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NCT00441337 · STUDY IN CONTEXT

A Study of MDX-1106 in Patients With Selected Refractory or Relapsed Malignancies

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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

AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Severe=All Grade 3 or 4 events. Death=during the study and up to 28 days past study discontinuation. AEs graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. irAEs=unknown etiology, associated with study drug and consistent with an immune phenomenon. DLT: ≥Gr 3 AE(s) or lab abnormality without alternative explanation other than drug.

Safety Population: All participants who received at least 1 dose or any partial dose of nivolumab were analyzed.

primary · POSTED

Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated enzyme-linked immunosorbent assay (ELISA) method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The pharmacokinetic (PK) parameter of Cmax was measured in micrograms per milliliter (µg/mL).

All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics.

primary · POSTED

Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The PK parameter of Tmax was measured in hours (h).

All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics.

primary · POSTED

AUC(0-T): Area under the concentration-time curve from the time of dosing to the time of the last observation. AUC(INF): Area under the curve from the time of dosing extrapolated to infinity. Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The PK parameters of AUC(0-T) and AUC (INF) were measured in micrograms\hours per milliliter (µg\h/mL).

All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics.

primary · POSTED

Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The PK parameter of T-HALF was measured in days.

All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics.

primary · POSTED

Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The PK parameter of CLT was measured in milliliters per hour per kilogram body weight (mL/h/kg).

All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics.

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-prostate-cancer
nct id: NCT00441337
trial label: A Study of MDX-1106 in Patients With Selected Refractory or Relapsed Malignancies
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
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: 4
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00441337
outcome key
om-0000
source section id
NCT00441337-om-0000
source outcome index
0
endpoint
Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Drug-Related AEs, Deaths, Discontinuation of Study Drug Due to AE, Dose-Limiting Toxicity (DLT) AE and Immune-related AEs (irAEs) in Safety Population
endpoint definition
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Severe=All Grade 3 or 4 events. Death=during the study and up to 28 days past study discontinuation. AEs graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. irAEs=unknown etiology, associated with study drug and consistent with an immune phenomenon. DLT: ≥Gr 3 AE(s) or lab abnormality without alternative explanation other than drug.
time origin
Day 1 to 70 days post last dose of study drug; 28 days past study discontinuation
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Safety Population: All participants who received at least 1 dose or any partial dose of nivolumab were analyzed.
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-prostate-cancer
nct id
NCT00441337
outcome key
om-0001
source section id
NCT00441337-om-0001
source outcome index
1
endpoint
Geometric Mean Maximum Serum Concentration (Cmax) Observed Post-Single Dose
endpoint definition
Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated enzyme-linked immunosorbent assay (ELISA) method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The pharmacokinetic (PK) parameter of Cmax was measured in micrograms per milliliter (µg/mL).
time origin
Day 1 to Day 85
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics.
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-prostate-cancer
nct id
NCT00441337
outcome key
om-0002
source section id
NCT00441337-om-0002
source outcome index
2
endpoint
Median Time at Which the Maximum Serum Concentration Occurred (Tmax) Post-Single Dose
endpoint definition
Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The PK parameter of Tmax was measured in hours (h).
time origin
Day 1 to Day 85
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics.
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-prostate-cancer
nct id
NCT00441337
outcome key
om-0003
source section id
NCT00441337-om-0003
source outcome index
3
endpoint
Geometric Mean Area Under the Curve (AUC) From Time of Dosing to Time of Last Observation (0-T) and Extrapolated to Infinity (INF) Observed Post-Single Dose
endpoint definition
AUC(0-T): Area under the concentration-time curve from the time of dosing to the time of the last observation. AUC(INF): Area under the curve from the time of dosing extrapolated to infinity. Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The PK parameters of AUC(0-T) and AUC (INF) were measured in micrograms\*hours per milliliter (µg\*h/mL).
time origin
Day 1 to Day 85
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics.
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-prostate-cancer
nct id
NCT00441337
outcome key
om-0004
source section id
NCT00441337-om-0004
source outcome index
4
endpoint
Mean Elimination Half-life (T-HALF) Post-Single Dose
endpoint definition
Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The PK parameter of T-HALF was measured in days.
time origin
Day 1 to Day 85
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics.
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-prostate-cancer
nct id
NCT00441337
outcome key
om-0005
source section id
NCT00441337-om-0005
source outcome index
5
endpoint
Geometric Mean Total Body Clearance of Drug From Serum (CLT) Post-Single Dose
endpoint definition
Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The PK parameter of CLT was measured in milliliters per hour per kilogram body weight (mL/h/kg).
time origin
Day 1 to Day 85
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics.
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-prostate-cancer
nct id
NCT00441337
outcome key
om-0000
arm key
OG000
arm label
0.3 mg/kg Nivolumab
regimen
0.3 mg of nivolumab per kg of body weight (mg/kg) was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00441337-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00441337
outcome key
om-0000
arm key
OG001
arm label
1 mg/kg Nivolumab
regimen
1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00441337-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00441337
outcome key
om-0000
arm key
OG002
arm label
3 mg/kg Nivolumab
regimen
3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00441337-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00441337
outcome key
om-0000
arm key
OG003
arm label
10 mg/kg Nivolumab
regimen
10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
analyzed count
21
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00441337-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00441337
outcome key
om-0001
arm key
OG000
arm label
0.3 mg/kg Nivolumab
regimen
0.3 mg of nivolumab per kg of body weight (mg/kg) was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00441337-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00441337
outcome key
om-0001
arm key
OG001
arm label
1 mg/kg Nivolumab
regimen
1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00441337-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00441337
outcome key
om-0001
arm key
OG002
arm label
3 mg/kg Nivolumab
regimen
3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00441337-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00441337
outcome key
om-0001
arm key
OG003
arm label
10 mg/kg Nivolumab
regimen
10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
analyzed count
21
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00441337-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00441337
outcome key
om-0002
arm key
OG000
arm label
0.3 mg/kg Nivolumab
regimen
0.3 mg of nivolumab per kg of body weight (mg/kg) was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00441337-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00441337
outcome key
om-0002
arm key
OG001
arm label
1 mg/kg Nivolumab
regimen
1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00441337-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00441337
outcome key
om-0002
arm key
OG002
arm label
3 mg/kg Nivolumab
regimen
3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00441337-om-0002#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00441337
outcome key
om-0002
arm key
OG003
arm label
10 mg/kg Nivolumab
regimen
10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
analyzed count
21
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00441337-om-0002#groups/OG003

harms

release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00441337
harm key
EG000
source section id
NCT00441337-ae
event group key
EG000
event group label
0.3 mg/kg Nivolumab
serious affected
3
serious at risk
6
other affected
6
other at risk
6
frequency threshold
5
collection period
Day 1 through long-term follow-up until either progressive disease or 2 years elapsed.
event definition
Study was initiated in 2006 and completed in 2009
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-prostate-cancer
nct id
NCT00441337
harm key
EG001
source section id
NCT00441337-ae
event group key
EG001
event group label
1 mg/kg Nivolumab
serious affected
5
serious at risk
6
other affected
6
other at risk
6
frequency threshold
5
collection period
Day 1 through long-term follow-up until either progressive disease or 2 years elapsed.
event definition
Study was initiated in 2006 and completed in 2009
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-prostate-cancer
nct id
NCT00441337
harm key
EG002
source section id
NCT00441337-ae
event group key
EG002
event group label
3 mg/kg Nivolumab
serious affected
4
serious at risk
6
other affected
6
other at risk
6
frequency threshold
5
collection period
Day 1 through long-term follow-up until either progressive disease or 2 years elapsed.
event definition
Study was initiated in 2006 and completed in 2009
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-prostate-cancer
nct id
NCT00441337
harm key
EG003
source section id
NCT00441337-ae
event group key
EG003
event group label
10 mg/kg Nivolumab
serious affected
11
serious at risk
21
other affected
21
other at risk
21
frequency threshold
5
collection period
Day 1 through long-term follow-up until either progressive disease or 2 years elapsed.
event definition
Study was initiated in 2006 and completed in 2009
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
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created at
2026-09-10T00:00:00Z

quality of life

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