← KEYTRUDA QLEX: unresectable metastatic Melanoma

NCT01274338 · STUDY IN CONTEXT

Ipilimumab or High-Dose Interferon Alfa-2b in Treating Patients With High-Risk Stage III-IV Melanoma That Has Been Removed by Surgery

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

Recurrence-free survival is defined as the time from randomization to recurrence or death, whichever occurs first. The following criteria constitute the only acceptable evidence of disease recurrence. Lung and liver: Positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease. Central Nervous System: A positive brain CT or MRI scan or CSF cytology. Cutaneous, Subcutaneous and Lymph Node Recurrence: Positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease. Bone and Other Organs: Positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease identified on two different radiologic studies: i.e., positive nuclear bone scan or PET scan and contrast GI series or ultrasound, X-ray or CT of abdomen for abdominal disease.

Concurrently randomized patients on Arms B and C

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primary · POSTED

Overall survival is defined as the time from randomization to death or date last known alive.

Concurrently randomized patients on Arms B and C

→

primary · POSTED

Recurrence-free survival is defined as the time from randomization to recurrence or death, whichever occurs first. The following criteria constitute the only acceptable evidence of disease recurrence. Lung and liver: Positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease. Central Nervous System: A positive brain CT or MRI scan or CSF cytology. Cutaneous, Subcutaneous and Lymph Node Recurrence: Positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease. Bone and Other Organs: Positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease identified on two different radiologic studies: i.e., positive nuclear bone scan or PET scan and contrast GI series or ultrasound, X-ray or CT of abdomen for abdominal disease.

Concurrently randomized patients on Arms A and B

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primary · POSTED

Overall survival is defined as the time from randomization to death or date last known alive.

Concurrently randomized patients on Arms A and B

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secondary · POSTED

The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire that has four areas of measurements (physical well-being, social/family well-being, emotional well-being and functional well-being) with a scale of 0-4. The FACT-G total score ranges between 0 and 108. The higher the score, the better the quality of life. Change in FACT-G total score from baseline to 3 months was calculated as month 3 score - baseline score.

Patients with baseline and 3-month FACT-G assessments were included in this analysis. Pediatric patients did not participate in the quality of life part of the study.

→

secondary · POSTED

The diarrhea subscale of The Functional Assessment of Chronic Illness Therapy - Diarrhea (FACIT-D) is an 11-item questionnaire with a scale of 0-4. The FACIT-D diarrhea subscale score ranges between 0 and 44. The higher the score, the better the quality of life. Change in FACIT-D diarrhea subscale score from baseline to 3 months was calculated as month 3 score - baseline score.

Patients with baseline and 3-month FACIT-D diarrhea subscale assessments were included in this analysis. Pediatric patients did not participate in the quality of life part of 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

FACT · Change in FACT-G (Functional Assessment of Cancer Therapy - General) Total Score From Baseline to 3 Months

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: NCT01274338
qol key: qol-0004
source section id: NCT01274338-om-0004
source outcome index: 4
instrument: FACT
instrument basis: matched 'fact-g' in the study's own wording
scale title: Change in FACT-G (Functional Assessment of Cancer Therapy - General) Total Score From Baseline to 3 Months
measure definition: The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire that has four areas of measurements (physical well-being, social/family well-being, emotional well-being and functional well-being) with a scale of 0-4. The FACT-G total score ranges between 0 and 108. The higher the score, the better the quality of life. Change in FACT-G total score from baseline to 3 months was calculated as month 3 score - baseline score.
time frame: Assessed at baseline and 3 months
analysis role: secondary
reporting status: POSTED
higher is better: 1
direction quote: higher the score, the better
population note: Patients with baseline and 3-month FACT-G assessments were included in this analysis. Pediatric patients did not participate in the quality of life part of the study.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

Unnamed quality-of-life measure · Change in FACIT-D (Functional Assessment of Cancer Therapy - Diarrhea) Diarrhea Subscale Score From Baseline to 3 Months

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: NCT01274338
qol key: qol-0005
source section id: NCT01274338-om-0005
source outcome index: 5
instrument: Unnamed quality-of-life measure
instrument basis: matched 'quality of life' in the study's own wording
scale title: Change in FACIT-D (Functional Assessment of Cancer Therapy - Diarrhea) Diarrhea Subscale Score From Baseline to 3 Months
measure definition: The diarrhea subscale of The Functional Assessment of Chronic Illness Therapy - Diarrhea (FACIT-D) is an 11-item questionnaire with a scale of 0-4. The FACIT-D diarrhea subscale score ranges between 0 and 44. The higher the score, the better the quality of life. Change in FACIT-D diarrhea subscale score from baseline to 3 months was calculated as month 3 score - baseline score.
time frame: Assessed at baseline and 3 months
analysis role: secondary
reporting status: POSTED
higher is better: 1
direction quote: higher the score, the better
population note: Patients with baseline and 3-month FACIT-D diarrhea subscale assessments were included in this analysis. Pediatric patients did not participate in the quality of life part of the study.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

FACT · Change in FACT-BRM (Functional Assessment of Cancer Therapy - Biologic Response Modifiers) Total Score From Baseline to 3 Months

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: NCT01274338
qol key: qol-0006
source section id: NCT01274338-om-0006
source outcome index: 6
instrument: FACT
instrument basis: matched 'fact-brm' in the study's own wording
scale title: Change in FACT-BRM (Functional Assessment of Cancer Therapy - Biologic Response Modifiers) Total Score From Baseline to 3 Months
measure definition: The Functional Assessment of Cancer Therapy - Biologic Response Modifiers (FACT-BRM) is a questionnaire including FACT-G (The Functional Assessment of Cancer Therapy - General) and additional sections addressing physical and mental quality of life aspects. It is a 40-item questionnaire with a scale of 0-4. The FACT-BRM total score ranges between 0 and 160. The higher the score, the better the quality of life. Change in FACT-BRM total score from baseline to 3 months is calculated as month 3 score - baseline score.
time frame: Assessed at baseline and 3 months
analysis role: secondary
reporting status: POSTED
higher is better: 1
direction quote: higher the score, the better
population note: Patients with baseline and 3-month FACT-BRM assessments were included in this analysis. Pediatric patients did not participate in the quality of life part of the study.
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: NCT01274338
trial label: Ipilimumab or High-Dose Interferon Alfa-2b in Treating Patients With High-Risk Stage III-IV Melanoma That Has Been Removed by Surgery
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: 6
qol Count: 3

outcomes

release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01274338
outcome key
om-0000
source section id
NCT01274338-om-0000
source outcome index
0
endpoint
Recurrence-free Survival (RFS; Arm B [HDI] vs. Arm C [LIP])
endpoint definition
Recurrence-free survival is defined as the time from randomization to recurrence or death, whichever occurs first. The following criteria constitute the only acceptable evidence of disease recurrence. Lung and liver: Positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease. Central Nervous System: A positive brain CT or MRI scan or CSF cytology. Cutaneous, Subcutaneous and Lymph Node Recurrence: Positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease. Bone and Other Organs: Positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease identified on two different radiologic studies: i.e., positive nuclear bone scan or PET scan and contrast GI series or ultrasound, X-ray or CT of abdomen for abdominal disease.
time origin
Assessed every 3 months for 2 years, then every 6 months for years 3-5 and then annually up to 8 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Concurrently randomized patients on Arms B and C
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-melanoma-keytruda-qlex-b6745983
nct id
NCT01274338
outcome key
om-0001
source section id
NCT01274338-om-0001
source outcome index
1
endpoint
5-year Overall Survival (OS) Rate (Arm B [HDI] vs. Arm C [LIP])
endpoint definition
Overall survival is defined as the time from randomization to death or date last known alive.
time origin
Assessed every 3 months for 2 years, then every 6 months for years 3-5
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Concurrently randomized patients on Arms B and C
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-melanoma-keytruda-qlex-b6745983
nct id
NCT01274338
outcome key
om-0002
source section id
NCT01274338-om-0002
source outcome index
2
endpoint
Recurrence-free Survival (RFS; Arm A [HIP] vs. Arm B [HDI])
endpoint definition
Recurrence-free survival is defined as the time from randomization to recurrence or death, whichever occurs first. The following criteria constitute the only acceptable evidence of disease recurrence. Lung and liver: Positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease. Central Nervous System: A positive brain CT or MRI scan or CSF cytology. Cutaneous, Subcutaneous and Lymph Node Recurrence: Positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease. Bone and Other Organs: Positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease identified on two different radiologic studies: i.e., positive nuclear bone scan or PET scan and contrast GI series or ultrasound, X-ray or CT of abdomen for abdominal disease.
time origin
Assessed every 3 months for 2 years, then every 6 months for years 3-5 and then annually up to 8 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Concurrently randomized patients on Arms A and B
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-melanoma-keytruda-qlex-b6745983
nct id
NCT01274338
outcome key
om-0003
source section id
NCT01274338-om-0003
source outcome index
3
endpoint
5-year Overall Survival (OS) Rate (Arm A [HIP] vs. Arm B [HDI])
endpoint definition
Overall survival is defined as the time from randomization to death or date last known alive.
time origin
Assessed every 3 months for 2 years, then every 6 months for years 3-5
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Concurrently randomized patients on Arms A and B
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-melanoma-keytruda-qlex-b6745983
nct id
NCT01274338
outcome key
om-0004
source section id
NCT01274338-om-0004
source outcome index
4
endpoint
Change in FACT-G (Functional Assessment of Cancer Therapy - General) Total Score From Baseline to 3 Months
endpoint definition
The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire that has four areas of measurements (physical well-being, social/family well-being, emotional well-being and functional well-being) with a scale of 0-4. The FACT-G total score ranges between 0 and 108. The higher the score, the better the quality of life. Change in FACT-G total score from baseline to 3 months was calculated as month 3 score - baseline score.
time origin
Assessed at baseline and 3 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Patients with baseline and 3-month FACT-G assessments were included in this analysis. Pediatric patients did not participate in the quality of life part of the study.
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-melanoma-keytruda-qlex-b6745983
nct id
NCT01274338
outcome key
om-0005
source section id
NCT01274338-om-0005
source outcome index
5
endpoint
Change in FACIT-D (Functional Assessment of Cancer Therapy - Diarrhea) Diarrhea Subscale Score From Baseline to 3 Months
endpoint definition
The diarrhea subscale of The Functional Assessment of Chronic Illness Therapy - Diarrhea (FACIT-D) is an 11-item questionnaire with a scale of 0-4. The FACIT-D diarrhea subscale score ranges between 0 and 44. The higher the score, the better the quality of life. Change in FACIT-D diarrhea subscale score from baseline to 3 months was calculated as month 3 score - baseline score.
time origin
Assessed at baseline and 3 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Patients with baseline and 3-month FACIT-D diarrhea subscale assessments were included in this analysis. Pediatric patients did not participate in the quality of life part of the study.
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-melanoma-keytruda-qlex-b6745983
nct id
NCT01274338
outcome key
om-0000
arm key
OG000
arm label
Arm B (HDI)
regimen
Patients receive high-dose recombinant interferon alpha-2b IV on days 1-5, 8-12, 15-19, and 22-26 in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance high-dose recombinant interferon alpha-2b SC on days 1, 3, and 5. Treatment repeats every week for 48 weeks in the absence of disease progression or unacceptable toxicity.
analyzed count
528
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01274338-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01274338
outcome key
om-0000
arm key
OG001
arm label
Arm C (LIP)
regimen
Patients receive induction low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 12 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.
analyzed count
523
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01274338-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01274338
outcome key
om-0001
arm key
OG000
arm label
Arm B (HDI)
regimen
Patients receive high-dose recombinant interferon alpha-2b IV on days 1-5, 8-12, 15-19, and 22-26 in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance high-dose recombinant interferon alpha-2b SC on days 1, 3, and 5. Treatment repeats every week for 48 weeks in the absence of disease progression or unacceptable toxicity.
analyzed count
528
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01274338-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01274338
outcome key
om-0001
arm key
OG001
arm label
Arm C (LIP)
regimen
Patients receive induction low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 12 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.
analyzed count
523
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01274338-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01274338
outcome key
om-0002
arm key
OG000
arm label
Arm A (HIP)
regimen
Patients receive induction high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 12 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.
analyzed count
511
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01274338-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01274338
outcome key
om-0002
arm key
OG001
arm label
Arm B (HDI)
regimen
Patients receive high-dose recombinant interferon alpha-2b IV on days 1-5, 8-12, 15-19, and 22-26 in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance high-dose recombinant interferon alpha-2b SC on days 1, 3, and 5. Treatment repeats every week for 48 weeks in the absence of disease progression or unacceptable toxicity.
analyzed count
478
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01274338-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01274338
outcome key
om-0003
arm key
OG000
arm label
Arm A (HIP)
regimen
Patients receive induction high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 12 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.
analyzed count
511
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01274338-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01274338
outcome key
om-0003
arm key
OG001
arm label
Arm B (HDI)
regimen
Patients receive high-dose recombinant interferon alpha-2b IV on days 1-5, 8-12, 15-19, and 22-26 in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance high-dose recombinant interferon alpha-2b SC on days 1, 3, and 5. Treatment repeats every week for 48 weeks in the absence of disease progression or unacceptable toxicity.
analyzed count
478
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01274338-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01274338
outcome key
om-0004
arm key
OG000
arm label
Arm A (HIP)
regimen
Patients receive induction high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 12 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.
analyzed count
110
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01274338-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01274338
outcome key
om-0004
arm key
OG001
arm label
Arm B (HDI)
regimen
Patients receive high-dose recombinant interferon alpha-2b IV on days 1-5, 8-12, 15-19, and 22-26 in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance high-dose recombinant interferon alpha-2b SC on days 1, 3, and 5. Treatment repeats every week for 48 weeks in the absence of disease progression or unacceptable toxicity.
analyzed count
114
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01274338-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01274338
outcome key
om-0004
arm key
OG002
arm label
Arm C (LIP)
regimen
Patients receive induction low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 12 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.
analyzed count
97
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01274338-om-0004#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01274338
outcome key
om-0005
arm key
OG000
arm label
Arm A (HIP)
regimen
Patients receive induction high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 12 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.
analyzed count
109
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01274338-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01274338
harm key
EG000
source section id
NCT01274338-ae
event group key
EG000
event group label
Arm A (HIP)
serious affected
292
serious at risk
503
other affected
495
other at risk
503
frequency threshold
5
collection period
Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 20 years
event definition
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
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-melanoma-keytruda-qlex-b6745983
nct id
NCT01274338
harm key
EG001
source section id
NCT01274338-ae
event group key
EG001
event group label
Arm B (HDI)
serious affected
410
serious at risk
520
other affected
510
other at risk
520
frequency threshold
5
collection period
Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 20 years
event definition
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
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-melanoma-keytruda-qlex-b6745983
nct id
NCT01274338
harm key
EG002
source section id
NCT01274338-ae
event group key
EG002
event group label
Arm C (LIP)
serious affected
197
serious at risk
516
other affected
488
other at risk
516
frequency threshold
5
collection period
Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 20 years
event definition
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
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-melanoma-keytruda-qlex-b6745983
nct id
NCT01274338
harm key
EG003
source section id
NCT01274338-ae
event group key
EG003
event group label
Arm D (HIP; Pediatric)
serious affected
0
serious at risk
1
other affected
0
other at risk
1
frequency threshold
5
collection period
Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 20 years
event definition
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
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-melanoma-keytruda-qlex-b6745983
nct id
NCT01274338
harm key
EG004
source section id
NCT01274338-ae
event group key
EG004
event group label
Arm E (HDI; Pediatric)
serious affected
0
serious at risk
1
other affected
0
other at risk
1
frequency threshold
5
collection period
Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 20 years
event definition
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
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-melanoma-keytruda-qlex-b6745983
nct id
NCT01274338
harm key
EG005
source section id
NCT01274338-ae
event group key
EG005
event group label
Arm F (LIP; Pediatric)
serious affected
0
serious at risk
1
other affected
0
other at risk
1
frequency threshold
5
collection period
Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 20 years
event definition
Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
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

release id
clinical-indications-draft-1
disease state id
ds-melanoma-keytruda-qlex-b6745983
nct id
NCT01274338
qol key
qol-0004
source section id
NCT01274338-om-0004
source outcome index
4
instrument
FACT
instrument basis
matched 'fact-g' in the study's own wording
scale title
Change in FACT-G (Functional Assessment of Cancer Therapy - General) Total Score From Baseline to 3 Months
measure definition
The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire that has four areas of measurements (physical well-being, social/family well-being, emotional well-being and functional well-being) with a scale of 0-4. The FACT-G total score ranges between 0 and 108. The higher the score, the better the quality of life. Change in FACT-G total score from baseline to 3 months was calculated as month 3 score - baseline score.
time frame
Assessed at baseline and 3 months
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher the score, the better
population note
Patients with baseline and 3-month FACT-G assessments were included in this analysis. Pediatric patients did not participate in the quality of life part of the study.
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-melanoma-keytruda-qlex-b6745983
nct id
NCT01274338
qol key
qol-0005
source section id
NCT01274338-om-0005
source outcome index
5
instrument
Unnamed quality-of-life measure
instrument basis
matched 'quality of life' in the study's own wording
scale title
Change in FACIT-D (Functional Assessment of Cancer Therapy - Diarrhea) Diarrhea Subscale Score From Baseline to 3 Months
measure definition
The diarrhea subscale of The Functional Assessment of Chronic Illness Therapy - Diarrhea (FACIT-D) is an 11-item questionnaire with a scale of 0-4. The FACIT-D diarrhea subscale score ranges between 0 and 44. The higher the score, the better the quality of life. Change in FACIT-D diarrhea subscale score from baseline to 3 months was calculated as month 3 score - baseline score.
time frame
Assessed at baseline and 3 months
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher the score, the better
population note
Patients with baseline and 3-month FACIT-D diarrhea subscale assessments were included in this analysis. Pediatric patients did not participate in the quality of life part of the study.
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-melanoma-keytruda-qlex-b6745983
nct id
NCT01274338
qol key
qol-0006
source section id
NCT01274338-om-0006
source outcome index
6
instrument
FACT
instrument basis
matched 'fact-brm' in the study's own wording
scale title
Change in FACT-BRM (Functional Assessment of Cancer Therapy - Biologic Response Modifiers) Total Score From Baseline to 3 Months
measure definition
The Functional Assessment of Cancer Therapy - Biologic Response Modifiers (FACT-BRM) is a questionnaire including FACT-G (The Functional Assessment of Cancer Therapy - General) and additional sections addressing physical and mental quality of life aspects. It is a 40-item questionnaire with a scale of 0-4. The FACT-BRM total score ranges between 0 and 160. The higher the score, the better the quality of life. Change in FACT-BRM total score from baseline to 3 months is calculated as month 3 score - baseline score.
time frame
Assessed at baseline and 3 months
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher the score, the better
population note
Patients with baseline and 3-month FACT-BRM assessments were included in this analysis. Pediatric patients did not participate in the quality of life part of the study.
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