NCT00396279 · OUTCOME
Number of Participants With Adverse Events (AEs)
Safety and Efficacy Study of Denosumab in Patients With Recurrent or Unresectable Giant Cell Tumor of Bone · Source last updated 2022-11-08
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
- From the first dose of study drug until the data cut-off date of April 7 2008; a maximum of 18 months
What was measured
An adverse event is defined as an undesirable medical occurrence (e.g., sign, symptom, or diagnosis) or worsening of a pre-existing medical condition. A serious adverse event (SAE) is defined by regulatory authorities as one that • is fatal • is life threatening (places the participant at immediate risk of death) • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard. The severity of adverse events was assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, version 3.0) based on the following general guideline: Grade 1: Mild AE Grade 2: Moderate AE Grade 3: Severe AE Grade 4: Life-threatening or disabling AE Grade 5: Death related to AE. AEs were assessed by the Investigator for relatedness to study drug.
Analysis population: All participants who received at least 1 dose of denosumab.
Groups in this outcome
Denosumab
Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
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 |
|---|
| Denosumab | 37 |
|---|
Reported measurements
Any AE
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Denosumab | 33 | Not reported | Not reported | Not reported | Not reported |
|---|
Serious AE
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Denosumab | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
Fatal AE
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Denosumab | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
AE leading to study discontinuation
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Denosumab | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
AE leading to study drug discontinuation
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Denosumab | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
CTCAE Grade 3, 4, or 5
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Denosumab | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
Any AE related to study drug
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Denosumab | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- title
- Any AE
- title
- Serious AE
- title
- Fatal AE
- title
- AE leading to study discontinuation
- title
- AE leading to study drug discontinuation
- title
- CTCAE Grade 3, 4, or 5
- title
- Any AE related to study drug
- description
- An adverse event is defined as an undesirable medical occurrence (e.g., sign, symptom, or diagnosis) or worsening of a pre-existing medical condition. A serious adverse event (SAE) is defined by regulatory authorities as one that • is fatal • is life threatening (places the participant at immediate risk of death) • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard. The severity of adverse events was assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, version 3.0) based on the following general guideline: Grade 1: Mild AE Grade 2: Moderate AE Grade 3: Severe AE Grade 4: Life-threatening or disabling AE Grade 5: Death related to AE. AEs were assessed by the Investigator for relatedness to study drug.
- groups
- description
- Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
- id
- OG000
- title
- Denosumab
- param Type
- NUMBER
- population Description
- All participants who received at least 1 dose of denosumab.
- reporting Status
- POSTED
- time Frame
- From the first dose of study drug until the data cut-off date of April 7 2008; a maximum of 18 months
- title
- Number of Participants With Adverse Events (AEs)
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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