NCT00680992 · OUTCOME
Number of Participants Who Experienced the Maximum Toxicity Grade (CTCAE Grade ≥ 3) in the Indicated Clinical Chemistry Parameters
Study of Denosumab in Subjects With Giant Cell Tumor of Bone · Source last updated 2022-09-22
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Baseline (day 1) up to last study visit for initial treatment phase (median duration approximately 30 months up to a maximum of approximately 109 months).
What was measured
Serum samples for clinical chemistry were collected on study day 1 (baseline), day 15, week 5 and each study visit Q4W thereafter until last study visit for the on-study period (ie, until end of initial treatment phase). The parameters included albumin, calcium (albumin-adjusted), creatinine, magnesium and phosphate. Results are presented for number of participants who experienced the maximum toxicity grade for each of these clinical parameters. The maximum toxicity grade experienced by each participant was based on CTCAE, v3.0, and are summarized for Grade 3 and 4. Increases and decreases in relationship to the normal parameter ranges are indicated as 'Above' and 'Below' respectively.
Analysis population: The safety analysis set included all enrolled participants who received at least one dose of denosumab on the study.
Groups in this outcome
Cohort 1 (Denosumab 120 mg Q4W)
Participants with surgically unsalvageable disease (eg, sacral, spinal GCTB, or multiple lesions including pulmonary metastases) were enrolled into cohort 1 and received denosumab 120 mg SC once Q4W, starting on study day 1, plus loading doses of 120 mg SC on days 8 and 15 in the first month of treatment.
Cohort 2 (Denosumab 120 mg Q4W)
Participants with surgically salvageable disease whose planned initial on-study surgery was associated with severe morbidity (eg, joint resection, limb amputation, or hemipelvectomy) were enrolled into cohort 2 and received denosumab 120 mg SC Q4W, starting on study day 1, plus loading doses of 120 mg SC on days 8 and 15 in the first month of treatment.
Cohort 3 (Denosumab 120 mg Q4W)
Participants who participated in study 20040215 and were eligible to enroll in the current study (20062004) for continuation of treatment were enrolled into cohort 3 and received denosumab 120 mg SC Q4W, starting on study day 1. Participants in cohort 3 did not receive loading doses of denosumab on days 8 and 15 in the first month of treatment.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort 1 (Denosumab 120 mg Q4W) | 265 |
|---|
| Cohort 2 (Denosumab 120 mg Q4W) | 249 |
|---|
| Cohort 3 (Denosumab 120 mg Q4W) | 12 |
|---|
Reported measurements
Calcium corrected Grade 3 (Above)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1 (Denosumab 120 mg Q4W) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 2 (Denosumab 120 mg Q4W) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 3 (Denosumab 120 mg Q4W) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Calcium corrected Grade 4 (Above)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1 (Denosumab 120 mg Q4W) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 2 (Denosumab 120 mg Q4W) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 3 (Denosumab 120 mg Q4W) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Calcium corrected Grade 3 (Below)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1 (Denosumab 120 mg Q4W) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 2 (Denosumab 120 mg Q4W) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 3 (Denosumab 120 mg Q4W) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Calcium corrected Grade 4 (Below)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1 (Denosumab 120 mg Q4W) | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 2 (Denosumab 120 mg Q4W) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 3 (Denosumab 120 mg Q4W) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Phosphate Grade 3 (Below)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1 (Denosumab 120 mg Q4W) | 60 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 2 (Denosumab 120 mg Q4W) | 41 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 3 (Denosumab 120 mg Q4W) | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Magnesium Grade 3 (Above)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1 (Denosumab 120 mg Q4W) | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 2 (Denosumab 120 mg Q4W) | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 3 (Denosumab 120 mg Q4W) | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Magnesium Grade 3 (Below)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1 (Denosumab 120 mg Q4W) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 2 (Denosumab 120 mg Q4W) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 3 (Denosumab 120 mg Q4W) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Creatinine Grade 3 (Above)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1 (Denosumab 120 mg Q4W) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 2 (Denosumab 120 mg Q4W) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 3 (Denosumab 120 mg Q4W) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Albumin Grade 3 (Below)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1 (Denosumab 120 mg Q4W) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 2 (Denosumab 120 mg Q4W) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 3 (Denosumab 120 mg Q4W) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- title
- Calcium corrected Grade 3 (Above)
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- title
- Calcium corrected Grade 4 (Above)
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Calcium corrected Grade 3 (Below)
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Calcium corrected Grade 4 (Below)
- categories
- measurements
- group Id
- OG000
- value
- 60
- group Id
- OG001
- value
- 41
- group Id
- OG002
- value
- 4
- title
- Phosphate Grade 3 (Below)
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 2
- title
- Magnesium Grade 3 (Above)
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Magnesium Grade 3 (Below)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- title
- Creatinine Grade 3 (Above)
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Albumin Grade 3 (Below)
- denoms
- counts
- group Id
- OG000
- value
- 265
- group Id
- OG001
- value
- 249
- group Id
- OG002
- value
- 12
- units
- Participants
- description
- Serum samples for clinical chemistry were collected on study day 1 (baseline), day 15, week 5 and each study visit Q4W thereafter until last study visit for the on-study period (ie, until end of initial treatment phase). The parameters included albumin, calcium (albumin-adjusted), creatinine, magnesium and phosphate. Results are presented for number of participants who experienced the maximum toxicity grade for each of these clinical parameters. The maximum toxicity grade experienced by each participant was based on CTCAE, v3.0, and are summarized for Grade 3 and 4. Increases and decreases in relationship to the normal parameter ranges are indicated as 'Above' and 'Below' respectively.
- groups
- description
- Participants with surgically unsalvageable disease (eg, sacral, spinal GCTB, or multiple lesions including pulmonary metastases) were enrolled into cohort 1 and received denosumab 120 mg SC once Q4W, starting on study day 1, plus loading doses of 120 mg SC on days 8 and 15 in the first month of treatment.
- id
- OG000
- title
- Cohort 1 (Denosumab 120 mg Q4W)
- description
- Participants with surgically salvageable disease whose planned initial on-study surgery was associated with severe morbidity (eg, joint resection, limb amputation, or hemipelvectomy) were enrolled into cohort 2 and received denosumab 120 mg SC Q4W, starting on study day 1, plus loading doses of 120 mg SC on days 8 and 15 in the first month of treatment.
- id
- OG001
- title
- Cohort 2 (Denosumab 120 mg Q4W)
- description
- Participants who participated in study 20040215 and were eligible to enroll in the current study (20062004) for continuation of treatment were enrolled into cohort 3 and received denosumab 120 mg SC Q4W, starting on study day 1. Participants in cohort 3 did not receive loading doses of denosumab on days 8 and 15 in the first month of treatment.
- id
- OG002
- title
- Cohort 3 (Denosumab 120 mg Q4W)
- param Type
- NUMBER
- population Description
- The safety analysis set included all enrolled participants who received at least one dose of denosumab on the study.
- reporting Status
- POSTED
- time Frame
- Baseline (day 1) up to last study visit for initial treatment phase (median duration approximately 30 months up to a maximum of approximately 109 months).
- title
- Number of Participants Who Experienced the Maximum Toxicity Grade (CTCAE Grade ≥ 3) in the Indicated Clinical Chemistry Parameters
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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