Safety and Dose Ranging Study of Samalizumab to Treat Relapsing or Refractory CLL or MM

Draft scope assessment: unclear. Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

The MTD was to be defined as the dose level at which less than one-third of participants experienced a dose-limiting toxicity (DLT) during the first 28 days of treatment and immediately below the dose at which at least one-third of participants experienced a DLT. A DLT was defined as any Grade 3 or greater toxicity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 not related to the disease under study or its sequelae that occurred in the first 28 days after dosing in Cycle 1. The NCI CTCAE grading system for the organ of involvement was used to classify severity of adverse autoimmune reactions.

All participants who received at least 1 dose of samalizumab.

→

primary · POSTED

A TEAE was defined as any event not present prior to exposure to samalizumab or any event already present that worsened in either intensity or frequency following exposure to samalizumab. A treatment-emergent serious adverse event was defined as any event that resulted in death, was immediately life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

All participants who received at least 1 dose of samalizumab.

→

secondary · POSTED

Bound samalizumab was detected using a monoclonal antibody (mAb) specific for samalizumab. The binding of samalizumab to CD200 on peripheral B-CLL tumor cells was evaluated in participants with B-CLL by flow cytometry and expressed as the percent of B-CLL cells bound by samalizumab. For participants with insufficient numbers of peripheral B-CLL for analysis, the samples were documented as "unevaluable" and an analysis was not performed.

All participants with B-CLL who had evaluable assessments for bound samalizumab were included in the analysis. No participants with B-CLL received samalizumab at the 600 mg/m\^2 dose level.

→

secondary · POSTED

Bound samalizumab was detected using a mAb specific for samalizumab. The binding of samalizumab to CD200 on peripheral B-CLL tumor cells was evaluated in participants with B-CLL by flow cytometry and expressed as mean channel fluorescence intensity (MFI) of bound samalizumab to provide an indication of the density of bound samalizumab on target B-CLL cells. For participants with insufficient numbers of peripheral B-CLL for analysis, the samples were documented as "unevaluable" and an analysis was not performed.

All participants with B-CLL who had evaluable assessments for bound samalizumab were included in the analysis. No participants with B-CLL received samalizumab at the 600 mg/m\^2 dose level.

→

secondary · POSTED

Clinical responses assessed using the Modified NCI Working Group Response Criteria. Overall Response Rate (ORR)=percentage of participants who maintained best response for ≥1 month after achieving that best response and having complete response (CR), partial response (PR), nodular partial response (nPR), or stable disease (SD). CR=absence of lymphadenopathy, hepatomegaly, or splenomegaly and normal complete blood count (CBC). PR=≥50% decrease in peripheral lymphocyte count or ≥50% reduction in lymphadenopathy, hepatomegaly, or splenomegaly and normal or 50% improvement over baseline CBC. nPR=CR participants with lymphoid aggregates. Progressive disease (PD)=\>50% increase for \>2 lymph nodes, spleen and/or liver size, or absolute number of circulating lymphocytes; or new lymph nodes. SD=have not achieved CR, PR, or nPR or have not shown PD. Features must be exhibited for ≥1month for CR/PR. Number of participants with individual best response and ORR for each cohort is presented.

All participants with B-CLL who received at least 1 dose of samalizumab.

→

secondary · POSTED

Clinical responses of samalizumab were assessed using the International Myeloma Working Group Uniform Response Criteria. ORR was defined as the percentage of participants who had either stringent complete response, complete response, very good partial response, or partial response on 2 consecutive assessments made at any time before the administration of any new therapy. The number of participants with the individual best response and ORR for each cohort is presented.

All participants with MM who received at least 1 dose of samalizumab.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-chronic-lymphocytic-leukemia-jaypirca-c16a5563
nct id: NCT00648739
trial label: Safety and Dose Ranging Study of Samalizumab to Treat Relapsing or Refractory CLL or MM
applicability: unclear
applicability note: Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 7
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-jaypirca-c16a5563
nct id
NCT00648739
outcome key
om-0000
source section id
NCT00648739-om-0000
source outcome index
0
endpoint
Maximum Tolerated Dose (MTD) Of Samalizumab
endpoint definition
The MTD was to be defined as the dose level at which less than one-third of participants experienced a dose-limiting toxicity (DLT) during the first 28 days of treatment and immediately below the dose at which at least one-third of participants experienced a DLT. A DLT was defined as any Grade 3 or greater toxicity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 not related to the disease under study or its sequelae that occurred in the first 28 days after dosing in Cycle 1. The NCI CTCAE grading system for the organ of involvement was used to classify severity of adverse autoimmune reactions.
time origin
From first dose through 10 weeks after the last dose
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All participants who received at least 1 dose of samalizumab.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-jaypirca-c16a5563
nct id
NCT00648739
outcome key
om-0001
source section id
NCT00648739-om-0001
source outcome index
1
endpoint
Number Of Participants With Treatment-Emergent Adverse Events (TEAEs)
endpoint definition
A TEAE was defined as any event not present prior to exposure to samalizumab or any event already present that worsened in either intensity or frequency following exposure to samalizumab. A treatment-emergent serious adverse event was defined as any event that resulted in death, was immediately life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
time origin
From first dose through 10 weeks after the last dose
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All participants who received at least 1 dose of samalizumab.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-jaypirca-c16a5563
nct id
NCT00648739
outcome key
om-0002
source section id
NCT00648739-om-0002
source outcome index
2
endpoint
Percent Of Bound Samalizumab On B-Cell Chronic Lymphocytic Leukemia (B-CLL) Cells In Participants With B-CLL At Baseline (Predose) And Day 1 (Postdose)
endpoint definition
Bound samalizumab was detected using a monoclonal antibody (mAb) specific for samalizumab. The binding of samalizumab to CD200 on peripheral B-CLL tumor cells was evaluated in participants with B-CLL by flow cytometry and expressed as the percent of B-CLL cells bound by samalizumab. For participants with insufficient numbers of peripheral B-CLL for analysis, the samples were documented as "unevaluable" and an analysis was not performed.
time origin
Baseline (Predose) and Day 1 (Postdose)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All participants with B-CLL who had evaluable assessments for bound samalizumab were included in the analysis. No participants with B-CLL received samalizumab at the 600 mg/m\^2 dose level.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-jaypirca-c16a5563
nct id
NCT00648739
outcome key
om-0003
source section id
NCT00648739-om-0003
source outcome index
3
endpoint
Density Of B-CLL Cells Bound At Baseline (Predose) And Day 1 (Postdose)
endpoint definition
Bound samalizumab was detected using a mAb specific for samalizumab. The binding of samalizumab to CD200 on peripheral B-CLL tumor cells was evaluated in participants with B-CLL by flow cytometry and expressed as mean channel fluorescence intensity (MFI) of bound samalizumab to provide an indication of the density of bound samalizumab on target B-CLL cells. For participants with insufficient numbers of peripheral B-CLL for analysis, the samples were documented as "unevaluable" and an analysis was not performed.
time origin
Baseline (Predose) and Day 1 (Postdose)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All participants with B-CLL who had evaluable assessments for bound samalizumab were included in the analysis. No participants with B-CLL received samalizumab at the 600 mg/m\^2 dose level.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-jaypirca-c16a5563
nct id
NCT00648739
outcome key
om-0004
source section id
NCT00648739-om-0004
source outcome index
4
endpoint
Clinical Response Of Participants With B-CLL Following Samalizumab Dosing Using Modified NCI Working Group Response Criteria For ORR Rate
endpoint definition
Clinical responses assessed using the Modified NCI Working Group Response Criteria. Overall Response Rate (ORR)=percentage of participants who maintained best response for ≥1 month after achieving that best response and having complete response (CR), partial response (PR), nodular partial response (nPR), or stable disease (SD). CR=absence of lymphadenopathy, hepatomegaly, or splenomegaly and normal complete blood count (CBC). PR=≥50% decrease in peripheral lymphocyte count or ≥50% reduction in lymphadenopathy, hepatomegaly, or splenomegaly and normal or 50% improvement over baseline CBC. nPR=CR participants with lymphoid aggregates. Progressive disease (PD)=\>50% increase for \>2 lymph nodes, spleen and/or liver size, or absolute number of circulating lymphocytes; or new lymph nodes. SD=have not achieved CR, PR, or nPR or have not shown PD. Features must be exhibited for ≥1month for CR/PR. Number of participants with individual best response and ORR for each cohort is presented.
time origin
From first dose through 10 weeks after the last dose
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All participants with B-CLL who received at least 1 dose of samalizumab.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-jaypirca-c16a5563
nct id
NCT00648739
outcome key
om-0005
source section id
NCT00648739-om-0005
source outcome index
5
endpoint
Clinical Response Of Participants With Multiple Myeloma (MM) Following Dosing With Samalizumab
endpoint definition
Clinical responses of samalizumab were assessed using the International Myeloma Working Group Uniform Response Criteria. ORR was defined as the percentage of participants who had either stringent complete response, complete response, very good partial response, or partial response on 2 consecutive assessments made at any time before the administration of any new therapy. The number of participants with the individual best response and ORR for each cohort is presented.
time origin
From first dose through 10 weeks after the last dose
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All participants with MM who received at least 1 dose of samalizumab.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-jaypirca-c16a5563
nct id
NCT00648739
outcome key
om-0000
arm key
OG000
arm label
Samalizumab
regimen
All doses of samalizumab were individualized based on the participant's body surface area in mg/m\^2 based on screening height and weight. Participants were assigned to a dose cohort, ranging from 50 to 600 mg/m\^2, and received a single IV dose of samalizumab. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
analyzed count
26
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00648739-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-jaypirca-c16a5563
nct id
NCT00648739
outcome key
om-0001
arm key
OG000
arm label
Samalizumab 50 mg/m^2
regimen
Participants assigned to this dose cohort received a single IV dose of samalizumab 50 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00648739-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-jaypirca-c16a5563
nct id
NCT00648739
outcome key
om-0001
arm key
OG001
arm label
Samalizumab 100 mg/m^2
regimen
Participants assigned to this dose cohort received a single IV dose of samalizumab 100 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00648739-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-jaypirca-c16a5563
nct id
NCT00648739
outcome key
om-0001
arm key
OG002
arm label
Samalizumab 200 mg/m^2
regimen
Participants assigned to this dose cohort received a single IV dose of samalizumab 200 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00648739-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-jaypirca-c16a5563
nct id
NCT00648739
outcome key
om-0001
arm key
OG003
arm label
Samalizumab 300 mg/m^2
regimen
Participants assigned to this dose cohort received a single IV dose of samalizumab 300 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00648739-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-jaypirca-c16a5563
nct id
NCT00648739
outcome key
om-0001
arm key
OG004
arm label
Samalizumab 400 mg/m^2
regimen
Participants assigned to this dose cohort received a single IV dose of samalizumab 400 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00648739-om-0001#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-jaypirca-c16a5563
nct id
NCT00648739
outcome key
om-0001
arm key
OG005
arm label
Samalizumab 500 mg/m^2
regimen
Participants assigned to this dose cohort received a single IV dose of samalizumab 500 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00648739-om-0001#groups/OG005
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-jaypirca-c16a5563
nct id
NCT00648739
outcome key
om-0001
arm key
OG006
arm label
Samalizumab 600 mg/m^2
regimen
Participants assigned to this dose cohort received a single IV dose of samalizumab 600 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00648739-om-0001#groups/OG006
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-jaypirca-c16a5563
nct id
NCT00648739
outcome key
om-0001
arm key
OG007
arm label
Overall
regimen
All doses of samalizumab were individualized based on the participant's body surface area in mg/m\^2 based on screening height and weight. Participants were assigned to a dose cohort, ranging from 50 to 600 mg/m\^2, and received a single IV dose of samalizumab. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
analyzed count
26
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00648739-om-0001#groups/OG007
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-jaypirca-c16a5563
nct id
NCT00648739
outcome key
om-0002
arm key
OG000
arm label
Samalizumab 50 mg/m^2
regimen
Participants assigned to this dose cohort received a single IV dose of samalizumab 50 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00648739-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-jaypirca-c16a5563
nct id
NCT00648739
outcome key
om-0002
arm key
OG001
arm label
Samalizumab 100 mg/m^2
regimen
Participants assigned to this dose cohort received a single IV dose of samalizumab 100 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00648739-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-jaypirca-c16a5563
nct id
NCT00648739
outcome key
om-0002
arm key
OG002
arm label
Samalizumab 200 mg/m^2
regimen
Participants assigned to this dose cohort received a single IV dose of samalizumab 200 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00648739-om-0002#groups/OG002

harms

release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-jaypirca-c16a5563
nct id
NCT00648739
harm key
EG000
source section id
NCT00648739-ae
event group key
EG000
event group label
Samalizumab 50 mg/m^2
serious affected
1
serious at risk
4
other affected
4
other at risk
4
frequency threshold
0
collection period
From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-jaypirca-c16a5563
nct id
NCT00648739
harm key
EG001
source section id
NCT00648739-ae
event group key
EG001
event group label
Samalizumab 100 mg/m^2
serious affected
2
serious at risk
5
other affected
5
other at risk
5
frequency threshold
0
collection period
From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-jaypirca-c16a5563
nct id
NCT00648739
harm key
EG002
source section id
NCT00648739-ae
event group key
EG002
event group label
Samalizumab 200 mg/m^2
serious affected
0
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-jaypirca-c16a5563
nct id
NCT00648739
harm key
EG003
source section id
NCT00648739-ae
event group key
EG003
event group label
Samalizumab 300 mg/m^2
serious affected
1
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-jaypirca-c16a5563
nct id
NCT00648739
harm key
EG004
source section id
NCT00648739-ae
event group key
EG004
event group label
Samalizumab 400 mg/m^2
serious affected
1
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-jaypirca-c16a5563
nct id
NCT00648739
harm key
EG005
source section id
NCT00648739-ae
event group key
EG005
event group label
Samalizumab 500 mg/m^2
serious affected
1
serious at risk
7
other affected
6
other at risk
7
frequency threshold
0
collection period
From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-jaypirca-c16a5563
nct id
NCT00648739
harm key
EG006
source section id
NCT00648739-ae
event group key
EG006
event group label
Samalizumab 600 mg/m^2
serious affected
0
serious at risk
1
other affected
1
other at risk
1
frequency threshold
0
collection period
From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice