplumab 800 mg for participants in the LDAC alone arm). The phase 2 analysis was conducted after all participants had an opportunity for 6 months of follow-up. Overall remission rate: CR + CRi, + PR confidence interval based on the Clopper and Pearson method. CR = complete response CRi = complete response, incomplete blood count PR = partial remission |
Time Frame | From first dose until a minimum follow-up of up to 2 months |
Outcome Measure Data
Analysis Population Description |
---|
All randomized participants |
Arm/Group Title | LDAC - Ph2 |
---|---|
Arm/Group Description | Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission |
Measure Participants | 24 |
CR/CRi |
25.0
833.3%
|
Overall remission rate |
25.0
833.3%
|
Title | Duration of Response in Participants With CR/CRi Treated With LDAC Only - Phase 2 |
---|---|
Description | This phase 2 secondary endpoint was based on the duration of complete remission prior to the initiation of any alternative therapy (including any subsequent ulocuplumab 800 mg for participants in the LDAC alone arm). The phase 2 analysis was conducted after all participants had an opportunity for 6 months of follow-up. |
Time Frame | From first dose until a minimum follow-up of up to 2 months |
Outcome Measure Data
Analysis Population Description |
---|
All randomized participants with CR/CRi |
Arm/Group Title | LDAC - Ph2 |
---|---|
Arm/Group Description | Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission |
Measure Participants | 6 |
Median (Full Range) [Months] |
5.7
|
Title | Change From Baseline of Electrocardiogram (ECG) Endpoints: Heart Rate - Phases 1 and 2 |
---|---|
Description | Change from baseline of ECG endpoints Heart rate measured in beats per minute (bpm) |
Time Frame | From first dose until a minimum follow-up of up to 2 months |
Outcome Measure Data
Analysis Population Description |
---|
All treated participants |
Arm/Group Title | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 | LDAC - Ph2 |
---|---|---|---|---|---|
Arm/Group Description | Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission |
Measure Participants | 3 | 3 | 15 | 13 | 9 |
Cycle 2 Day 1 |
26.0
(63.6)
|
4.0
(18.4)
|
1.8
(11.3)
|
-0.9
(20.0)
|
-3.0
(7.6)
|
Cycle 3, Day 1 |
-2.3
(18.8)
|
0.0
(15.6)
|
5.8
(14.2)
|
12.7
(14.3)
|
1.7
(10.2)
|
Cycle 4, Day 1 |
-1.0
|
-16.0
(5.7)
|
-0.1
(9.9)
|
11.0
(40.6)
|
1.3
(16.7)
|
Cycle 5, Day 1 |
-6.0
|
1.5
(7.8)
|
4.3
(12.3)
|
10.5
(2.1)
|
8.8
(27.5)
|
Cycle 6, Day 1 |
-6.0
|
-6.0
(16.5)
|
6.8
(5.3)
|
7.4
(14.9)
|
|
Cycle 7, Day 1 |
-11.7
(18.6)
|
-3.5
(5.9)
|
12.0
(NA)
|
6.5
(13.5)
|
|
Cycle 8, Day 1 |
-1.0
|
0.7
(2.1)
|
11.0
(NA)
|
0.8
(11.4)
|
|
Cycle 9, Day 1 |
-17.0
(11.3)
|
7.0
(7.1)
|
3.0
(NA)
|
0.6
(8.9)
|
|
Cycle 10, Day 1 |
-3.0
|
-16.0
(NA)
|
9.3
(5.1)
|
2.0
(1.4)
|
|
Cycle 11, Day 1 |
-12.0
|
10.0
(NA)
|
-0.3
(6.7)
|
||
Cycle 12, Day 1 |
5.0
(NA)
|
19.0
(NA)
|
7.0
(2.8)
|
||
Cycle 13, Day 1 |
-9.0
|
8.0
(NA)
|
4.0
(2.8)
|
||
Cycle 14, Day 1 |
14.0
(NA)
|
||||
Cycle 15, Day 1 |
-10.0
|
8.0
(NA)
|
|||
Cycle 16, Day 1 |
18.0
(NA)
|
Title | Change From Baseline of Electrocardiogram (ECG) Endpoints: PR Interval - Phases 1 and 2 |
---|---|
Description | Change from baseline of ECG endpoints PR interval measured in milliseconds (msec) |
Time Frame | From first dose until a minimum follow-up of up to 2 months |
Outcome Measure Data
Analysis Population Description |
---|
All treated participants |
Arm/Group Title | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 | LDAC - Ph2 |
---|---|---|---|---|---|
Arm/Group Description | Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission |
Measure Participants | 3 | 3 | 15 | 10 | 9 |
Cycle 2 Day 1 |
4.0
(NA)
|
-14.0
(19.8)
|
1.1
(23.9)
|
-5.1
(9.9)
|
1.2
(5.3)
|
Cycle 3, Day 1 |
8.0
(6.0)
|
-12.0
(0.0)
|
-5.3
(26.2)
|
-2.8
(8.4)
|
-1.9
(7.5)
|
Cycle 4, Day 1 |
14.0
(NA)
|
-13.0
(1.4)
|
-16.3
(28.4)
|
-10.0
(NA)
|
-11.9
(15.7)
|
Cycle 5, Day 1 |
-2.0
(NA)
|
-16.0
(2.8)
|
-7.6
(24.5)
|
-11.0
(7.1)
|
-24.6
(7.2)
|
Cycle 6, Day 1 |
-44.0
(NA)
|
-19.3
(9.2)
|
-12.8
(21.8)
|
-3.4
(19.5)
|
|
Cycle 7, Day 1 |
-17.3
(9.5)
|
-6.8
(12.0)
|
-2.0
(NA)
|
-8.3
(20.9)
|
|
Cycle 8, Day 1 |
4.0
(NA)
|
-5.3
(27.2)
|
-6.0
(NA)
|
-9.4
(16.2)
|
|
Cycle 9, Day 1 |
-10.0
(0.0)
|
-17.0
(46.7)
|
6.0
(NA)
|
0.6
(8.5)
|
|
Cycle 10, Day 1 |
-4.0
(NA)
|
-2.0
(NA)
|
-11.3
(30.1)
|
1.0
(1.4)
|
|
Cycle 11, Day 1 |
4.0
(NA)
|
4.0
(NA)
|
-1.7
(12.7)
|
||
Cycle 12, Day 1 |
-60.0
(NA)
|
-4.0
(NA)
|
-5.0
(1.4)
|
||
Cycle 13, Day 1 |
-2.0
(NA)
|
-44.0
(NA)
|
3.0
(1.4)
|
||
Cycle 14, Day 1 |
-54.0
(NA)
|
||||
Cycle 15, Day 1 |
0.0
(NA)
|
-10.0
(NA)
|
|||
Cycle 16, Day 1 |
-2.0
(NA)
|
Title | Change From Baseline of Electrocardiogram (ECG) Endpoints: QRS Interval - Phases 1 and 2 |
---|---|
Description | Change from baseline of ECG endpoints QRS interval measured in milliseconds (msec) |
Time Frame | From first dose until a minimum follow-up of up to 2 months |
Outcome Measure Data
Analysis Population Description |
---|
All treated participants |
Arm/Group Title | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 | LDAC - Ph2 |
---|---|---|---|---|---|
Arm/Group Description | Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission |
Measure Participants | 3 | 3 | 15 | 13 | 9 |
Cycle 2 Day 1 |
0.0
(5.7)
|
-2.0
(5.7)
|
5.1
(11.3)
|
0.5
(9.6)
|
4.8
(12.5)
|
Cycle 3, Day 1 |
3.3
(7.6)
|
-2.0
(5.7)
|
-1.3
(7.6)
|
2.0
(3.4)
|
1.4
(8.2)
|
Cycle 4, Day 1 |
0.0
(NA)
|
1.0
(1.4)
|
2.7
(8.8)
|
-3.3
(6.1)
|
6.4
(16.1)
|
Cycle 5, Day 1 |
8.0
(NA)
|
-4.0
(2.8)
|
1.8
(9.5)
|
2.0
(5.7)
|
-1.4
(2.4)
|
Cycle 6, Day 1 |
6.0
(NA)
|
-2.7
(4.2)
|
-1.8
(6.2)
|
5.4
(14.7)
|
|
Cycle 7, Day 1 |
-2.7
(4.2)
|
-3.3
(7.0)
|
-10.0
(NA)
|
-1.5
(4.9)
|
|
Cycle 8, Day 1 |
2.0
(NA)
|
0.7
(2.3)
|
-8.0
(NA)
|
2.6
(6.9)
|
|
Cycle 9, Day 1 |
-1.0
(1.4)
|
-2.0
(8.5)
|
-6.0
(NA)
|
0.0
(3.2)
|
|
Cycle 10, Day 1 |
2.0
(NA)
|
-4.0
(NA)
|
-2.3
(8.6)
|
9.5
(4.9)
|
|
Cycle 11, Day 1 |
6.0
(NA)
|
-4.0
(NA)
|
9.0
(7.5)
|
||
Cycle 12, Day 1 |
-6.0
(NA)
|
-8.0
(NA)
|
10.0
(5.7)
|
||
Cycle 13, Day 1 |
2.0
(NA)
|
-12.0
(NA)
|
3.5
(10.6)
|
||
Cycle 14, Day 1 |
-10.0
(NA)
|
||||
Cycle 15, Day 1 |
6.0
(NA)
|
8.0
(NA)
|
|||
Cycle 16, Day 1 |
7.0
(NA)
|
Title | Change From Baseline of Electrocardiogram (ECG) Endpoints: QT Interval - Phases 1 and 2 |
---|---|
Description | Change from baseline of ECG endpoints QT interval measured in milliseconds (msec) |
Time Frame | From first dose until a minimum follow-up of up to 2 months |
Outcome Measure Data
Analysis Population Description |
---|
All treated participants |
Arm/Group Title | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 | LDAC - Ph2 |
---|---|---|---|---|---|
Arm/Group Description | Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission |
Measure Participants | 3 | 3 | 15 | 13 | 9 |
Cycle 2 Day 1 |
-41.0
(94.8)
|
-5.0
(7.1)
|
4.5
(25.5)
|
10.4
(50.1)
|
14.2
(33.7)
|
Cycle 3, Day 1 |
10.0
(36.7)
|
7.0
(29.7)
|
-15.4
(30.6)
|
-10.7
(41.3)
|
13.7
(41.7)
|
Cycle 4, Day 1 |
-60.0
(NA)
|
35.0
(32.5)
|
10.1
(22.8)
|
-12.7
(104.3)
|
-1.4
(47.9)
|
Cycle 5, Day 1 |
12.0
(NA)
|
13.0
(15.6)
|
2.2
(32.1)
|
-5.0
(26.9)
|
-27.6
(75.5)
|
Cycle 6, Day 1 |
2.0
(NA)
|
6.0
(26.9)
|
-11.8
(19.1)
|
-3.6
(39.3)
|
|
Cycle 7, Day 1 |
29.3
(20.0)
|
11.8
(13.6)
|
-8.0
(NA)
|
-8.8
(28.3)
|
|
Cycle 8, Day 1 |
2.0
(NA)
|
2.0
(2.0)
|
-24.0
(NA)
|
0.8
(35.5)
|
|
Cycle 9, Day 1 |
37.0
(9.9)
|
-23.0
(21.2)
|
-14.0
(NA)
|
-24.4
(23.0)
|
|
Cycle 10, Day 1 |
6.0
(NA)
|
14.0
(NA)
|
-18.3
(18.6)
|
-6.0
(11.3)
|
|
Cycle 11, Day 1 |
16.0
(NA)
|
-22.0
(NA)
|
7.0
(2.6)
|
||
Cycle 12, Day 1 |
-4.0
(NA)
|
-36.0
(NA)
|
-6.5
(27.6)
|
||
Cycle 13, Day 1 |
20.0
(NA)
|
-40.0
(NA)
|
-15.0
(18.4)
|
||
Cycle 14, Day 1 |
-44.0
(NA)
|
||||
Cycle 15, Day 1 |
36.0
(NA)
|
-19.0
(NA)
|
|||
Cycle 16, Day 1 |
-105.0
(NA)
|
Title | Overall Survival (OS) - Phases 1 and 2 |
---|---|
Description | OS is defined as the time between the first date of treatment and the date of death due to any cause. A participant who has not died was be censored at the last known alive date. |
Time Frame | From first dose until a minimum follow-up of up to 2 months |
Outcome Measure Data
Analysis Population Description |
---|
All treated participants for phase 2. Phase 1 OS data not collected. |
Arm/Group Title | ULO 600mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph1 | ULO 800mg + LDAC - Ph2 | ULO 1000mg + LDAC - Ph2 | LDAC - Ph2 |
---|---|---|---|---|---|
Arm/Group Description | Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission |
Measure Participants | 0 | 0 | 26 | 14 | 22 |
Median (Full Range) [Months] |
3.3
|
3.0
|
6.9
|
Adverse Events
Time Frame | Includes on-treatment events from first dose to within 100 days of last dose | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | At the end of the randomized treatment period, 6 participants in the LDAC only arm proceeded to treatment with added ulocuplumab. All 6 of the participants who added ulocuplumab following completion of LDAC only treatment have discontinued treatment. The safety data for these 6 participants are represented in the LDAC arm below. | |||||||||
Arm/Group Title | Ulo 600mg+LDAC | Ulo 800mg+LDAC | Ulocuplumab 800mg + LDAC 20mg BID | Ulocuplumab 1000mg + LDAC 20mg BID | LDAC 20mg BID | |||||
Arm/Group Description | Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1) | Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2) | Low dose cytarabine (LDAC) - Phase 2 (Ph2) Participants in the LDAC only arm were permitted to add ulocuplumab 800 mg into their treatment regimen if they did not achieve complete remission (CR or complete remission with incomplete blood count recovery [CRi]) confirmed by blast count reduction after 4 treatment cycles or if they relapsed after achieving complete remission. | |||||
All Cause Mortality |
||||||||||
Ulo 600mg+LDAC | Ulo 800mg+LDAC | Ulocuplumab 800mg + LDAC 20mg BID | Ulocuplumab 1000mg + LDAC 20mg BID | LDAC 20mg BID | ||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/3 (0%) | 0/3 (0%) | 19/26 (73.1%) | 10/14 (71.4%) | 16/22 (72.7%) | |||||
Serious Adverse Events |
||||||||||
Ulo 600mg+LDAC | Ulo 800mg+LDAC | Ulocuplumab 800mg + LDAC 20mg BID | Ulocuplumab 1000mg + LDAC 20mg BID | LDAC 20mg BID | ||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 2/3 (66.7%) | 1/3 (33.3%) | 21/26 (80.8%) | 8/14 (57.1%) | 15/22 (68.2%) | |||||
Blood and lymphatic system disorders | ||||||||||
Anaemia | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 0/14 (0%) | 1/22 (4.5%) | |||||
Disseminated intravascular coagulation | 1/3 (33.3%) | 0/3 (0%) | 0/26 (0%) | 0/14 (0%) | 0/22 (0%) | |||||
Febrile neutropenia | 2/3 (66.7%) | 0/3 (0%) | 8/26 (30.8%) | 5/14 (35.7%) | 6/22 (27.3%) | |||||
Cardiac disorders | ||||||||||
Arrhythmia | 0/3 (0%) | 0/3 (0%) | 1/26 (3.8%) | 0/14 (0%) | 0/22 (0%) | |||||
Cardiac disorder | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Cardiac failure | 1/3 (33.3%) | 0/3 (0%) | 0/26 (0%) | 0/14 (0%) | 0/22 (0%) | |||||
Eye disorders | ||||||||||
Cataract | 1/3 (33.3%) | 0/3 (0%) | 0/26 (0%) | 0/14 (0%) | 0/22 (0%) | |||||
Gastrointestinal disorders | ||||||||||
Colitis | 0/3 (0%) | 0/3 (0%) | 1/26 (3.8%) | 0/14 (0%) | 0/22 (0%) | |||||
Diarrhoea | 0/3 (0%) | 0/3 (0%) | 2/26 (7.7%) | 0/14 (0%) | 2/22 (9.1%) | |||||
Gastrointestinal haemorrhage | 0/3 (0%) | 0/3 (0%) | 2/26 (7.7%) | 0/14 (0%) | 0/22 (0%) | |||||
Intestinal obstruction | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 0/14 (0%) | 1/22 (4.5%) | |||||
Nausea | 0/3 (0%) | 0/3 (0%) | 1/26 (3.8%) | 0/14 (0%) | 0/22 (0%) | |||||
Oesophagitis | 0/3 (0%) | 0/3 (0%) | 1/26 (3.8%) | 0/14 (0%) | 0/22 (0%) | |||||
Vomiting | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 0/14 (0%) | 1/22 (4.5%) | |||||
General disorders | ||||||||||
Catheter site haemorrhage | 0/3 (0%) | 0/3 (0%) | 1/26 (3.8%) | 0/14 (0%) | 0/22 (0%) | |||||
Complication associated with device | 0/3 (0%) | 0/3 (0%) | 1/26 (3.8%) | 0/14 (0%) | 0/22 (0%) | |||||
Death | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Fatigue | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 0/14 (0%) | 1/22 (4.5%) | |||||
Pyrexia | 0/3 (0%) | 0/3 (0%) | 1/26 (3.8%) | 0/14 (0%) | 0/22 (0%) | |||||
Infections and infestations | ||||||||||
Bacterial infection | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 0/14 (0%) | 1/22 (4.5%) | |||||
Clostridium difficile colitis | 0/3 (0%) | 0/3 (0%) | 1/26 (3.8%) | 0/14 (0%) | 0/22 (0%) | |||||
Lung infection | 0/3 (0%) | 0/3 (0%) | 2/26 (7.7%) | 0/14 (0%) | 0/22 (0%) | |||||
Oesophageal candidiasis | 0/3 (0%) | 0/3 (0%) | 1/26 (3.8%) | 0/14 (0%) | 0/22 (0%) | |||||
Pneumonia | 0/3 (0%) | 0/3 (0%) | 3/26 (11.5%) | 0/14 (0%) | 1/22 (4.5%) | |||||
Pneumonia fungal | 0/3 (0%) | 0/3 (0%) | 1/26 (3.8%) | 0/14 (0%) | 0/22 (0%) | |||||
Sepsis | 0/3 (0%) | 0/3 (0%) | 3/26 (11.5%) | 2/14 (14.3%) | 1/22 (4.5%) | |||||
Septic shock | 0/3 (0%) | 0/3 (0%) | 1/26 (3.8%) | 0/14 (0%) | 1/22 (4.5%) | |||||
Sinusitis | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Skin infection | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 0/14 (0%) | 1/22 (4.5%) | |||||
Injury, poisoning and procedural complications | ||||||||||
Wound dehiscence | 0/3 (0%) | 0/3 (0%) | 1/26 (3.8%) | 0/14 (0%) | 0/22 (0%) | |||||
Investigations | ||||||||||
Amylase increased | 1/3 (33.3%) | 0/3 (0%) | 0/26 (0%) | 0/14 (0%) | 0/22 (0%) | |||||
Metabolism and nutrition disorders | ||||||||||
Dehydration | 0/3 (0%) | 0/3 (0%) | 1/26 (3.8%) | 0/14 (0%) | 1/22 (4.5%) | |||||
Hypokalaemia | 0/3 (0%) | 0/3 (0%) | 1/26 (3.8%) | 0/14 (0%) | 0/22 (0%) | |||||
Lactic acidosis | 0/3 (0%) | 0/3 (0%) | 1/26 (3.8%) | 0/14 (0%) | 0/22 (0%) | |||||
Tumour lysis syndrome | 0/3 (0%) | 0/3 (0%) | 1/26 (3.8%) | 1/14 (7.1%) | 1/22 (4.5%) | |||||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
Acute myeloid leukaemia | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Epstein-Barr virus associated lymphoproliferative disorder | 0/3 (0%) | 1/3 (33.3%) | 0/26 (0%) | 0/14 (0%) | 0/22 (0%) | |||||
Malignant neoplasm progression | 0/3 (0%) | 0/3 (0%) | 5/26 (19.2%) | 2/14 (14.3%) | 6/22 (27.3%) | |||||
Nervous system disorders | ||||||||||
Cerebrovascular accident | 0/3 (0%) | 0/3 (0%) | 1/26 (3.8%) | 0/14 (0%) | 0/22 (0%) | |||||
Dizziness | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 0/14 (0%) | 1/22 (4.5%) | |||||
Seizure | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 0/14 (0%) | 1/22 (4.5%) | |||||
Syncope | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 0/14 (0%) | 1/22 (4.5%) | |||||
Psychiatric disorders | ||||||||||
Confusional state | 0/3 (0%) | 0/3 (0%) | 1/26 (3.8%) | 0/14 (0%) | 0/22 (0%) | |||||
Respiratory, thoracic and mediastinal disorders | ||||||||||
Dyspnoea | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 0/14 (0%) | 1/22 (4.5%) | |||||
Epistaxis | 0/3 (0%) | 0/3 (0%) | 1/26 (3.8%) | 0/14 (0%) | 0/22 (0%) | |||||
Pulmonary embolism | 0/3 (0%) | 0/3 (0%) | 1/26 (3.8%) | 0/14 (0%) | 0/22 (0%) | |||||
Pulmonary haemorrhage | 0/3 (0%) | 0/3 (0%) | 1/26 (3.8%) | 0/14 (0%) | 0/22 (0%) | |||||
Pulmonary oedema | 0/3 (0%) | 0/3 (0%) | 1/26 (3.8%) | 1/14 (7.1%) | 1/22 (4.5%) | |||||
Respiratory failure | 0/3 (0%) | 0/3 (0%) | 2/26 (7.7%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Vascular disorders | ||||||||||
Circulatory collapse | 0/3 (0%) | 0/3 (0%) | 1/26 (3.8%) | 0/14 (0%) | 0/22 (0%) | |||||
Deep vein thrombosis | 0/3 (0%) | 0/3 (0%) | 1/26 (3.8%) | 0/14 (0%) | 0/22 (0%) | |||||
Hypotension | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 0/14 (0%) | 1/22 (4.5%) | |||||
Neurogenic shock | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 0/14 (0%) | 1/22 (4.5%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
Ulo 600mg+LDAC | Ulo 800mg+LDAC | Ulocuplumab 800mg + LDAC 20mg BID | Ulocuplumab 1000mg + LDAC 20mg BID | LDAC 20mg BID | ||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 3/3 (100%) | 3/3 (100%) | 25/26 (96.2%) | 14/14 (100%) | 22/22 (100%) | |||||
Blood and lymphatic system disorders | ||||||||||
Anaemia | 2/3 (66.7%) | 3/3 (100%) | 11/26 (42.3%) | 3/14 (21.4%) | 8/22 (36.4%) | |||||
Febrile neutropenia | 1/3 (33.3%) | 3/3 (100%) | 5/26 (19.2%) | 4/14 (28.6%) | 7/22 (31.8%) | |||||
Increased tendency to bruise | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Leukocytosis | 0/3 (0%) | 0/3 (0%) | 1/26 (3.8%) | 1/14 (7.1%) | 1/22 (4.5%) | |||||
Neutropenia | 0/3 (0%) | 0/3 (0%) | 4/26 (15.4%) | 0/14 (0%) | 0/22 (0%) | |||||
Thrombocytopenia | 0/3 (0%) | 0/3 (0%) | 6/26 (23.1%) | 0/14 (0%) | 2/22 (9.1%) | |||||
Cardiac disorders | ||||||||||
Atrial fibrillation | 1/3 (33.3%) | 0/3 (0%) | 2/26 (7.7%) | 0/14 (0%) | 0/22 (0%) | |||||
Cardiac failure | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 0/14 (0%) | 3/22 (13.6%) | |||||
Tachycardia | 0/3 (0%) | 0/3 (0%) | 2/26 (7.7%) | 0/14 (0%) | 0/22 (0%) | |||||
Ear and labyrinth disorders | ||||||||||
Ear congestion | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Ear discomfort | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Eye disorders | ||||||||||
Dry eye | 1/3 (33.3%) | 0/3 (0%) | 0/26 (0%) | 0/14 (0%) | 0/22 (0%) | |||||
Gastrointestinal disorders | ||||||||||
Abdominal distension | 0/3 (0%) | 0/3 (0%) | 1/26 (3.8%) | 1/14 (7.1%) | 2/22 (9.1%) | |||||
Abdominal pain | 0/3 (0%) | 0/3 (0%) | 2/26 (7.7%) | 1/14 (7.1%) | 1/22 (4.5%) | |||||
Abdominal pain upper | 0/3 (0%) | 0/3 (0%) | 1/26 (3.8%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Constipation | 1/3 (33.3%) | 1/3 (33.3%) | 10/26 (38.5%) | 2/14 (14.3%) | 5/22 (22.7%) | |||||
Diarrhoea | 0/3 (0%) | 0/3 (0%) | 6/26 (23.1%) | 3/14 (21.4%) | 5/22 (22.7%) | |||||
Dyspepsia | 0/3 (0%) | 0/3 (0%) | 2/26 (7.7%) | 0/14 (0%) | 1/22 (4.5%) | |||||
Dysphagia | 0/3 (0%) | 0/3 (0%) | 2/26 (7.7%) | 0/14 (0%) | 0/22 (0%) | |||||
Enteritis | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Flatulence | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Gastritis | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 1/22 (4.5%) | |||||
Glossodynia | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Haemorrhoids | 1/3 (33.3%) | 0/3 (0%) | 1/26 (3.8%) | 1/14 (7.1%) | 2/22 (9.1%) | |||||
Ileus | 0/3 (0%) | 1/3 (33.3%) | 0/26 (0%) | 0/14 (0%) | 0/22 (0%) | |||||
Mouth ulceration | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 2/14 (14.3%) | 1/22 (4.5%) | |||||
Nausea | 1/3 (33.3%) | 2/3 (66.7%) | 6/26 (23.1%) | 8/14 (57.1%) | 6/22 (27.3%) | |||||
Pancreatitis | 0/3 (0%) | 0/3 (0%) | 1/26 (3.8%) | 1/14 (7.1%) | 1/22 (4.5%) | |||||
Periodontal disease | 1/3 (33.3%) | 1/3 (33.3%) | 1/26 (3.8%) | 0/14 (0%) | 0/22 (0%) | |||||
Stomatitis | 1/3 (33.3%) | 3/3 (100%) | 5/26 (19.2%) | 3/14 (21.4%) | 4/22 (18.2%) | |||||
Vomiting | 1/3 (33.3%) | 1/3 (33.3%) | 4/26 (15.4%) | 1/14 (7.1%) | 3/22 (13.6%) | |||||
General disorders | ||||||||||
Asthenia | 0/3 (0%) | 0/3 (0%) | 3/26 (11.5%) | 0/14 (0%) | 2/22 (9.1%) | |||||
Catheter site erythema | 0/3 (0%) | 0/3 (0%) | 2/26 (7.7%) | 0/14 (0%) | 0/22 (0%) | |||||
Chills | 0/3 (0%) | 0/3 (0%) | 1/26 (3.8%) | 3/14 (21.4%) | 2/22 (9.1%) | |||||
Early satiety | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Fatigue | 0/3 (0%) | 0/3 (0%) | 5/26 (19.2%) | 4/14 (28.6%) | 5/22 (22.7%) | |||||
Generalised oedema | 0/3 (0%) | 0/3 (0%) | 1/26 (3.8%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Malaise | 0/3 (0%) | 0/3 (0%) | 3/26 (11.5%) | 0/14 (0%) | 1/22 (4.5%) | |||||
Mass | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Mucosal inflammation | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 1/22 (4.5%) | |||||
Non-cardiac chest pain | 0/3 (0%) | 0/3 (0%) | 2/26 (7.7%) | 2/14 (14.3%) | 0/22 (0%) | |||||
Oedema peripheral | 1/3 (33.3%) | 2/3 (66.7%) | 6/26 (23.1%) | 1/14 (7.1%) | 4/22 (18.2%) | |||||
Pyrexia | 2/3 (66.7%) | 2/3 (66.7%) | 8/26 (30.8%) | 5/14 (35.7%) | 5/22 (22.7%) | |||||
Hepatobiliary disorders | ||||||||||
Drug-induced liver injury | 1/3 (33.3%) | 0/3 (0%) | 0/26 (0%) | 0/14 (0%) | 0/22 (0%) | |||||
Hepatic congestion | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Hepatic function abnormal | 0/3 (0%) | 0/3 (0%) | 2/26 (7.7%) | 0/14 (0%) | 1/22 (4.5%) | |||||
Hepatosplenomegaly | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Hyperbilirubinaemia | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 1/22 (4.5%) | |||||
Immune system disorders | ||||||||||
Hypersensitivity | 1/3 (33.3%) | 1/3 (33.3%) | 1/26 (3.8%) | 2/14 (14.3%) | 0/22 (0%) | |||||
Infections and infestations | ||||||||||
Device related infection | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 0/14 (0%) | 2/22 (9.1%) | |||||
Gingivitis | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 2/14 (14.3%) | 0/22 (0%) | |||||
Herpes simplex | 1/3 (33.3%) | 0/3 (0%) | 0/26 (0%) | 0/14 (0%) | 0/22 (0%) | |||||
Herpes zoster | 1/3 (33.3%) | 0/3 (0%) | 0/26 (0%) | 0/14 (0%) | 0/22 (0%) | |||||
Lung infection | 0/3 (0%) | 0/3 (0%) | 1/26 (3.8%) | 1/14 (7.1%) | 3/22 (13.6%) | |||||
Oral candidiasis | 0/3 (0%) | 0/3 (0%) | 1/26 (3.8%) | 1/14 (7.1%) | 2/22 (9.1%) | |||||
Otitis media | 1/3 (33.3%) | 0/3 (0%) | 0/26 (0%) | 0/14 (0%) | 0/22 (0%) | |||||
Pneumonia | 0/3 (0%) | 0/3 (0%) | 1/26 (3.8%) | 1/14 (7.1%) | 1/22 (4.5%) | |||||
Sepsis | 0/3 (0%) | 0/3 (0%) | 1/26 (3.8%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Skin infection | 1/3 (33.3%) | 0/3 (0%) | 0/26 (0%) | 0/14 (0%) | 1/22 (4.5%) | |||||
Subcutaneous abscess | 1/3 (33.3%) | 0/3 (0%) | 0/26 (0%) | 0/14 (0%) | 0/22 (0%) | |||||
Upper respiratory tract infection | 1/3 (33.3%) | 0/3 (0%) | 0/26 (0%) | 0/14 (0%) | 1/22 (4.5%) | |||||
Urinary tract infection | 0/3 (0%) | 0/3 (0%) | 1/26 (3.8%) | 1/14 (7.1%) | 2/22 (9.1%) | |||||
Injury, poisoning and procedural complications | ||||||||||
Allergic transfusion reaction | 1/3 (33.3%) | 1/3 (33.3%) | 0/26 (0%) | 0/14 (0%) | 0/22 (0%) | |||||
Compression fracture | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Fall | 0/3 (0%) | 0/3 (0%) | 1/26 (3.8%) | 0/14 (0%) | 2/22 (9.1%) | |||||
Infusion related reaction | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 2/14 (14.3%) | 2/22 (9.1%) | |||||
Procedural pain | 0/3 (0%) | 0/3 (0%) | 1/26 (3.8%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Transfusion reaction | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Investigations | ||||||||||
Alanine aminotransferase increased | 1/3 (33.3%) | 0/3 (0%) | 2/26 (7.7%) | 1/14 (7.1%) | 2/22 (9.1%) | |||||
Amylase increased | 0/3 (0%) | 0/3 (0%) | 2/26 (7.7%) | 0/14 (0%) | 0/22 (0%) | |||||
Aspartate aminotransferase increased | 1/3 (33.3%) | 0/3 (0%) | 1/26 (3.8%) | 0/14 (0%) | 0/22 (0%) | |||||
Blood alkaline phosphatase increased | 0/3 (0%) | 1/3 (33.3%) | 1/26 (3.8%) | 1/14 (7.1%) | 1/22 (4.5%) | |||||
Blood bilirubin increased | 0/3 (0%) | 1/3 (33.3%) | 3/26 (11.5%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Blood creatine phosphokinase increased | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Blood creatinine increased | 0/3 (0%) | 0/3 (0%) | 1/26 (3.8%) | 1/14 (7.1%) | 0/22 (0%) | |||||
C-reactive protein increased | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 0/14 (0%) | 2/22 (9.1%) | |||||
Electrocardiogram QT prolonged | 0/3 (0%) | 0/3 (0%) | 1/26 (3.8%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Lipase increased | 1/3 (33.3%) | 0/3 (0%) | 2/26 (7.7%) | 0/14 (0%) | 2/22 (9.1%) | |||||
Neutrophil count decreased | 2/3 (66.7%) | 0/3 (0%) | 3/26 (11.5%) | 1/14 (7.1%) | 6/22 (27.3%) | |||||
Platelet count decreased | 2/3 (66.7%) | 3/3 (100%) | 6/26 (23.1%) | 4/14 (28.6%) | 8/22 (36.4%) | |||||
Troponin T increased | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Weight decreased | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 0/14 (0%) | 2/22 (9.1%) | |||||
White blood cell count decreased | 0/3 (0%) | 0/3 (0%) | 5/26 (19.2%) | 1/14 (7.1%) | 3/22 (13.6%) | |||||
Metabolism and nutrition disorders | ||||||||||
Decreased appetite | 1/3 (33.3%) | 0/3 (0%) | 3/26 (11.5%) | 2/14 (14.3%) | 4/22 (18.2%) | |||||
Dehydration | 1/3 (33.3%) | 0/3 (0%) | 2/26 (7.7%) | 0/14 (0%) | 1/22 (4.5%) | |||||
Diabetes mellitus | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Fluid overload | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Glucose tolerance impaired | 0/3 (0%) | 1/3 (33.3%) | 0/26 (0%) | 0/14 (0%) | 1/22 (4.5%) | |||||
Hyperglycaemia | 1/3 (33.3%) | 0/3 (0%) | 0/26 (0%) | 0/14 (0%) | 2/22 (9.1%) | |||||
Hyperkalaemia | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 2/22 (9.1%) | |||||
Hypermagnesaemia | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Hypernatraemia | 0/3 (0%) | 0/3 (0%) | 2/26 (7.7%) | 0/14 (0%) | 0/22 (0%) | |||||
Hypoalbuminaemia | 0/3 (0%) | 0/3 (0%) | 2/26 (7.7%) | 1/14 (7.1%) | 1/22 (4.5%) | |||||
Hypoglycaemia | 0/3 (0%) | 1/3 (33.3%) | 0/26 (0%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Hypokalaemia | 1/3 (33.3%) | 1/3 (33.3%) | 1/26 (3.8%) | 3/14 (21.4%) | 3/22 (13.6%) | |||||
Hypomagnesaemia | 0/3 (0%) | 0/3 (0%) | 3/26 (11.5%) | 0/14 (0%) | 0/22 (0%) | |||||
Hyponatraemia | 0/3 (0%) | 0/3 (0%) | 2/26 (7.7%) | 2/14 (14.3%) | 1/22 (4.5%) | |||||
Metabolic acidosis | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 1/22 (4.5%) | |||||
Tumour lysis syndrome | 0/3 (0%) | 0/3 (0%) | 2/26 (7.7%) | 0/14 (0%) | 0/22 (0%) | |||||
Musculoskeletal and connective tissue disorders | ||||||||||
Arthralgia | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 2/22 (9.1%) | |||||
Back pain | 2/3 (66.7%) | 0/3 (0%) | 0/26 (0%) | 4/14 (28.6%) | 0/22 (0%) | |||||
Bone pain | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Costochondritis | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Joint swelling | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Muscular weakness | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Musculoskeletal chest pain | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Musculoskeletal pain | 0/3 (0%) | 0/3 (0%) | 1/26 (3.8%) | 1/14 (7.1%) | 1/22 (4.5%) | |||||
Neck pain | 0/3 (0%) | 0/3 (0%) | 1/26 (3.8%) | 2/14 (14.3%) | 1/22 (4.5%) | |||||
Pain in extremity | 1/3 (33.3%) | 0/3 (0%) | 1/26 (3.8%) | 0/14 (0%) | 0/22 (0%) | |||||
Polymyalgia rheumatica | 1/3 (33.3%) | 0/3 (0%) | 0/26 (0%) | 0/14 (0%) | 0/22 (0%) | |||||
Tendonitis | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
Acute myeloid leukaemia | 0/3 (0%) | 0/3 (0%) | 1/26 (3.8%) | 0/14 (0%) | 3/22 (13.6%) | |||||
Nervous system disorders | ||||||||||
Dizziness | 0/3 (0%) | 0/3 (0%) | 2/26 (7.7%) | 0/14 (0%) | 2/22 (9.1%) | |||||
Headache | 0/3 (0%) | 0/3 (0%) | 3/26 (11.5%) | 3/14 (21.4%) | 2/22 (9.1%) | |||||
Psychiatric disorders | ||||||||||
Adjustment disorder with depressed mood | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Anxiety | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 2/14 (14.3%) | 0/22 (0%) | |||||
Confusional state | 0/3 (0%) | 0/3 (0%) | 2/26 (7.7%) | 0/14 (0%) | 0/22 (0%) | |||||
Delirium | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Insomnia | 0/3 (0%) | 0/3 (0%) | 7/26 (26.9%) | 1/14 (7.1%) | 1/22 (4.5%) | |||||
Renal and urinary disorders | ||||||||||
Acute kidney injury | 1/3 (33.3%) | 0/3 (0%) | 1/26 (3.8%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Haematuria | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Renal tubular disorder | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Reproductive system and breast disorders | ||||||||||
Breast pain | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Genital ulceration | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Prostatitis | 0/3 (0%) | 1/3 (33.3%) | 0/26 (0%) | 0/14 (0%) | 0/22 (0%) | |||||
Respiratory, thoracic and mediastinal disorders | ||||||||||
Cough | 0/3 (0%) | 2/3 (66.7%) | 6/26 (23.1%) | 3/14 (21.4%) | 2/22 (9.1%) | |||||
Dyspnoea | 0/3 (0%) | 0/3 (0%) | 5/26 (19.2%) | 4/14 (28.6%) | 1/22 (4.5%) | |||||
Dyspnoea exertional | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Epistaxis | 0/3 (0%) | 0/3 (0%) | 2/26 (7.7%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Hypoxia | 0/3 (0%) | 0/3 (0%) | 1/26 (3.8%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Interstitial lung disease | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Oropharyngeal pain | 0/3 (0%) | 1/3 (33.3%) | 3/26 (11.5%) | 2/14 (14.3%) | 1/22 (4.5%) | |||||
Pleural effusion | 0/3 (0%) | 0/3 (0%) | 1/26 (3.8%) | 1/14 (7.1%) | 1/22 (4.5%) | |||||
Productive cough | 0/3 (0%) | 0/3 (0%) | 3/26 (11.5%) | 0/14 (0%) | 0/22 (0%) | |||||
Rhinorrhoea | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 2/14 (14.3%) | 0/22 (0%) | |||||
Stridor | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Upper respiratory tract inflammation | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Wheezing | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 2/14 (14.3%) | 1/22 (4.5%) | |||||
Skin and subcutaneous tissue disorders | ||||||||||
Acute febrile neutrophilic dermatosis | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 0/14 (0%) | 2/22 (9.1%) | |||||
Dermatitis allergic | 0/3 (0%) | 1/3 (33.3%) | 0/26 (0%) | 0/14 (0%) | 0/22 (0%) | |||||
Drug eruption | 1/3 (33.3%) | 0/3 (0%) | 0/26 (0%) | 0/14 (0%) | 0/22 (0%) | |||||
Dry skin | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 1/22 (4.5%) | |||||
Ecchymosis | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 2/22 (9.1%) | |||||
Erythema | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 2/14 (14.3%) | 1/22 (4.5%) | |||||
Petechiae | 0/3 (0%) | 0/3 (0%) | 2/26 (7.7%) | 2/14 (14.3%) | 0/22 (0%) | |||||
Pruritus | 0/3 (0%) | 1/3 (33.3%) | 0/26 (0%) | 1/14 (7.1%) | 1/22 (4.5%) | |||||
Rash | 1/3 (33.3%) | 0/3 (0%) | 0/26 (0%) | 3/14 (21.4%) | 2/22 (9.1%) | |||||
Rash maculo-papular | 0/3 (0%) | 0/3 (0%) | 2/26 (7.7%) | 1/14 (7.1%) | 2/22 (9.1%) | |||||
Skin exfoliation | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Vascular disorders | ||||||||||
Haematoma | 0/3 (0%) | 0/3 (0%) | 2/26 (7.7%) | 0/14 (0%) | 1/22 (4.5%) | |||||
Haemorrhage | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Hypertension | 1/3 (33.3%) | 0/3 (0%) | 3/26 (11.5%) | 2/14 (14.3%) | 1/22 (4.5%) | |||||
Hypotension | 0/3 (0%) | 0/3 (0%) | 0/26 (0%) | 1/14 (7.1%) | 0/22 (0%) | |||||
Vasculitis | 0/3 (0%) | 0/3 (0%) | 3/26 (11.5%) | 0/14 (0%) | 0/22 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title | Bristol-Myers Squibb Study Director |
---|---|
Organization | Bristol-Myers Squibb |
Phone | Please email: |
Clinical.Trials@bms.com |
- CA212-016