NCT02371369 · STUDY IN CONTEXT

Phase 3 Study of Pexidartinib for Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCT-TS)

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. 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

Complete response (CR) and partial responses (PR) were assessed based on centrally-read magnetic resonance imaging (MRI) scans and Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1). A CR was defined as disappearance of all tumors and a PR was defined as at least a 30% decrease in the sum of diameters of target tumors using the baseline sum diameters as the reference.

Best overall response was assessed in the Intent-to-Treat (ITT) population.

→

secondary · POSTED

Range of motion (ROM) of the joint was assessed by a qualified, independent, and blinded or third-party assessors at the clinical site. Measurements were recorded in degrees. At baseline, the plane of movement with the smallest relative value (worst) was identified and this plane was used for evaluating the relative change of motion subsequently. Only the plane with the worst impaired ROM at baseline was selected for subsequent analyses.

Range of motion was assessed in the ITT population in participants where data were available.

→

secondary · POSTED

Complete response (CR) and partial response (PR) were assessed using tumor volume score (TVS). A CR was defined as disappearance of all tumors and a PR was defined as at least a 30% decrease in the sum of diameters of target tumors using the baseline sum diameters as the reference. TVS is a semi-quantitative MRI scoring system that describes tumor mass and is based on 10% increments of the estimated volume of the maximally distended synovial cavity or tendon sheath involved. A tumor that is equal in volume to that of a maximally distended synovial cavity or tendon sheath was scored 10; a score of 0 indicated no evidence of tumor.

Best overall response was assessed in the ITT population.

→

secondary · POSTED

The Patient-reported Outcomes Measurement Information System (PROMIS) physical function scale was used to assess physical function of the upper and lower limbs. The scale ranged from 1 defined as 'unable to do' or 'cannot do' to 5 defined as 'without any difficulty' or 'not at all', where higher scores represent better outcomes.

Physical function was assessed in the ITT population in participants where data were available.

→

secondary · POSTED

The Worst Stiffness Numeric Rating Scale (NRS) was a 1-item, self-administered questionnaire assessing the "worst" stiffness in the last 24 hours. The NRS for this item ranged from 0 (no stiffness) to 10 (stiffness as bad as you can imagine).

Worst stiffness was assessed in the ITT population.

→

secondary · POSTED

The Brief Pain Inventory (BPI) Worst Pain Numeric Rating Scale Score (NRS) was a 1-item, self-administered questionnaire assessing the "worst" pain in the last 24 hours. The NRS for this item ranged from 0 (no pain) to 10 (pain as bad as you can imagine).

Worst pain was assessed in the ITT population.

→

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

PROMIS · Mean Change From Baseline in the Patient-reported Outcomes Measurement Information System (PROMIS) Physical Function Score in Participants Receiving Pexidartinib Compared With Those on Placebo Up to Week 25

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-tenosynovial-giant-cell-tumor
nct id: NCT02371369
qol key: qol-0003
source section id: NCT02371369-om-0003
source outcome index: 3
instrument: PROMIS
instrument basis: matched 'promis' in the study's own wording
scale title: Mean Change From Baseline in the Patient-reported Outcomes Measurement Information System (PROMIS) Physical Function Score in Participants Receiving Pexidartinib Compared With Those on Placebo Up to Week 25
measure definition: The Patient-reported Outcomes Measurement Information System (PROMIS) physical function scale was used to assess physical function of the upper and lower limbs. The scale ranged from 1 defined as 'unable to do' or 'cannot do' to 5 defined as 'without any difficulty' or 'not at all', where higher scores represent better outcomes.
time frame: at Week 9 , Week 17, and Week 25
analysis role: secondary
reporting status: POSTED
higher is better: 1
direction quote: higher scores represent better
population note: Physical function was assessed in the ITT population in participants where data were available.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

Brief Pain Inventory · Percentage of Participants Who Responded With a Decrease of at Least 30% in the Mean Brief Pain Inventory Worst Pain Numeric Rating Scale Score Among Participants Receiving Pexidartinib Compared With Those on Placebo at Week 25

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-tenosynovial-giant-cell-tumor
nct id: NCT02371369
qol key: qol-0005
source section id: NCT02371369-om-0005
source outcome index: 5
instrument: Brief Pain Inventory
instrument basis: matched 'brief pain inventory' in the study's own wording
scale title: Percentage of Participants Who Responded With a Decrease of at Least 30% in the Mean Brief Pain Inventory Worst Pain Numeric Rating Scale Score Among Participants Receiving Pexidartinib Compared With Those on Placebo at Week 25
measure definition: The Brief Pain Inventory (BPI) Worst Pain Numeric Rating Scale Score (NRS) was a 1-item, self-administered questionnaire assessing the "worst" pain in the last 24 hours. The NRS for this item ranged from 0 (no pain) to 10 (pain as bad as you can imagine).
time frame: Week 25
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: Worst pain was assessed in the ITT population.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

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-tenosynovial-giant-cell-tumor
nct id: NCT02371369
qol key: qol-0013
source section id: NCT02371369-om-0013
source outcome index: 13
instrument: PROMIS
instrument basis: matched 'promis' in the study's own wording
scale title: Mean Change From Baseline in the Patient-reported Outcomes Measurement Information System (PROMIS) Physical Function Score in Participants Receiving Pexidartinib Compared With Those on Placebo by Week 49
measure definition: The Patient-reported Outcomes Measurement Information System (PROMIS) physical function scale was used to assess physical function of the upper and lower limbs. The scale ranged from 1 defined as 'unable to do' or 'cannot do' to 5 defined as 'without any difficulty' or 'not at all', where higher scores represent better outcomes.
time frame: By Week 49
analysis role: exploratory
reporting status: POSTED
higher is better: 1
direction quote: higher scores represent better
population note: Physical function was assessed in the ITT population.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

Brief Pain Inventory · Mean Change From Baseline for Worst Pain Numeric Rating Scale Score (NRS) in Participants Receiving Pexidartinib Compared With Those on Placebo by Week 49

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-tenosynovial-giant-cell-tumor
nct id: NCT02371369
qol key: qol-0015
source section id: NCT02371369-om-0015
source outcome index: 15
instrument: Brief Pain Inventory
instrument basis: matched 'brief pain inventory' in the study's own wording
scale title: Mean Change From Baseline for Worst Pain Numeric Rating Scale Score (NRS) in Participants Receiving Pexidartinib Compared With Those on Placebo by Week 49
measure definition: The Brief Pain Inventory (BPI) Worst Pain NRS was a 1-item, self-administered questionnaire assessing the "worst" pain in the last 24 hours. The NRS for this item ranged from 0 (no pain) to 10 (pain as bad as you can imagine).
time frame: By Week 49
analysis role: exploratory
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: Worst pain was assessed in the ITT population, specifically among the Pexidartinib Part 1, Pexidartinib Part 2; Placebo Part 1, Pexidartinib Part 2; and All Pexidartinib Treated participants. Participants who received Placebo Part 1 only or Pexidartinib Part 2 only were not analyzed.
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-tenosynovial-giant-cell-tumor
nct id: NCT02371369
trial label: Phase 3 Study of Pexidartinib for Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCT-TS)
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.
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: 5
qol Count: 4

outcomes

release id
clinical-indications-draft-1
disease state id
ds-tenosynovial-giant-cell-tumor
nct id
NCT02371369
outcome key
om-0000
source section id
NCT02371369-om-0000
source outcome index
0
endpoint
Percentage of Participants With Symptomatic, Locally Advanced Tenosynovial Giant Cell Tumor (TGCT) Achieving Complete or Partial Response to Pexidartinib Compared With That of Placebo Per Response Evaluation Criteria in Solid Tumors Version 1.1 at Week 25
endpoint definition
Complete response (CR) and partial responses (PR) were assessed based on centrally-read magnetic resonance imaging (MRI) scans and Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1). A CR was defined as disappearance of all tumors and a PR was defined as at least a 30% decrease in the sum of diameters of target tumors using the baseline sum diameters as the reference.
time origin
Week 25
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Best overall response was assessed in the Intent-to-Treat (ITT) population.
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-tenosynovial-giant-cell-tumor
nct id
NCT02371369
outcome key
om-0001
source section id
NCT02371369-om-0001
source outcome index
1
endpoint
Mean Change From Baseline For Range of Motion (ROM) Score in Participants Receiving Pexidartinib Compared With Those on Placebo Up to Week 25
endpoint definition
Range of motion (ROM) of the joint was assessed by a qualified, independent, and blinded or third-party assessors at the clinical site. Measurements were recorded in degrees. At baseline, the plane of movement with the smallest relative value (worst) was identified and this plane was used for evaluating the relative change of motion subsequently. Only the plane with the worst impaired ROM at baseline was selected for subsequent analyses.
time origin
Baseline, Week 13, and Week 25
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Range of motion was assessed in the ITT population in participants where data were available.
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-tenosynovial-giant-cell-tumor
nct id
NCT02371369
outcome key
om-0002
source section id
NCT02371369-om-0002
source outcome index
2
endpoint
Percentage of Participants With Symptomatic, Locally Advanced Tenosynovial Giant Cell Tumor (TGCT) Achieving Complete or Partial Response Based on Tumor Volume Score (TVS) After Receiving Pexidartinib Compared With Those on Placebo at Week 25
endpoint definition
Complete response (CR) and partial response (PR) were assessed using tumor volume score (TVS). A CR was defined as disappearance of all tumors and a PR was defined as at least a 30% decrease in the sum of diameters of target tumors using the baseline sum diameters as the reference. TVS is a semi-quantitative MRI scoring system that describes tumor mass and is based on 10% increments of the estimated volume of the maximally distended synovial cavity or tendon sheath involved. A tumor that is equal in volume to that of a maximally distended synovial cavity or tendon sheath was scored 10; a score of 0 indicated no evidence of tumor.
time origin
Week 25
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Best overall response was assessed in the ITT population.
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-tenosynovial-giant-cell-tumor
nct id
NCT02371369
outcome key
om-0003
source section id
NCT02371369-om-0003
source outcome index
3
endpoint
Mean Change From Baseline in the Patient-reported Outcomes Measurement Information System (PROMIS) Physical Function Score in Participants Receiving Pexidartinib Compared With Those on Placebo Up to Week 25
endpoint definition
The Patient-reported Outcomes Measurement Information System (PROMIS) physical function scale was used to assess physical function of the upper and lower limbs. The scale ranged from 1 defined as 'unable to do' or 'cannot do' to 5 defined as 'without any difficulty' or 'not at all', where higher scores represent better outcomes.
time origin
at Week 9 , Week 17, and Week 25
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Physical function was assessed in the ITT population in participants where data were available.
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-tenosynovial-giant-cell-tumor
nct id
NCT02371369
outcome key
om-0004
source section id
NCT02371369-om-0004
source outcome index
4
endpoint
Mean Change From Baseline for Worst Stiffness Numeric Rating Scale Score (NRS) in Participants Receiving Pexidartinib Compared With Those on Placebo Up to Week 25
endpoint definition
The Worst Stiffness Numeric Rating Scale (NRS) was a 1-item, self-administered questionnaire assessing the "worst" stiffness in the last 24 hours. The NRS for this item ranged from 0 (no stiffness) to 10 (stiffness as bad as you can imagine).
time origin
Baseline, Week 9, Week 17, and Week 25
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Worst stiffness was assessed in the ITT population.
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-tenosynovial-giant-cell-tumor
nct id
NCT02371369
outcome key
om-0005
source section id
NCT02371369-om-0005
source outcome index
5
endpoint
Percentage of Participants Who Responded With a Decrease of at Least 30% in the Mean Brief Pain Inventory Worst Pain Numeric Rating Scale Score Among Participants Receiving Pexidartinib Compared With Those on Placebo at Week 25
endpoint definition
The Brief Pain Inventory (BPI) Worst Pain Numeric Rating Scale Score (NRS) was a 1-item, self-administered questionnaire assessing the "worst" pain in the last 24 hours. The NRS for this item ranged from 0 (no pain) to 10 (pain as bad as you can imagine).
time origin
Week 25
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Worst pain was assessed in the ITT population.
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-tenosynovial-giant-cell-tumor
nct id
NCT02371369
outcome key
om-0000
arm key
OG000
arm label
Pexidartinib Part 1
regimen
Participants received treatment of Pexidartinib,1000 mg (5 capsules per day ) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks Pexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration.
analyzed count
61
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02371369-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-tenosynovial-giant-cell-tumor
nct id
NCT02371369
outcome key
om-0000
arm key
OG001
arm label
Placebo Part 1
regimen
Participants received treatment of matching placebo (5 capsules per day) for 2 weeks, then matching placebo (4 capsules per day) for 22 weeks Placebo: Placebo capsule matching Pexidartinib capsule for oral administration.
analyzed count
59
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02371369-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-tenosynovial-giant-cell-tumor
nct id
NCT02371369
outcome key
om-0001
arm key
OG000
arm label
Pexidartinib Part 1
regimen
Participants received treatment of Pexidartinib,1000 mg (5 capsules per day ) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks Pexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration.
analyzed count
61
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02371369-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-tenosynovial-giant-cell-tumor
nct id
NCT02371369
outcome key
om-0001
arm key
OG001
arm label
Placebo Part 1
regimen
Participants received treatment of matching placebo (5 capsules per day) for 2 weeks, then matching placebo (4 capsules per day) for 22 weeks Placebo: Placebo capsule matching Pexidartinib capsule for oral administration.
analyzed count
59
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02371369-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-tenosynovial-giant-cell-tumor
nct id
NCT02371369
outcome key
om-0002
arm key
OG000
arm label
Pexidartinib Part 1
regimen
Participants received treatment of Pexidartinib,1000 mg (5 capsules per day ) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks Pexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration.
analyzed count
61
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02371369-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-tenosynovial-giant-cell-tumor
nct id
NCT02371369
outcome key
om-0002
arm key
OG001
arm label
Placebo Part 1
regimen
Participants received treatment of matching placebo (5 capsules per day) for 2 weeks, then matching placebo (4 capsules per day) for 22 weeks Placebo: Placebo capsule matching Pexidartinib capsule for oral administration.
analyzed count
59
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02371369-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-tenosynovial-giant-cell-tumor
nct id
NCT02371369
outcome key
om-0003
arm key
OG000
arm label
Pexidartinib Part 1
regimen
Participants received treatment of Pexidartinib,1000 mg (5 capsules per day ) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks Pexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration.
analyzed count
61
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02371369-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-tenosynovial-giant-cell-tumor
nct id
NCT02371369
outcome key
om-0003
arm key
OG001
arm label
Placebo Part 1
regimen
Participants received treatment of matching placebo (5 capsules per day) for 2 weeks, then matching placebo (4 capsules per day) for 22 weeks Placebo: Placebo capsule matching Pexidartinib capsule for oral administration.
analyzed count
59
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02371369-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-tenosynovial-giant-cell-tumor
nct id
NCT02371369
outcome key
om-0004
arm key
OG000
arm label
Pexidartinib Part 1
regimen
Participants received treatment of Pexidartinib,1000 mg (5 capsules per day ) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks Pexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration.
analyzed count
61
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02371369-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-tenosynovial-giant-cell-tumor
nct id
NCT02371369
outcome key
om-0004
arm key
OG001
arm label
Placebo Part 1
regimen
Participants received treatment of matching placebo (5 capsules per day) for 2 weeks, then matching placebo (4 capsules per day) for 22 weeks Placebo: Placebo capsule matching Pexidartinib capsule for oral administration.
analyzed count
59
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02371369-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-tenosynovial-giant-cell-tumor
nct id
NCT02371369
outcome key
om-0005
arm key
OG000
arm label
Pexidartinib Part 1
regimen
Participants received treatment of Pexidartinib,1000 mg (5 capsules per day ) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks Pexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration.
analyzed count
61
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02371369-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-tenosynovial-giant-cell-tumor
nct id
NCT02371369
outcome key
om-0005
arm key
OG001
arm label
Placebo Part 1
regimen
Participants received treatment of matching placebo (5 capsules per day) for 2 weeks, then matching placebo (4 capsules per day) for 22 weeks Placebo: Placebo capsule matching Pexidartinib capsule for oral administration.
analyzed count
59
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02371369-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-tenosynovial-giant-cell-tumor
nct id
NCT02371369
harm key
EG000
source section id
NCT02371369-ae
event group key
EG000
event group label
Pexidartinib (Part 1)
serious affected
8
serious at risk
61
other affected
60
other at risk
61
frequency threshold
5
collection period
Adverse events were monitored throughout the study from the time the participant signed the informed consent form to 28 days after the final treatment dose, up to 71 months.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-tenosynovial-giant-cell-tumor
nct id
NCT02371369
harm key
EG001
source section id
NCT02371369-ae
event group key
EG001
event group label
Placebo (Part 1)
serious affected
1
serious at risk
59
other affected
55
other at risk
59
frequency threshold
5
collection period
Adverse events were monitored throughout the study from the time the participant signed the informed consent form to 28 days after the final treatment dose, up to 71 months.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-tenosynovial-giant-cell-tumor
nct id
NCT02371369
harm key
EG002
source section id
NCT02371369-ae
event group key
EG002
event group label
Pexidartinib (Parts 1 and 2)
serious affected
12
serious at risk
61
other affected
61
other at risk
61
frequency threshold
5
collection period
Adverse events were monitored throughout the study from the time the participant signed the informed consent form to 28 days after the final treatment dose, up to 71 months.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-tenosynovial-giant-cell-tumor
nct id
NCT02371369
harm key
EG003
source section id
NCT02371369-ae
event group key
EG003
event group label
Placebo (Part 1), Crossover Pexidartinib (Part 2)
serious affected
9
serious at risk
30
other affected
30
other at risk
30
frequency threshold
5
collection period
Adverse events were monitored throughout the study from the time the participant signed the informed consent form to 28 days after the final treatment dose, up to 71 months.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-tenosynovial-giant-cell-tumor
nct id
NCT02371369
harm key
EG004
source section id
NCT02371369-ae
event group key
EG004
event group label
All Pexidartinib Treated
serious affected
21
serious at risk
91
other affected
91
other at risk
91
frequency threshold
5
collection period
Adverse events were monitored throughout the study from the time the participant signed the informed consent form to 28 days after the final treatment dose, up to 71 months.
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

release id
clinical-indications-draft-1
disease state id
ds-tenosynovial-giant-cell-tumor
nct id
NCT02371369
qol key
qol-0003
source section id
NCT02371369-om-0003
source outcome index
3
instrument
PROMIS
instrument basis
matched 'promis' in the study's own wording
scale title
Mean Change From Baseline in the Patient-reported Outcomes Measurement Information System (PROMIS) Physical Function Score in Participants Receiving Pexidartinib Compared With Those on Placebo Up to Week 25
measure definition
The Patient-reported Outcomes Measurement Information System (PROMIS) physical function scale was used to assess physical function of the upper and lower limbs. The scale ranged from 1 defined as 'unable to do' or 'cannot do' to 5 defined as 'without any difficulty' or 'not at all', where higher scores represent better outcomes.
time frame
at Week 9 , Week 17, and Week 25
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher scores represent better
population note
Physical function was assessed in the ITT population in participants where data were available.
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-tenosynovial-giant-cell-tumor
nct id
NCT02371369
qol key
qol-0005
source section id
NCT02371369-om-0005
source outcome index
5
instrument
Brief Pain Inventory
instrument basis
matched 'brief pain inventory' in the study's own wording
scale title
Percentage of Participants Who Responded With a Decrease of at Least 30% in the Mean Brief Pain Inventory Worst Pain Numeric Rating Scale Score Among Participants Receiving Pexidartinib Compared With Those on Placebo at Week 25
measure definition
The Brief Pain Inventory (BPI) Worst Pain Numeric Rating Scale Score (NRS) was a 1-item, self-administered questionnaire assessing the "worst" pain in the last 24 hours. The NRS for this item ranged from 0 (no pain) to 10 (pain as bad as you can imagine).
time frame
Week 25
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Worst pain was assessed in the ITT population.
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-tenosynovial-giant-cell-tumor
nct id
NCT02371369
qol key
qol-0013
source section id
NCT02371369-om-0013
source outcome index
13
instrument
PROMIS
instrument basis
matched 'promis' in the study's own wording
scale title
Mean Change From Baseline in the Patient-reported Outcomes Measurement Information System (PROMIS) Physical Function Score in Participants Receiving Pexidartinib Compared With Those on Placebo by Week 49
measure definition
The Patient-reported Outcomes Measurement Information System (PROMIS) physical function scale was used to assess physical function of the upper and lower limbs. The scale ranged from 1 defined as 'unable to do' or 'cannot do' to 5 defined as 'without any difficulty' or 'not at all', where higher scores represent better outcomes.
time frame
By Week 49
analysis role
exploratory
reporting status
POSTED
higher is better
1
direction quote
higher scores represent better
population note
Physical function was assessed in the ITT population.
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-tenosynovial-giant-cell-tumor
nct id
NCT02371369
qol key
qol-0015
source section id
NCT02371369-om-0015
source outcome index
15
instrument
Brief Pain Inventory
instrument basis
matched 'brief pain inventory' in the study's own wording
scale title
Mean Change From Baseline for Worst Pain Numeric Rating Scale Score (NRS) in Participants Receiving Pexidartinib Compared With Those on Placebo by Week 49
measure definition
The Brief Pain Inventory (BPI) Worst Pain NRS was a 1-item, self-administered questionnaire assessing the "worst" pain in the last 24 hours. The NRS for this item ranged from 0 (no pain) to 10 (pain as bad as you can imagine).
time frame
By Week 49
analysis role
exploratory
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Worst pain was assessed in the ITT population, specifically among the Pexidartinib Part 1, Pexidartinib Part 2; Placebo Part 1, Pexidartinib Part 2; and All Pexidartinib Treated participants. Participants who received Placebo Part 1 only or Pexidartinib Part 2 only were not analyzed.
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