Skip to content
Triangle logo TriangleGet started
← KEYTRUDA QLEX: unresectable metastatic Melanoma

NCT00094653 · STUDY IN CONTEXT

MDX-010 Antibody, MDX-1379 Melanoma Vaccine, or MDX-010/MDX-1379 Combination Treatment for Patients With Unresectable or Metastatic Melanoma

Draft scope assessment: unclear. Attached because the study's own record describes metastatic 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 because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

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

OS was defined as the time from randomization until death from any cause. If a participant did not expire, the subject was censored at the time of last contact (last known alive date). 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method.

Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.

→

secondary · POSTED

OS was defined as the time from randomization until death from any cause. If a participant did not expire, the subject was censored at the time of last contact (last known alive date). 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method.

Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.

→

secondary · POSTED

The probability that a subject is alive at 12 months, 18 months, and 24 months following randomization, estimated via the non-parametric method (Kaplan-Meier method). For calculating 95% CI, bootstrap method was used with 20000 simulated trials.

Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.

→

secondary · POSTED

PFS was defined as the number of days between the date of randomization and the date of the progression or the date of death. A subject who died without prior progression was considered to have progressed on the date of death. PFS was determined by investigator. 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method.

Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study. Subjects who neither progressed nor died were censored at the date of the last tumor assessment.

→

secondary · POSTED

PFS at Week 12 was defined as the probability that the subject was progression-free at 12 weeks and 24 weeks following the start of randomization. It was computed via Kaplan-Meier method, truncated at Week 12 and Week 24. PFS was determined by investigator. 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method.

Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.

→

secondary · POSTED

TTP was defined as the number of days between the date of the randomization and date of PD or death due to PD. For subjects who had not progression and remained alive, TTP was censored on the date of last assessment; those who remained alive and had no recorded post-baseline assessment, TTP was censored on the date of randomization; those who remained alive and had randomized but were not treated, TTP was censored at the date of randomization; for those who died without reported disease progression, TTP was censored on the date of death.

Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.

→

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

EORTC QLQ · Change From Baseline in Health-Related Quality of Life (QOL) as Measured by the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Instrument at Week 12

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT00094653
qol key
qol-0012
source section id
NCT00094653-om-0012
source outcome index
12
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Change From Baseline in Health-Related Quality of Life (QOL) as Measured by the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Instrument at Week 12
measure definition
The 30 items were grouped into the following: 1 global QOL scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). All scores were linearly transformed to a 0 to 100 scale. For global QOL and functional items, a higher score represents a better level of functioning (100=best/0=worst). For symptom items, a higher score represents a higher level of symptoms (0=no symptom at all/100=very much severe).
time frame
Baseline (Day 1, Cycle1), Week 12
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher score represents a better
population note
All subjects who received at least 1 dose or any partial dose of study medication. N=number of participants analyzed, n=number of participants with measure at given time points.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT00094653
trial label
MDX-010 Antibody, MDX-1379 Melanoma Vaccine, or MDX-010/MDX-1379 Combination Treatment for Patients With Unresectable or Metastatic Melanoma
applicability
unclear
applicability note
Attached because the study's own record describes metastatic 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
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
3
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-keytruda-qlex-b6745983
    nct id
    NCT00094653
    outcome key
    om-0000
    source section id
    NCT00094653-om-0000
    source outcome index
    0
    endpoint
    Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 in Combination With gp 100 Melanoma Peptide Vaccine Versus gp 100 Melanoma Peptide Vaccine Alone
    endpoint definition
    OS was defined as the time from randomization until death from any cause. If a participant did not expire, the subject was censored at the time of last contact (last known alive date). 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method.
    time origin
    From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-keytruda-qlex-b6745983
    nct id
    NCT00094653
    outcome key
    om-0001
    source section id
    NCT00094653-om-0001
    source outcome index
    1
    endpoint
    Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 Monotherapy Versus gp100 Melanoma Peptide Vaccine Alone and MDX-010 in Combination With gp100 Melanoma Peptide Vaccine Versus MDX-010 Monotherapy
    endpoint definition
    OS was defined as the time from randomization until death from any cause. If a participant did not expire, the subject was censored at the time of last contact (last known alive date). 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method.
    time origin
    From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-keytruda-qlex-b6745983
    nct id
    NCT00094653
    outcome key
    om-0002
    source section id
    NCT00094653-om-0002
    source outcome index
    2
    endpoint
    12-, 18-, and 24-Month Survival Rates
    endpoint definition
    The probability that a subject is alive at 12 months, 18 months, and 24 months following randomization, estimated via the non-parametric method (Kaplan-Meier method). For calculating 95% CI, bootstrap method was used with 20000 simulated trials.
    time origin
    Month 12, Month 18, Month 24
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-keytruda-qlex-b6745983
    nct id
    NCT00094653
    outcome key
    om-0003
    source section id
    NCT00094653-om-0003
    source outcome index
    3
    endpoint
    Progression Free Survival (PFS)
    endpoint definition
    PFS was defined as the number of days between the date of randomization and the date of the progression or the date of death. A subject who died without prior progression was considered to have progressed on the date of death. PFS was determined by investigator. 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method.
    time origin
    From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study. Subjects who neither progressed nor died were censored at the date of the last tumor assessment.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-keytruda-qlex-b6745983
    nct id
    NCT00094653
    outcome key
    om-0004
    source section id
    NCT00094653-om-0004
    source outcome index
    4
    endpoint
    Percentage of Participants With Progression Free Survival (PFS) at Week 12 and Week 24
    endpoint definition
    PFS at Week 12 was defined as the probability that the subject was progression-free at 12 weeks and 24 weeks following the start of randomization. It was computed via Kaplan-Meier method, truncated at Week 12 and Week 24. PFS was determined by investigator. 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method.
    time origin
    Week 12, Week 24
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-keytruda-qlex-b6745983
    nct id
    NCT00094653
    outcome key
    om-0005
    source section id
    NCT00094653-om-0005
    source outcome index
    5
    endpoint
    Time to Progression (TTP)
    endpoint definition
    TTP was defined as the number of days between the date of the randomization and date of PD or death due to PD. For subjects who had not progression and remained alive, TTP was censored on the date of last assessment; those who remained alive and had no recorded post-baseline assessment, TTP was censored on the date of randomization; those who remained alive and had randomized but were not treated, TTP was censored at the date of randomization; for those who died without reported disease progression, TTP was censored on the date of death.
    time origin
    from time of randomization to date of PD or death due to PD (end of the study was defined as the time at which 481 deaths were observed [264 weeks])
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-keytruda-qlex-b6745983
    nct id
    NCT00094653
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Ipilimumab Plus gp100
    regimen
    Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288\[288V\]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217\[210M\]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
    analyzed count
    403
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00094653-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-keytruda-qlex-b6745983
    nct id
    NCT00094653
    outcome key
    om-0000
    arm key
    OG001
    arm label
    gp100
    regimen
    Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288\[288V\]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217\[210M\]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
    analyzed count
    136
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00094653-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-keytruda-qlex-b6745983
    nct id
    NCT00094653
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Ipilimumab Plus gp100
    regimen
    Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288\[288V\]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217\[210M\]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
    analyzed count
    403
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00094653-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-keytruda-qlex-b6745983
    nct id
    NCT00094653
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Ipilimumab Monotherapy
    regimen
    Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
    analyzed count
    137
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00094653-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-keytruda-qlex-b6745983
    nct id
    NCT00094653
    outcome key
    om-0001
    arm key
    OG002
    arm label
    gp100
    regimen
    Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288\[288V\]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217\[210M\]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
    analyzed count
    136
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00094653-om-0001#groups/OG002
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-keytruda-qlex-b6745983
    nct id
    NCT00094653
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Ipilimumab Plus gp100
    regimen
    Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288\[288V\]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217\[210M\]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
    analyzed count
    403
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00094653-om-0002#groups/OG000
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-keytruda-qlex-b6745983
    nct id
    NCT00094653
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Ipilimumab Monotherapy
    regimen
    Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
    analyzed count
    137
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00094653-om-0002#groups/OG001
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-keytruda-qlex-b6745983
    nct id
    NCT00094653
    outcome key
    om-0002
    arm key
    OG002
    arm label
    gp100
    regimen
    Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288\[288V\]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217\[210M\]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
    analyzed count
    136
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00094653-om-0002#groups/OG002
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-keytruda-qlex-b6745983
    nct id
    NCT00094653
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Ipilimumab Plus gp100
    regimen
    Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288\[288V\]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217\[210M\]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
    analyzed count
    403
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00094653-om-0003#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-keytruda-qlex-b6745983
    nct id
    NCT00094653
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Ipilimumab Monotherapy
    regimen
    Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
    analyzed count
    137
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00094653-om-0003#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-keytruda-qlex-b6745983
    nct id
    NCT00094653
    outcome key
    om-0003
    arm key
    OG002
    arm label
    gp100
    regimen
    Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288\[288V\]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217\[210M\]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
    analyzed count
    136
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00094653-om-0003#groups/OG002
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-keytruda-qlex-b6745983
    nct id
    NCT00094653
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Ipilimumab Plus gp100
    regimen
    Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288\[288V\]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217\[210M\]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
    analyzed count
    403
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00094653-om-0004#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-keytruda-qlex-b6745983
    nct id
    NCT00094653
    harm key
    EG000
    source section id
    NCT00094653-ae
    event group key
    EG000
    event group label
    Ipilimumab Monotherapy
    serious affected
    55
    serious at risk
    131
    other affected
    124
    other at risk
    131
    frequency threshold
    5
    collection period
    Source null
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-keytruda-qlex-b6745983
    nct id
    NCT00094653
    harm key
    EG001
    source section id
    NCT00094653-ae
    event group key
    EG001
    event group label
    Ipilimumab Plus gp100
    serious affected
    155
    serious at risk
    380
    other affected
    362
    other at risk
    380
    frequency threshold
    5
    collection period
    Source null
    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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-keytruda-qlex-b6745983
    nct id
    NCT00094653
    harm key
    EG002
    source section id
    NCT00094653-ae
    event group key
    EG002
    event group label
    gp100
    serious affected
    52
    serious at risk
    132
    other affected
    124
    other at risk
    132
    frequency threshold
    5
    collection period
    Source null
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma-keytruda-qlex-b6745983
    nct id
    NCT00094653
    qol key
    qol-0012
    source section id
    NCT00094653-om-0012
    source outcome index
    12
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Change From Baseline in Health-Related Quality of Life (QOL) as Measured by the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Instrument at Week 12
    measure definition
    The 30 items were grouped into the following: 1 global QOL scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). All scores were linearly transformed to a 0 to 100 scale. For global QOL and functional items, a higher score represents a better level of functioning (100=best/0=worst). For symptom items, a higher score represents a higher level of symptoms (0=no symptom at all/100=very much severe).
    time frame
    Baseline (Day 1, Cycle1), Week 12
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    1
    direction quote
    higher score represents a better
    population note
    All subjects who received at least 1 dose or any partial dose of study medication. N=number of participants analyzed, n=number of participants with measure at given time points.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice