Trial Outcomes & Findings for An Investigational Immuno-therapy Study of Ulocuplumab in Combination With Low Dose Cytarabine in Patients With Newly Diagnosed Acute Myeloid Leukemia (NCT NCT02305563)
NCT ID: NCT02305563
Last Updated: 2021-09-16
Results Overview
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).
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
70 participants
Primary outcome timeframe
From first dose to end of cycle 1 (28 days)
Results posted on
2021-09-16
Participant Flow
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.
Participant milestones
| Measure |
ULO 600mg + LDAC - Ph1
Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
ULO 800mg + LDAC - Ph1
Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
ULO 800mg + LDAC - Ph2
Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
|
ULO 1000mg + LDAC - Ph2
Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
|
LDAC - 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
|
|---|---|---|---|---|---|
|
Treatment Period
STARTED
|
3
|
3
|
26
|
14
|
24
|
|
Treatment Period
COMPLETED
|
1
|
1
|
0
|
0
|
0
|
|
Treatment Period
NOT COMPLETED
|
2
|
2
|
26
|
14
|
24
|
|
Follow-up Period
STARTED
|
3
|
3
|
11
|
6
|
12
|
|
Follow-up Period
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Follow-up Period
NOT COMPLETED
|
3
|
3
|
11
|
6
|
12
|
Reasons for withdrawal
| Measure |
ULO 600mg + LDAC - Ph1
Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
ULO 800mg + LDAC - Ph1
Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
ULO 800mg + LDAC - Ph2
Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
|
ULO 1000mg + LDAC - Ph2
Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
|
LDAC - 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
|
|---|---|---|---|---|---|
|
Treatment Period
Disease progression
|
0
|
0
|
15
|
6
|
6
|
|
Treatment Period
Study drug toxicity
|
0
|
0
|
0
|
1
|
2
|
|
Treatment Period
Death
|
0
|
0
|
1
|
2
|
1
|
|
Treatment Period
Adverse Event (AE) unrelated to drug
|
0
|
0
|
7
|
1
|
2
|
|
Treatment Period
Participant request to stop therapy
|
0
|
2
|
0
|
1
|
0
|
|
Treatment Period
Participant withdrew consent
|
0
|
0
|
1
|
1
|
1
|
|
Treatment Period
Maximum clinical benefit
|
0
|
0
|
0
|
0
|
1
|
|
Treatment Period
Poor/non-compliance
|
0
|
0
|
0
|
0
|
1
|
|
Treatment Period
Administrative reason by Sponsor
|
0
|
0
|
0
|
0
|
1
|
|
Treatment Period
other reason
|
2
|
0
|
2
|
2
|
1
|
|
Treatment Period
Randomized but not treated
|
0
|
0
|
0
|
0
|
2
|
|
Treatment Period
added ULO, then disease progression
|
0
|
0
|
0
|
0
|
4
|
|
Treatment Period
added ULO; then other reason
|
0
|
0
|
0
|
0
|
1
|
|
Treatment Period
added ULO, then request to stop
|
0
|
0
|
0
|
0
|
1
|
|
Follow-up Period
Death
|
0
|
0
|
5
|
4
|
7
|
|
Follow-up Period
Participant withdrew consent
|
0
|
0
|
2
|
1
|
0
|
|
Follow-up Period
other reason
|
0
|
0
|
0
|
0
|
1
|
|
Follow-up Period
Followup no longer required per protocol
|
3
|
3
|
4
|
1
|
4
|
Baseline Characteristics
data not collected
Baseline characteristics by cohort
| Measure |
ULO 600mg + LDAC - Ph1
n=3 Participants
Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
ULO 800mg + LDAC - Ph1
n=3 Participants
Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
ULO 800mg + LDAC - Ph2
n=26 Participants
Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
|
ULO 1000mg + LDAC - Ph2
n=14 Participants
Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
|
LDAC - Ph2
n=24 Participants
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
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
73.7 Years
STANDARD_DEVIATION 8.02 • n=3 Participants
|
77.3 Years
STANDARD_DEVIATION 1.53 • n=3 Participants
|
74.9 Years
STANDARD_DEVIATION 5.4 • n=26 Participants
|
73.1 Years
STANDARD_DEVIATION 3.7 • n=14 Participants
|
75.9 Years
STANDARD_DEVIATION 5.7 • n=24 Participants
|
74.9 Years
STANDARD_DEVIATION 5.21 • n=70 Participants
|
|
Age, Customized
<70
|
1 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
4 Participants
n=26 Participants
|
3 Participants
n=14 Participants
|
3 Participants
n=24 Participants
|
11 Participants
n=70 Participants
|
|
Age, Customized
>=70
|
2 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
22 Participants
n=26 Participants
|
11 Participants
n=14 Participants
|
21 Participants
n=24 Participants
|
59 Participants
n=70 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
9 Participants
n=26 Participants
|
7 Participants
n=14 Participants
|
14 Participants
n=24 Participants
|
33 Participants
n=70 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
17 Participants
n=26 Participants
|
7 Participants
n=14 Participants
|
10 Participants
n=24 Participants
|
37 Participants
n=70 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
—
|
—
|
—
|
—
|
—
|
0 Participants
data not collected
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
|
—
|
—
|
—
|
—
|
0 Participants
data not collected
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
|
—
|
—
|
—
|
—
|
0 Participants
data not collected
|
|
Race/Ethnicity, Customized
White
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
15 Participants
n=26 Participants
|
4 Participants
n=14 Participants
|
12 Participants
n=24 Participants
|
31 Participants
n=70 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=70 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
6 Participants
n=26 Participants
|
6 Participants
n=14 Participants
|
4 Participants
n=24 Participants
|
22 Participants
n=70 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=26 Participants
|
2 Participants
n=14 Participants
|
3 Participants
n=24 Participants
|
7 Participants
n=70 Participants
|
|
Race/Ethnicity, Customized
Asian Indian
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=70 Participants
|
|
Race/Ethnicity, Customized
Asian Other
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
3 Participants
n=26 Participants
|
0 Participants
n=14 Participants
|
2 Participants
n=24 Participants
|
5 Participants
n=70 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskan Native
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=26 Participants
|
1 Participants
n=14 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=70 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Other Pacific Islander
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=70 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=26 Participants
|
1 Participants
n=14 Participants
|
3 Participants
n=24 Participants
|
4 Participants
n=70 Participants
|
PRIMARY outcome
Timeframe: From first dose to end of cycle 1 (28 days)Population: All treated participants
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).
Outcome measures
| Measure |
ULO 600mg + LDAC - Ph1
n=3 Participants
Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
ULO 800mg + LDAC - Ph1
n=3 Participants
Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
LDAC - 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
|
ULO 1000mg + LDAC - Ph2
Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
|
LDAC - 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
|
|---|---|---|---|---|---|
|
Number of Participants With Dose-Limiting Toxicities (DLTs) in Treatment Cycle 1 - Phase 1
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose to 30 days post last dosePopulation: All treated participants
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).
Outcome measures
| Measure |
ULO 600mg + LDAC - Ph1
n=3 Participants
Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
ULO 800mg + LDAC - Ph1
n=3 Participants
Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
LDAC - 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
|
ULO 1000mg + LDAC - Ph2
Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
|
LDAC - 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
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) - Phase 1
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose to 30 days post last dosePopulation: All treated participants
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).
Outcome measures
| Measure |
ULO 600mg + LDAC - Ph1
n=3 Participants
Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
ULO 800mg + LDAC - Ph1
n=3 Participants
Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
LDAC - 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
|
ULO 1000mg + LDAC - Ph2
Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
|
LDAC - 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
|
|---|---|---|---|---|---|
|
Number of Participants With >= Grade 3 AEs - Phase 1
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose to 30 days post last dosePopulation: All treated participants
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).
Outcome measures
| Measure |
ULO 600mg + LDAC - Ph1
n=3 Participants
Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
ULO 800mg + LDAC - Ph1
n=3 Participants
Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
LDAC - 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
|
ULO 1000mg + LDAC - Ph2
Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
|
LDAC - 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
|
|---|---|---|---|---|---|
|
Number of Participants With AEs Leading to Discontinuation - Phase 1
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose to 30 days post last dosePopulation: All treated participants
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).
Outcome measures
| Measure |
ULO 600mg + LDAC - Ph1
n=3 Participants
Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
ULO 800mg + LDAC - Ph1
n=3 Participants
Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
LDAC - 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
|
ULO 1000mg + LDAC - Ph2
Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
|
LDAC - 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
|
|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) - Phase 1
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose to 30 days post last dosePopulation: All treated participants
The number of participants who died.
Outcome measures
| Measure |
ULO 600mg + LDAC - Ph1
n=3 Participants
Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
ULO 800mg + LDAC - Ph1
n=3 Participants
Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
LDAC - 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
|
ULO 1000mg + LDAC - Ph2
Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
|
LDAC - 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
|
|---|---|---|---|---|---|
|
Number of Deaths - Phase 1
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose to 30 days post last dosePopulation: All treated participants
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
Outcome measures
| Measure |
ULO 600mg + LDAC - Ph1
n=3 Participants
Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
ULO 800mg + LDAC - Ph1
n=3 Participants
Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
LDAC - 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
|
ULO 1000mg + LDAC - Ph2
Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
|
LDAC - 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
|
|---|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities - Phase 1
POTASSIUM, SERUM - grade 3
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
SODIUM, SERUM - grade 0
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
SODIUM, SERUM - grade 1
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
ABSOLUTE NEUTROPHIL COUNT - grade 3
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
ABSOLUTE NEUTROPHIL COUNT - grade 4
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
ALANINE AMINOTRANSFERASE - grade 0
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
ALANINE AMINOTRANSFERASE - grade 1
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
ALBUMIN - grade 0
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
ALBUMIN - grade 1
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
ALBUMIN - grade 2
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
ALKALINE PHOSPHATASE - grade 0
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
ALKALINE PHOSPHATASE grade 1
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
ASPARTATE AMINOTRANSFERASE - grade 0
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
ASPARTATE AMINOTRANSFERASE - grade 1
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
BILIRUBIN, TOTAL - grade 0
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
BILIRUBIN, TOTAL - grade 2
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
CALCIUM, TOTAL - grade 0
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
CALCIUM, TOTAL - grade 1
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
CALCIUM, TOTAL - grade 2
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
CREATINE KINASE - grade 0
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
CREATININE - grade 0
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
CREATININE - grade 1
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
FIBRINOGEN - grade 0
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
GLUCOSE, FASTING SERUM - grade 0
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
GLUCOSE, FASTING SERUM - grade 1
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
GLUCOSE, FASTING SERUM - grade 2
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
HEMOGLOBIN - grade 2
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
HEMOGLOBIN - grade 3
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
LEUKOCYTES - grade 0
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
LEUKOCYTES - grade 3
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
LEUKOCYTES - grade 4
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
LIPASE, TOTAL (COLORIMETRIC ASSAY) - grade 0
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
LIPASE, TOTAL (COLORIMETRIC ASSAY) - grade 1
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
LIPASE, TOTAL (COLORIMETRIC ASSAY) - grade 3
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
LYMPHOCYTES (ABSOLUTE) - grade 0
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
LYMPHOCYTES (ABSOLUTE) - grade 1
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
LYMPHOCYTES (ABSOLUTE) - grade 2
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
LYMPHOCYTES (ABSOLUTE) - grade 3
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
NEUTROPHILS (ABSOLUTE) - grade 3
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
NEUTROPHILS (ABSOLUTE) - grade 4
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
PHOSPHORUS, INORGANIC - grade 0
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
PHOSPHORUS, INORGANIC - grade 3
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
PLATELET COUNT - grade 3
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
PLATELET COUNT - grade 4
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
POTASSIUM, SERUM - grade 0
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
POTASSIUM, SERUM - grade 1
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
SODIUM, SERUM - grade 3
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
URIC ACID - grade 0
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 1
URIC ACID - grade 1
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose until a minimum follow-up of up to 2 monthsPopulation: All randomized participants
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
Outcome measures
| Measure |
ULO 600mg + LDAC - Ph1
n=26 Participants
Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
ULO 800mg + LDAC - Ph1
n=14 Participants
Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
LDAC - Ph2
n=24 Participants
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
|
ULO 1000mg + LDAC - Ph2
Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
|
LDAC - 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
|
|---|---|---|---|---|---|
|
Best Overall Response (BOR) - Phase 2
|
15.4 Percentage of participants
Interval 4.4 to 34.9
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
25.0 Percentage of participants
Interval 9.8 to 46.7
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose until a minimum follow-up of up to 2 monthsPopulation: All randomized participants
Investigator assessed best overall response prior to the initiation of any alternative therapy for Phase 1 participants.
Outcome measures
| Measure |
ULO 600mg + LDAC - Ph1
n=3 Participants
Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
ULO 800mg + LDAC - Ph1
n=3 Participants
Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
LDAC - 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
|
ULO 1000mg + LDAC - Ph2
Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
|
LDAC - 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
|
|---|---|---|---|---|---|
|
Best Overall Response (BOR) - Phase 1
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose until a minimum follow-up of up to 2 monthsPopulation: All treated participants
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).
Outcome measures
| Measure |
ULO 600mg + LDAC - Ph1
n=26 Participants
Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
ULO 800mg + LDAC - Ph1
n=14 Participants
Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
LDAC - Ph2
n=22 Participants
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
|
ULO 1000mg + LDAC - Ph2
Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
|
LDAC - 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
|
|---|---|---|---|---|---|
|
Number of Participants With AEs - Phase 2
|
25 Participants
|
14 Participants
|
22 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose until a minimum follow-up of up to 2 monthsPopulation: All treated participants
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).
Outcome measures
| Measure |
ULO 600mg + LDAC - Ph1
n=26 Participants
Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
ULO 800mg + LDAC - Ph1
n=14 Participants
Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
LDAC - Ph2
n=22 Participants
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
|
ULO 1000mg + LDAC - Ph2
Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
|
LDAC - 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
|
|---|---|---|---|---|---|
|
Number of Participants With AEs Leading to Discontinuation - Phase 2
|
7 Participants
|
3 Participants
|
4 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose until a minimum follow-up of up to 2 monthsPopulation: All treated participants
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).
Outcome measures
| Measure |
ULO 600mg + LDAC - Ph1
n=26 Participants
Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
ULO 800mg + LDAC - Ph1
n=14 Participants
Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
LDAC - Ph2
n=22 Participants
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
|
ULO 1000mg + LDAC - Ph2
Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
|
LDAC - 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
|
|---|---|---|---|---|---|
|
Number of Participants With SAEs - Phase 2
|
21 Participants
|
8 Participants
|
15 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose until a minimum follow-up of up to 2 monthsPopulation: All treated participants
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).
Outcome measures
| Measure |
ULO 600mg + LDAC - Ph1
n=26 Participants
Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
ULO 800mg + LDAC - Ph1
n=14 Participants
Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
LDAC - Ph2
n=22 Participants
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
|
ULO 1000mg + LDAC - Ph2
Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
|
LDAC - 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
|
|---|---|---|---|---|---|
|
Number of Deaths- Phase 2
|
19 Participants
|
10 Participants
|
16 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose until a minimum follow-up of up to 2 monthsPopulation: All treated participants
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).
Outcome measures
| Measure |
ULO 600mg + LDAC - Ph1
n=26 Participants
Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
ULO 800mg + LDAC - Ph1
n=14 Participants
Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
LDAC - Ph2
n=22 Participants
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
|
ULO 1000mg + LDAC - Ph2
Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
|
LDAC - 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
|
|---|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities - Phase 2
ALANINE AMINOTRANSFERASE (ALT), grade 3
|
2 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
ALKALINE PHOSPHATASE (ALP), grade 1
|
9 Participants
|
3 Participants
|
8 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
ALKALINE PHOSPHATASE (ALP), grade 2
|
1 Participants
|
5 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
ASPARTATE AMINOTRANSFERASE (AST), grade 1
|
7 Participants
|
8 Participants
|
4 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
CREATININE, grade 2
|
5 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
CALCIUM, TOTAL, grade 1
|
7 Participants
|
3 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
ALANINE AMINOTRANSFERASE (ALT), grade 1
|
5 Participants
|
5 Participants
|
4 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
ALANINE AMINOTRANSFERASE (ALT), grade 2
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
ASPARTATE AMINOTRANSFERASE (AST), grade 2
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
ASPARTATE AMINOTRANSFERASE (AST), grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
BILIRUBIN, TOTAL, grade 1
|
3 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
BILIRUBIN, TOTAL, grade 2
|
4 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
BILIRUBIN, TOTAL, grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
CREATININE, grade 1
|
7 Participants
|
5 Participants
|
6 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
CALCIUM, TOTAL, grade 2
|
5 Participants
|
5 Participants
|
7 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
CALCIUM, TOTAL, grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
PHOSPHORUS, INORGANIC, grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
PHOSPHORUS, INORGANIC, grade 2
|
3 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
PHOSPHORUS, INORGANIC, grade 3
|
2 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
PHOSPHORUS, INORGANIC, grade 4
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
POTASSIUM, SERUM, grade 1
|
4 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
POTASSIUM, SERUM, grade 2
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
POTASSIUM, SERUM, grade 3
|
1 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
POTASSIUM, SERUM, grade 4
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
SODIUM, SERUM, grade 1
|
9 Participants
|
3 Participants
|
7 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
SODIUM, SERUM, grade 2
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
SODIUM, SERUM, grade 3
|
0 Participants
|
3 Participants
|
4 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
HEMOGLOBIN, grade 2
|
2 Participants
|
4 Participants
|
4 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
HEMOGLOBIN, grade 3
|
22 Participants
|
10 Participants
|
17 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
PLATELET COUNT, grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
PLATELET COUNT, grade 3
|
1 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
PLATELET COUNT, grade 4
|
23 Participants
|
13 Participants
|
17 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
ABSOLUTE NEUTROPHIL COUNT, grade 1
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
ABSOLUTE NEUTROPHIL COUNT, grade 2
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
ABSOLUTE NEUTROPHIL COUNT, grade 3
|
3 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
ABSOLUTE NEUTROPHIL COUNT, grade 4
|
18 Participants
|
10 Participants
|
16 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
LEUKOCYTES, grade 1
|
3 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
LEUKOCYTES, grade 2
|
3 Participants
|
4 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
LEUKOCYTES, grade 3
|
6 Participants
|
4 Participants
|
5 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
LEUKOCYTES, grade 4
|
8 Participants
|
1 Participants
|
10 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
LYMPHOCYTES (ABSOLUTE), grade 1
|
3 Participants
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
LYMPHOCYTES (ABSOLUTE), grade 2
|
7 Participants
|
1 Participants
|
7 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
LYMPHOCYTES (ABSOLUTE), grade 3
|
5 Participants
|
0 Participants
|
7 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
LYMPHOCYTES (ABSOLUTE), grade 4
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
NEUTROPHILS (ABSOLUTE), grade 1
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
NEUTROPHILS (ABSOLUTE), grade 2
|
1 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
NEUTROPHILS (ABSOLUTE), grade 3
|
3 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Phase 2
NEUTROPHILS (ABSOLUTE), grade 4
|
18 Participants
|
10 Participants
|
16 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose until a minimum follow-up of up to 2 monthsPopulation: All participants treated with ulocuplumab
Serum samples from ulocuplumab treated participants were evaluated for the presence of anti-ulocuplumab antibodies
Outcome measures
| Measure |
ULO 600mg + LDAC - Ph1
n=3 Participants
Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
ULO 800mg + LDAC - Ph1
n=3 Participants
Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
LDAC - Ph2
n=21 Participants
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
|
ULO 1000mg + LDAC - Ph2
n=14 Participants
Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
|
LDAC - 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
|
|---|---|---|---|---|---|
|
Number of Participants With Anti-drug Antibodies (ADA) Positive for Ulocuplumab - Phases 1 and 2
|
0 Participants
|
0 Participants
|
6 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1Population: All treated participants who have evaluable PK profiles
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
Outcome measures
| Measure |
ULO 600mg + LDAC - Ph1
n=3 Participants
Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
ULO 800mg + LDAC - Ph1
n=3 Participants
Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
LDAC - Ph2
n=17 Participants
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
|
ULO 1000mg + LDAC - Ph2
n=14 Participants
Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
|
LDAC - Ph2
n=1 Participants
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
|
|---|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) - Phases 1 and 2
|
219.354 µg/mL
Geometric Coefficient of Variation 19
|
265.294 µg/mL
Geometric Coefficient of Variation 8
|
183.456 µg/mL
Geometric Coefficient of Variation 25
|
256.906 µg/mL
Geometric Coefficient of Variation 22
|
212.564 µg/mL
Geometric Coefficient of Variation NA
Not applicable as n=1
|
SECONDARY outcome
Timeframe: 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)Population: All treated participants who have evaluable PK profiles
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
Outcome measures
| Measure |
ULO 600mg + LDAC - Ph1
n=3 Participants
Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
ULO 800mg + LDAC - Ph1
n=3 Participants
Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
LDAC - Ph2
n=22 Participants
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
|
ULO 1000mg + LDAC - Ph2
n=13 Participants
Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
|
LDAC - Ph2
n=1 Participants
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
|
|---|---|---|---|---|---|
|
Trough Observed Serum Concentration (Ctrough) - Phases 1 and 2
Cycle 9 Day 1
|
—
|
—
|
35.144 µg/mL
Geometric Coefficient of Variation 110
|
187.930 µg/mL
Geometric Coefficient of Variation NA
Not applicable as n=1
|
—
|
|
Trough Observed Serum Concentration (Ctrough) - Phases 1 and 2
Cycle 1 Day 8
|
5.308 µg/mL
Geometric Coefficient of Variation 89
|
75.890 µg/mL
Geometric Coefficient of Variation 30
|
10.321 µg/mL
Geometric Coefficient of Variation 85
|
17.766 µg/mL
Geometric Coefficient of Variation 79
|
39.609 µg/mL
Geometric Coefficient of Variation NA
Not applicable as n=1
|
|
Trough Observed Serum Concentration (Ctrough) - Phases 1 and 2
Cycle 1 Day 1
|
0.100 µg/mL
Geometric Coefficient of Variation 0
|
0.100 µg/mL
Geometric Coefficient of Variation 0
|
0.100 µg/mL
Geometric Coefficient of Variation 0
|
0.100 µg/mL
Geometric Coefficient of Variation 0
|
0.100 µg/mL
Geometric Coefficient of Variation NA
Not applicable as n=1
|
|
Trough Observed Serum Concentration (Ctrough) - Phases 1 and 2
Cycle 1 Day 15
|
21.748 µg/mL
Geometric Coefficient of Variation 91
|
125.797 µg/mL
Geometric Coefficient of Variation 18
|
37.263 µg/mL
Geometric Coefficient of Variation 66
|
61.250 µg/mL
Geometric Coefficient of Variation 64
|
175.315 µg/mL
Geometric Coefficient of Variation NA
Not applicable as n=1
|
|
Trough Observed Serum Concentration (Ctrough) - Phases 1 and 2
Cycle 2 Day 8
|
41.630 µg/mL
Geometric Coefficient of Variation NA
Not applicable as n=1
|
96.333 µg/mL
Geometric Coefficient of Variation 36
|
30.916 µg/mL
Geometric Coefficient of Variation 83
|
103.322 µg/mL
Geometric Coefficient of Variation 67
|
—
|
|
Trough Observed Serum Concentration (Ctrough) - Phases 1 and 2
Cycle 2 Day 15
|
72.104 µg/mL
Geometric Coefficient of Variation NA
Not applicable as n=1
|
126.029 µg/mL
Geometric Coefficient of Variation 49
|
48.421 µg/mL
Geometric Coefficient of Variation 73
|
143.724 µg/mL
Geometric Coefficient of Variation 58
|
—
|
|
Trough Observed Serum Concentration (Ctrough) - Phases 1 and 2
Cycle 3 Day 1
|
—
|
78.218 µg/mL
Geometric Coefficient of Variation NA
Not applicable as n=1
|
13.905 µg/mL
Geometric Coefficient of Variation 101
|
153.871 µg/mL
Geometric Coefficient of Variation 70
|
—
|
|
Trough Observed Serum Concentration (Ctrough) - Phases 1 and 2
Cycle 3 Day 8
|
85.993 µg/mL
Geometric Coefficient of Variation NA
Not applicable as n=1
|
129.580 µg/mL
Geometric Coefficient of Variation 42
|
37.602 µg/mL
Geometric Coefficient of Variation 94
|
82.033 µg/mL
Geometric Coefficient of Variation 21
|
—
|
|
Trough Observed Serum Concentration (Ctrough) - Phases 1 and 2
Cycle 4 Day 1
|
—
|
80.409 µg/mL
Geometric Coefficient of Variation 64
|
4.012 µg/mL
Geometric Coefficient of Variation 145
|
212.793 µg/mL
Geometric Coefficient of Variation NA
Not applicable as n=1
|
—
|
|
Trough Observed Serum Concentration (Ctrough) - Phases 1 and 2
Cycle 4 Day 8
|
112.048 µg/mL
Geometric Coefficient of Variation NA
Not applicable as n=1
|
133.650 µg/mL
Geometric Coefficient of Variation 41
|
116.657 µg/mL
Geometric Coefficient of Variation 83
|
77.095 µg/mL
Geometric Coefficient of Variation 119
|
—
|
|
Trough Observed Serum Concentration (Ctrough) - Phases 1 and 2
Cycle 5 Day 1
|
—
|
32.621 µg/mL
Geometric Coefficient of Variation NA
Not applicable as n=1
|
4.558 µg/mL
Geometric Coefficient of Variation 166
|
224.703 µg/mL
Geometric Coefficient of Variation NA
Not applicable as n=1
|
—
|
|
Trough Observed Serum Concentration (Ctrough) - Phases 1 and 2
Cycle 5 Day 8
|
102.751 µg/mL
Geometric Coefficient of Variation NA
Not applicable as n=1
|
124.996 µg/mL
Geometric Coefficient of Variation 48
|
34.783 µg/mL
Geometric Coefficient of Variation 137
|
202.552 µg/mL
Geometric Coefficient of Variation NA
Not applicable as n=1
|
—
|
|
Trough Observed Serum Concentration (Ctrough) - Phases 1 and 2
EOT
|
—
|
—
|
0.100 µg/mL
Geometric Coefficient of Variation NA
Not applicable as n=1
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1Population: All treated participants who have evaluable PK profiles
The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration. EOT = end of treatment
Outcome measures
| Measure |
ULO 600mg + LDAC - Ph1
n=3 Participants
Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
ULO 800mg + LDAC - Ph1
n=3 Participants
Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
LDAC - Ph2
n=17 Participants
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
|
ULO 1000mg + LDAC - Ph2
n=7 Participants
Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
|
LDAC - Ph2
n=1 Participants
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
|
|---|---|---|---|---|---|
|
Time of Maximum Observed Ulocuplumab Serum Concentration (Tmax) - Phases 1 and 2
|
1.850 hour (H)
Interval 1.47 to 2.02
|
1.933 hour (H)
Interval 1.68 to 2.03
|
1.500 hour (H)
Interval 1.0 to 4.5
|
2.117 hour (H)
Interval 1.28 to 5.12
|
2.03 hour (H)
Interval 2.03 to 2.03
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1Population: All treated participants who have evaluable PK profiles
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
Outcome measures
| Measure |
ULO 600mg + LDAC - Ph1
n=3 Participants
Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
ULO 800mg + LDAC - Ph1
n=3 Participants
Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
LDAC - Ph2
n=17 Participants
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
|
ULO 1000mg + LDAC - Ph2
n=7 Participants
Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
|
LDAC - Ph2
n=1 Participants
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
|
|---|---|---|---|---|---|
|
Area Under the Ulocuplumab Concentration-time Curve From Time Zero to the Last Quantifiable Concentration [AUC(0-T)] - Phases 1 and 2
|
9455.529 µg.h/mL
Geometric Coefficient of Variation 10
|
21158.725 µg.h/mL
Geometric Coefficient of Variation 9
|
8152.698 µg.h/mL
Geometric Coefficient of Variation 50
|
13744.382 µg.h/mL
Geometric Coefficient of Variation 37
|
16502.463 µg.h/mL
Geometric Coefficient of Variation NA
Not applicable as n=1
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1Population: All treated participants who have evaluable PK profiles
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
Outcome measures
| Measure |
ULO 600mg + LDAC - Ph1
n=3 Participants
Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
ULO 800mg + LDAC - Ph1
n=3 Participants
Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
LDAC - Ph2
n=13 Participants
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
|
ULO 1000mg + LDAC - Ph2
n=7 Participants
Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
|
LDAC - Ph2
n=1 Participants
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
|
|---|---|---|---|---|---|
|
Area Under the Ulocuplumab Concentration-time Curve in One Dosing Interval [AUC(TAU)] - Phases 1 and 2
|
9455.529 µg.h/mL
Geometric Coefficient of Variation 10
|
21158.725 µg.h/mL
Geometric Coefficient of Variation 9
|
10082.624 µg.h/mL
Geometric Coefficient of Variation 38
|
13826.833 µg.h/mL
Geometric Coefficient of Variation 36
|
14257.807 µg.h/mL
Geometric Coefficient of Variation NA
Not applicable as n=1
|
SECONDARY outcome
Timeframe: 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)Population: 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
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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)Population: 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
The Pharmacokinetic (PK) parameters are assessed for ulocuplumab following study drug administration. EOT = end of treatment T-HALF determined as 0.693/λz
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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)Population: 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
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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)Population: 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
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first dose until a minimum follow-up of up to 2 monthsPopulation: All randomized participants
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
Outcome measures
| Measure |
ULO 600mg + LDAC - Ph1
n=26 Participants
Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
ULO 800mg + LDAC - Ph1
n=14 Participants
Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
LDAC - 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
|
ULO 1000mg + LDAC - Ph2
Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
|
LDAC - 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
|
|---|---|---|---|---|---|
|
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
|
19.2 Percentage of participants
Interval 6.6 to 39.4
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose until a minimum follow-up of up to 2 monthsPopulation: All randomized participants with CR/CRi
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.
Outcome measures
| Measure |
ULO 600mg + LDAC - Ph1
n=4 Participants
Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
ULO 800mg + LDAC - Ph1
n=1 Participants
Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
LDAC - 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
|
ULO 1000mg + LDAC - Ph2
Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
|
LDAC - 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
|
|---|---|---|---|---|---|
|
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
|
2.4 Months
Interval 0.5 to 5.6
|
4.3 Months
Only 1 participant
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose until a minimum follow-up of up to 2 monthsPopulation: All randomized participants
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
Outcome measures
| Measure |
ULO 600mg + LDAC - Ph1
n=24 Participants
Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
ULO 800mg + LDAC - Ph1
Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
LDAC - 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
|
ULO 1000mg + LDAC - Ph2
Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
|
LDAC - 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
|
|---|---|---|---|---|---|
|
Rate of Complete Remission (CR/CRi) and Overall Rate of Remission in Participants Treated With LDAC Only - Phase 2
CR/CRi
|
25.0 Percentage of participants
Interval 9.8 to 46.7
|
—
|
—
|
—
|
—
|
|
Rate of Complete Remission (CR/CRi) and Overall Rate of Remission in Participants Treated With LDAC Only - Phase 2
Overall remission rate
|
25.0 Percentage of participants
Interval 9.8 to 46.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose until a minimum follow-up of up to 2 monthsPopulation: All randomized participants with CR/CRi
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.
Outcome measures
| Measure |
ULO 600mg + LDAC - Ph1
n=6 Participants
Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
ULO 800mg + LDAC - Ph1
Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
LDAC - 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
|
ULO 1000mg + LDAC - Ph2
Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
|
LDAC - 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
|
|---|---|---|---|---|---|
|
Duration of Response in Participants With CR/CRi Treated With LDAC Only - Phase 2
|
5.7 Months
Interval 0.9 to
upper limit not reached
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose until a minimum follow-up of up to 2 monthsPopulation: All treated participants
Change from baseline of ECG endpoints Heart rate measured in beats per minute (bpm)
Outcome measures
| Measure |
ULO 600mg + LDAC - Ph1
n=3 Participants
Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
ULO 800mg + LDAC - Ph1
n=3 Participants
Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
LDAC - Ph2
n=15 Participants
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
|
ULO 1000mg + LDAC - Ph2
n=13 Participants
Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
|
LDAC - Ph2
n=9 Participants
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
|
|---|---|---|---|---|---|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: Heart Rate - Phases 1 and 2
Cycle 13, Day 1
|
-9.0 change from baseline bpm
|
—
|
8.0 change from baseline bpm
Standard Deviation NA
Not applicable as n=1
|
—
|
4.0 change from baseline bpm
Standard Deviation 2.8
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: Heart Rate - Phases 1 and 2
Cycle 2 Day 1
|
26.0 change from baseline bpm
Standard Deviation 63.6
|
4.0 change from baseline bpm
Standard Deviation 18.4
|
1.8 change from baseline bpm
Standard Deviation 11.3
|
-0.9 change from baseline bpm
Standard Deviation 20.0
|
-3.0 change from baseline bpm
Standard Deviation 7.6
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: Heart Rate - Phases 1 and 2
Cycle 3, Day 1
|
-2.3 change from baseline bpm
Standard Deviation 18.8
|
0.0 change from baseline bpm
Standard Deviation 15.6
|
5.8 change from baseline bpm
Standard Deviation 14.2
|
12.7 change from baseline bpm
Standard Deviation 14.3
|
1.7 change from baseline bpm
Standard Deviation 10.2
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: Heart Rate - Phases 1 and 2
Cycle 4, Day 1
|
-1.0 change from baseline bpm
|
-16.0 change from baseline bpm
Standard Deviation 5.7
|
-0.1 change from baseline bpm
Standard Deviation 9.9
|
11.0 change from baseline bpm
Standard Deviation 40.6
|
1.3 change from baseline bpm
Standard Deviation 16.7
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: Heart Rate - Phases 1 and 2
Cycle 5, Day 1
|
-6.0 change from baseline bpm
|
1.5 change from baseline bpm
Standard Deviation 7.8
|
4.3 change from baseline bpm
Standard Deviation 12.3
|
10.5 change from baseline bpm
Standard Deviation 2.1
|
8.8 change from baseline bpm
Standard Deviation 27.5
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: Heart Rate - Phases 1 and 2
Cycle 6, Day 1
|
-6.0 change from baseline bpm
|
-6.0 change from baseline bpm
Standard Deviation 16.5
|
6.8 change from baseline bpm
Standard Deviation 5.3
|
—
|
7.4 change from baseline bpm
Standard Deviation 14.9
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: Heart Rate - Phases 1 and 2
Cycle 7, Day 1
|
—
|
-11.7 change from baseline bpm
Standard Deviation 18.6
|
-3.5 change from baseline bpm
Standard Deviation 5.9
|
12.0 change from baseline bpm
Standard Deviation NA
Not applicable as n=1
|
6.5 change from baseline bpm
Standard Deviation 13.5
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: Heart Rate - Phases 1 and 2
Cycle 8, Day 1
|
-1.0 change from baseline bpm
|
—
|
0.7 change from baseline bpm
Standard Deviation 2.1
|
11.0 change from baseline bpm
Standard Deviation NA
Not applicable as n=1
|
0.8 change from baseline bpm
Standard Deviation 11.4
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: Heart Rate - Phases 1 and 2
Cycle 9, Day 1
|
—
|
-17.0 change from baseline bpm
Standard Deviation 11.3
|
7.0 change from baseline bpm
Standard Deviation 7.1
|
3.0 change from baseline bpm
Standard Deviation NA
Not applicable as n=1
|
0.6 change from baseline bpm
Standard Deviation 8.9
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: Heart Rate - Phases 1 and 2
Cycle 10, Day 1
|
-3.0 change from baseline bpm
|
-16.0 change from baseline bpm
Standard Deviation NA
Not applicable as n=1
|
9.3 change from baseline bpm
Standard Deviation 5.1
|
—
|
2.0 change from baseline bpm
Standard Deviation 1.4
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: Heart Rate - Phases 1 and 2
Cycle 11, Day 1
|
-12.0 change from baseline bpm
|
—
|
—
|
10.0 change from baseline bpm
Standard Deviation NA
Not applicable as n=1
|
-0.3 change from baseline bpm
Standard Deviation 6.7
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: Heart Rate - Phases 1 and 2
Cycle 12, Day 1
|
—
|
—
|
5.0 change from baseline bpm
Standard Deviation NA
Not applicable as n=1
|
19.0 change from baseline bpm
Standard Deviation NA
Not applicable as n=1
|
7.0 change from baseline bpm
Standard Deviation 2.8
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: Heart Rate - Phases 1 and 2
Cycle 14, Day 1
|
—
|
—
|
14.0 change from baseline bpm
Standard Deviation NA
Not applicable as n=1
|
—
|
—
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: Heart Rate - Phases 1 and 2
Cycle 15, Day 1
|
-10.0 change from baseline bpm
|
—
|
—
|
—
|
8.0 change from baseline bpm
Standard Deviation NA
Not applicable as n=1
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: Heart Rate - Phases 1 and 2
Cycle 16, Day 1
|
—
|
—
|
—
|
—
|
18.0 change from baseline bpm
Standard Deviation NA
Not applicable as n=1
|
SECONDARY outcome
Timeframe: From first dose until a minimum follow-up of up to 2 monthsPopulation: All treated participants
Change from baseline of ECG endpoints PR interval measured in milliseconds (msec)
Outcome measures
| Measure |
ULO 600mg + LDAC - Ph1
n=3 Participants
Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
ULO 800mg + LDAC - Ph1
n=3 Participants
Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
LDAC - Ph2
n=15 Participants
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
|
ULO 1000mg + LDAC - Ph2
n=10 Participants
Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
|
LDAC - Ph2
n=9 Participants
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
|
|---|---|---|---|---|---|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: PR Interval - Phases 1 and 2
Cycle 3, Day 1
|
8.0 change from baseline msec
Standard Deviation 6.0
|
-12.0 change from baseline msec
Standard Deviation 0.0
|
-5.3 change from baseline msec
Standard Deviation 26.2
|
-2.8 change from baseline msec
Standard Deviation 8.4
|
-1.9 change from baseline msec
Standard Deviation 7.5
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: PR Interval - Phases 1 and 2
Cycle 2 Day 1
|
4.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
-14.0 change from baseline msec
Standard Deviation 19.8
|
1.1 change from baseline msec
Standard Deviation 23.9
|
-5.1 change from baseline msec
Standard Deviation 9.9
|
1.2 change from baseline msec
Standard Deviation 5.3
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: PR Interval - Phases 1 and 2
Cycle 4, Day 1
|
14.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
-13.0 change from baseline msec
Standard Deviation 1.4
|
-16.3 change from baseline msec
Standard Deviation 28.4
|
-10.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
-11.9 change from baseline msec
Standard Deviation 15.7
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: PR Interval - Phases 1 and 2
Cycle 5, Day 1
|
-2.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
-16.0 change from baseline msec
Standard Deviation 2.8
|
-7.6 change from baseline msec
Standard Deviation 24.5
|
-11.0 change from baseline msec
Standard Deviation 7.1
|
-24.6 change from baseline msec
Standard Deviation 7.2
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: PR Interval - Phases 1 and 2
Cycle 6, Day 1
|
-44.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
-19.3 change from baseline msec
Standard Deviation 9.2
|
-12.8 change from baseline msec
Standard Deviation 21.8
|
—
|
-3.4 change from baseline msec
Standard Deviation 19.5
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: PR Interval - Phases 1 and 2
Cycle 7, Day 1
|
—
|
-17.3 change from baseline msec
Standard Deviation 9.5
|
-6.8 change from baseline msec
Standard Deviation 12.0
|
-2.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
-8.3 change from baseline msec
Standard Deviation 20.9
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: PR Interval - Phases 1 and 2
Cycle 8, Day 1
|
4.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
—
|
-5.3 change from baseline msec
Standard Deviation 27.2
|
-6.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
-9.4 change from baseline msec
Standard Deviation 16.2
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: PR Interval - Phases 1 and 2
Cycle 9, Day 1
|
—
|
-10.0 change from baseline msec
Standard Deviation 0.0
|
-17.0 change from baseline msec
Standard Deviation 46.7
|
6.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
0.6 change from baseline msec
Standard Deviation 8.5
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: PR Interval - Phases 1 and 2
Cycle 10, Day 1
|
-4.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
-2.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
-11.3 change from baseline msec
Standard Deviation 30.1
|
—
|
1.0 change from baseline msec
Standard Deviation 1.4
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: PR Interval - Phases 1 and 2
Cycle 11, Day 1
|
4.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
—
|
—
|
4.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
-1.7 change from baseline msec
Standard Deviation 12.7
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: PR Interval - Phases 1 and 2
Cycle 12, Day 1
|
—
|
—
|
-60.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
-4.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
-5.0 change from baseline msec
Standard Deviation 1.4
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: PR Interval - Phases 1 and 2
Cycle 13, Day 1
|
-2.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
—
|
-44.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
—
|
3.0 change from baseline msec
Standard Deviation 1.4
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: PR Interval - Phases 1 and 2
Cycle 14, Day 1
|
—
|
—
|
-54.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
—
|
—
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: PR Interval - Phases 1 and 2
Cycle 15, Day 1
|
0.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
—
|
—
|
—
|
-10.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: PR Interval - Phases 1 and 2
Cycle 16, Day 1
|
—
|
—
|
—
|
—
|
-2.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
SECONDARY outcome
Timeframe: From first dose until a minimum follow-up of up to 2 monthsPopulation: All treated participants
Change from baseline of ECG endpoints QRS interval measured in milliseconds (msec)
Outcome measures
| Measure |
ULO 600mg + LDAC - Ph1
n=3 Participants
Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
ULO 800mg + LDAC - Ph1
n=3 Participants
Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
LDAC - Ph2
n=15 Participants
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
|
ULO 1000mg + LDAC - Ph2
n=13 Participants
Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
|
LDAC - Ph2
n=9 Participants
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
|
|---|---|---|---|---|---|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: QRS Interval - Phases 1 and 2
Cycle 4, Day 1
|
0.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
1.0 change from baseline msec
Standard Deviation 1.4
|
2.7 change from baseline msec
Standard Deviation 8.8
|
-3.3 change from baseline msec
Standard Deviation 6.1
|
6.4 change from baseline msec
Standard Deviation 16.1
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: QRS Interval - Phases 1 and 2
Cycle 7, Day 1
|
—
|
-2.7 change from baseline msec
Standard Deviation 4.2
|
-3.3 change from baseline msec
Standard Deviation 7.0
|
-10.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
-1.5 change from baseline msec
Standard Deviation 4.9
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: QRS Interval - Phases 1 and 2
Cycle 8, Day 1
|
2.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
—
|
0.7 change from baseline msec
Standard Deviation 2.3
|
-8.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
2.6 change from baseline msec
Standard Deviation 6.9
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: QRS Interval - Phases 1 and 2
Cycle 9, Day 1
|
—
|
-1.0 change from baseline msec
Standard Deviation 1.4
|
-2.0 change from baseline msec
Standard Deviation 8.5
|
-6.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
0.0 change from baseline msec
Standard Deviation 3.2
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: QRS Interval - Phases 1 and 2
Cycle 2 Day 1
|
0.0 change from baseline msec
Standard Deviation 5.7
|
-2.0 change from baseline msec
Standard Deviation 5.7
|
5.1 change from baseline msec
Standard Deviation 11.3
|
0.5 change from baseline msec
Standard Deviation 9.6
|
4.8 change from baseline msec
Standard Deviation 12.5
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: QRS Interval - Phases 1 and 2
Cycle 3, Day 1
|
3.3 change from baseline msec
Standard Deviation 7.6
|
-2.0 change from baseline msec
Standard Deviation 5.7
|
-1.3 change from baseline msec
Standard Deviation 7.6
|
2.0 change from baseline msec
Standard Deviation 3.4
|
1.4 change from baseline msec
Standard Deviation 8.2
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: QRS Interval - Phases 1 and 2
Cycle 5, Day 1
|
8.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
-4.0 change from baseline msec
Standard Deviation 2.8
|
1.8 change from baseline msec
Standard Deviation 9.5
|
2.0 change from baseline msec
Standard Deviation 5.7
|
-1.4 change from baseline msec
Standard Deviation 2.4
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: QRS Interval - Phases 1 and 2
Cycle 6, Day 1
|
6.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
-2.7 change from baseline msec
Standard Deviation 4.2
|
-1.8 change from baseline msec
Standard Deviation 6.2
|
—
|
5.4 change from baseline msec
Standard Deviation 14.7
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: QRS Interval - Phases 1 and 2
Cycle 10, Day 1
|
2.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
-4.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
-2.3 change from baseline msec
Standard Deviation 8.6
|
—
|
9.5 change from baseline msec
Standard Deviation 4.9
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: QRS Interval - Phases 1 and 2
Cycle 11, Day 1
|
6.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
—
|
—
|
-4.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
9.0 change from baseline msec
Standard Deviation 7.5
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: QRS Interval - Phases 1 and 2
Cycle 12, Day 1
|
—
|
—
|
-6.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
-8.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
10.0 change from baseline msec
Standard Deviation 5.7
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: QRS Interval - Phases 1 and 2
Cycle 13, Day 1
|
2.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
—
|
-12.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
—
|
3.5 change from baseline msec
Standard Deviation 10.6
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: QRS Interval - Phases 1 and 2
Cycle 14, Day 1
|
—
|
—
|
-10.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
—
|
—
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: QRS Interval - Phases 1 and 2
Cycle 15, Day 1
|
6.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
—
|
—
|
—
|
8.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: QRS Interval - Phases 1 and 2
Cycle 16, Day 1
|
—
|
—
|
—
|
—
|
7.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
SECONDARY outcome
Timeframe: From first dose until a minimum follow-up of up to 2 monthsPopulation: All treated participants
Change from baseline of ECG endpoints QT interval measured in milliseconds (msec)
Outcome measures
| Measure |
ULO 600mg + LDAC - Ph1
n=3 Participants
Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
ULO 800mg + LDAC - Ph1
n=3 Participants
Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
LDAC - Ph2
n=15 Participants
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
|
ULO 1000mg + LDAC - Ph2
n=13 Participants
Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
|
LDAC - Ph2
n=9 Participants
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
|
|---|---|---|---|---|---|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: QT Interval - Phases 1 and 2
Cycle 2 Day 1
|
-41.0 change from baseline msec
Standard Deviation 94.8
|
-5.0 change from baseline msec
Standard Deviation 7.1
|
4.5 change from baseline msec
Standard Deviation 25.5
|
10.4 change from baseline msec
Standard Deviation 50.1
|
14.2 change from baseline msec
Standard Deviation 33.7
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: QT Interval - Phases 1 and 2
Cycle 3, Day 1
|
10.0 change from baseline msec
Standard Deviation 36.7
|
7.0 change from baseline msec
Standard Deviation 29.7
|
-15.4 change from baseline msec
Standard Deviation 30.6
|
-10.7 change from baseline msec
Standard Deviation 41.3
|
13.7 change from baseline msec
Standard Deviation 41.7
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: QT Interval - Phases 1 and 2
Cycle 4, Day 1
|
-60.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
35.0 change from baseline msec
Standard Deviation 32.5
|
10.1 change from baseline msec
Standard Deviation 22.8
|
-12.7 change from baseline msec
Standard Deviation 104.3
|
-1.4 change from baseline msec
Standard Deviation 47.9
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: QT Interval - Phases 1 and 2
Cycle 5, Day 1
|
12.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
13.0 change from baseline msec
Standard Deviation 15.6
|
2.2 change from baseline msec
Standard Deviation 32.1
|
-5.0 change from baseline msec
Standard Deviation 26.9
|
-27.6 change from baseline msec
Standard Deviation 75.5
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: QT Interval - Phases 1 and 2
Cycle 6, Day 1
|
2.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
6.0 change from baseline msec
Standard Deviation 26.9
|
-11.8 change from baseline msec
Standard Deviation 19.1
|
—
|
-3.6 change from baseline msec
Standard Deviation 39.3
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: QT Interval - Phases 1 and 2
Cycle 7, Day 1
|
—
|
29.3 change from baseline msec
Standard Deviation 20.0
|
11.8 change from baseline msec
Standard Deviation 13.6
|
-8.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
-8.8 change from baseline msec
Standard Deviation 28.3
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: QT Interval - Phases 1 and 2
Cycle 8, Day 1
|
2.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
—
|
2.0 change from baseline msec
Standard Deviation 2.0
|
-24.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
0.8 change from baseline msec
Standard Deviation 35.5
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: QT Interval - Phases 1 and 2
Cycle 9, Day 1
|
—
|
37.0 change from baseline msec
Standard Deviation 9.9
|
-23.0 change from baseline msec
Standard Deviation 21.2
|
-14.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
-24.4 change from baseline msec
Standard Deviation 23.0
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: QT Interval - Phases 1 and 2
Cycle 10, Day 1
|
6.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
14.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
-18.3 change from baseline msec
Standard Deviation 18.6
|
—
|
-6.0 change from baseline msec
Standard Deviation 11.3
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: QT Interval - Phases 1 and 2
Cycle 11, Day 1
|
16.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
—
|
—
|
-22.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
7.0 change from baseline msec
Standard Deviation 2.6
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: QT Interval - Phases 1 and 2
Cycle 12, Day 1
|
—
|
—
|
-4.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
-36.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
-6.5 change from baseline msec
Standard Deviation 27.6
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: QT Interval - Phases 1 and 2
Cycle 13, Day 1
|
20.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
—
|
-40.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
—
|
-15.0 change from baseline msec
Standard Deviation 18.4
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: QT Interval - Phases 1 and 2
Cycle 14, Day 1
|
—
|
—
|
-44.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
—
|
—
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: QT Interval - Phases 1 and 2
Cycle 15, Day 1
|
36.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
—
|
—
|
—
|
-19.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
|
Change From Baseline of Electrocardiogram (ECG) Endpoints: QT Interval - Phases 1 and 2
Cycle 16, Day 1
|
—
|
—
|
—
|
—
|
-105.0 change from baseline msec
Standard Deviation NA
Not applicable as n=1
|
SECONDARY outcome
Timeframe: From first dose until a minimum follow-up of up to 2 monthsPopulation: All treated participants for phase 2. Phase 1 OS data not collected.
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.
Outcome measures
| Measure |
ULO 600mg + LDAC - Ph1
Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
ULO 800mg + LDAC - Ph1
Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
LDAC - Ph2
n=26 Participants
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
|
ULO 1000mg + LDAC - Ph2
n=14 Participants
Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
|
LDAC - Ph2
n=22 Participants
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
|
|---|---|---|---|---|---|
|
Overall Survival (OS) - Phases 1 and 2
|
—
|
—
|
3.3 Months
Interval 1.8 to 8.7
|
3.0 Months
Interval 1.8 to 4.7
|
6.9 Months
Interval 1.6 to 12.7
|
Adverse Events
Ulo 600mg+LDAC
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Ulo 800mg+LDAC
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Ulocuplumab 800mg + LDAC 20mg BID
Serious events: 21 serious events
Other events: 25 other events
Deaths: 19 deaths
Ulocuplumab 1000mg + LDAC 20mg BID
Serious events: 8 serious events
Other events: 14 other events
Deaths: 10 deaths
LDAC 20mg BID
Serious events: 15 serious events
Other events: 22 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
Ulo 600mg+LDAC
n=3 participants at risk
Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
Ulo 800mg+LDAC
n=3 participants at risk
Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
Ulocuplumab 800mg + LDAC 20mg BID
n=26 participants at risk
Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
|
Ulocuplumab 1000mg + LDAC 20mg BID
n=14 participants at risk
Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
|
LDAC 20mg BID
n=22 participants at risk
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.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
66.7%
2/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
30.8%
8/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
35.7%
5/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
27.3%
6/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Cardiac disorders
Cardiac failure
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Eye disorders
Cataract
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.7%
2/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
9.1%
2/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.7%
2/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
General disorders
Complication associated with device
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
General disorders
Death
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
General disorders
Fatigue
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.7%
2/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
11.5%
3/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
11.5%
3/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
14.3%
2/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Infections and infestations
Septic shock
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Investigations
Amylase increased
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Epstein-Barr virus associated lymphoproliferative disorder
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
19.2%
5/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
14.3%
2/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
27.3%
6/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.7%
2/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Vascular disorders
Neurogenic shock
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
Other adverse events
| Measure |
Ulo 600mg+LDAC
n=3 participants at risk
Ulocuplumab (ULO) at 600mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
Ulo 800mg+LDAC
n=3 participants at risk
Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 1 (Ph1)
|
Ulocuplumab 800mg + LDAC 20mg BID
n=26 participants at risk
Ulocuplumab (ULO) at 800mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
|
Ulocuplumab 1000mg + LDAC 20mg BID
n=14 participants at risk
Ulocuplumab (ULO) at 1000mg + low dose cytarabine (LDAC) - Phase 2 (Ph2)
|
LDAC 20mg BID
n=22 participants at risk
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.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.7%
2/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Blood and lymphatic system disorders
Anaemia
|
66.7%
2/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
100.0%
3/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
42.3%
11/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
21.4%
3/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
36.4%
8/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
100.0%
3/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
19.2%
5/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
28.6%
4/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
31.8%
7/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
15.4%
4/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
23.1%
6/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
9.1%
2/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Cardiac disorders
Atrial fibrillation
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.7%
2/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
13.6%
3/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.7%
2/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Eye disorders
Dry eye
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
9.1%
2/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
38.5%
10/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
14.3%
2/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
22.7%
5/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
23.1%
6/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
21.4%
3/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
22.7%
5/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.7%
2/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.7%
2/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Gastrointestinal disorders
Haemorrhoids
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
9.1%
2/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
14.3%
2/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
66.7%
2/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
23.1%
6/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
57.1%
8/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
27.3%
6/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Gastrointestinal disorders
Periodontal disease
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Gastrointestinal disorders
Stomatitis
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
100.0%
3/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
19.2%
5/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
21.4%
3/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
18.2%
4/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
15.4%
4/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
13.6%
3/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
General disorders
Asthenia
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
11.5%
3/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
9.1%
2/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
General disorders
Catheter site erythema
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.7%
2/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
General disorders
Chills
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
21.4%
3/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
9.1%
2/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
General disorders
Early satiety
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
General disorders
Fatigue
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
19.2%
5/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
28.6%
4/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
22.7%
5/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
General disorders
Generalised oedema
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
General disorders
Malaise
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
11.5%
3/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
General disorders
Mass
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.7%
2/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
14.3%
2/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
General disorders
Oedema peripheral
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
66.7%
2/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
23.1%
6/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
18.2%
4/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
General disorders
Pyrexia
|
66.7%
2/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
66.7%
2/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
30.8%
8/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
35.7%
5/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
22.7%
5/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Hepatobiliary disorders
Hepatic congestion
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.7%
2/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Hepatobiliary disorders
Hepatosplenomegaly
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Immune system disorders
Hypersensitivity
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
14.3%
2/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Infections and infestations
Device related infection
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
9.1%
2/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
14.3%
2/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Infections and infestations
Herpes simplex
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Infections and infestations
Herpes zoster
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
13.6%
3/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
9.1%
2/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Infections and infestations
Otitis media
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Infections and infestations
Skin infection
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Infections and infestations
Subcutaneous abscess
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
9.1%
2/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Injury, poisoning and procedural complications
Allergic transfusion reaction
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
9.1%
2/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
14.3%
2/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
9.1%
2/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.7%
2/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
9.1%
2/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Investigations
Amylase increased
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.7%
2/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
11.5%
3/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
9.1%
2/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Investigations
Lipase increased
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.7%
2/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
9.1%
2/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Investigations
Neutrophil count decreased
|
66.7%
2/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
11.5%
3/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
27.3%
6/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Investigations
Platelet count decreased
|
66.7%
2/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
100.0%
3/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
23.1%
6/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
28.6%
4/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
36.4%
8/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Investigations
Troponin T increased
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Investigations
Weight decreased
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
9.1%
2/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
19.2%
5/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
13.6%
3/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
11.5%
3/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
14.3%
2/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
18.2%
4/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.7%
2/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
9.1%
2/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
9.1%
2/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.7%
2/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.7%
2/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
21.4%
3/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
13.6%
3/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
11.5%
3/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.7%
2/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
14.3%
2/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.7%
2/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
9.1%
2/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
66.7%
2/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
28.6%
4/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
14.3%
2/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
13.6%
3/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.7%
2/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
9.1%
2/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
11.5%
3/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
21.4%
3/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
9.1%
2/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
14.3%
2/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.7%
2/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
26.9%
7/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Renal and urinary disorders
Acute kidney injury
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Renal and urinary disorders
Renal tubular disorder
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Reproductive system and breast disorders
Genital ulceration
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
66.7%
2/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
23.1%
6/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
21.4%
3/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
9.1%
2/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
19.2%
5/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
28.6%
4/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.7%
2/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
11.5%
3/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
14.3%
2/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
3.8%
1/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
11.5%
3/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
14.3%
2/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
14.3%
2/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Skin and subcutaneous tissue disorders
Acute febrile neutrophilic dermatosis
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
9.1%
2/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
9.1%
2/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
14.3%
2/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.7%
2/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
14.3%
2/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
21.4%
3/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
9.1%
2/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.7%
2/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
9.1%
2/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Vascular disorders
Haematoma
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.7%
2/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
11.5%
3/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
14.3%
2/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
4.5%
1/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
7.1%
1/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
|
Vascular disorders
Vasculitis
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/3 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
11.5%
3/26 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/14 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
0.00%
0/22 • Includes on-treatment events from first dose to within 100 days of last dose
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.
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email:
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60