NCT01942135 · OUTCOME
Participants With Shifts From CTCAE Grade ≤2 at Baseline to CTCAE Grade 3 or 4 Postbaseline for Hematology Results
Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3) · Source last updated 2024-04-04
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From baseline to end of treatment/withdrawal (up to 4.5 years)
What was measured
Number of participants with shifts from Grade ≤2 at baseline values to post-baseline values (shift to Grade 3 or 4) were reported as per NCI-CTCAE, V4.0 graded from Grade 1 to 5. Grade 1: Mild; asymptomatic/ mild symptoms; clinical/diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local/noninvasive intervention indicated. Grade 3: Severe/medically significant but not immediately life-threatening; hospitalization/prolongation of hospitalization indicated. Grade 4: Life-threatening consequences; urgent intervention indicated. Shifts in lab parameter from Grade ≤2 at baseline to Grade 3 or 4 postbaseline (for parameters Anemia, Hemoglobin increased, Neutrophil count decreased, Platelet count decreased, and White blood cell count decreased) were reported.
Analysis population: The as-treated (AT) population or safety analysis set included all participants who received at least 1 dose of study intervention, with treatment assignments designated according to actual study intervention received.
Groups in this outcome
Palbociclib + Fulvestrant
Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase. Maximum treatment duration was 105 cycles.
Placebo + Fulvestrant
Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase. Maximum treatment duration was 93 cycles.
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 |
|---|
| Palbociclib + Fulvestrant | 345 |
|---|
| Placebo + Fulvestrant | 172 |
|---|
Reported measurements
Anemia
Analysis denominator · Participants
| Group | Source count |
|---|
| Palbociclib + Fulvestrant | 343 |
|---|
| Placebo + Fulvestrant | 171 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Palbociclib + Fulvestrant | 16 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo + Fulvestrant | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Hemoglobin increased
Analysis denominator · Participants
| Group | Source count |
|---|
| Palbociclib + Fulvestrant | 343 |
|---|
| Placebo + Fulvestrant | 171 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Palbociclib + Fulvestrant | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo + Fulvestrant | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Neutrophil count decreased
Analysis denominator · Participants
| Group | Source count |
|---|
| Palbociclib + Fulvestrant | 342 |
|---|
| Placebo + Fulvestrant | 171 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Palbociclib + Fulvestrant | 239 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo + Fulvestrant | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Platelet count decreased
Analysis denominator · Participants
| Group | Source count |
|---|
| Palbociclib + Fulvestrant | 343 |
|---|
| Placebo + Fulvestrant | 171 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Palbociclib + Fulvestrant | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo + Fulvestrant | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
White blood cell count decreased
Analysis denominator · Participants
| Group | Source count |
|---|
| Palbociclib + Fulvestrant | 343 |
|---|
| Placebo + Fulvestrant | 171 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Palbociclib + Fulvestrant | 167 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo + Fulvestrant | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 3
- denoms
- counts
- group Id
- OG000
- value
- 343
- group Id
- OG001
- value
- 171
- units
- Participants
- title
- Anemia
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 343
- group Id
- OG001
- value
- 171
- units
- Participants
- title
- Hemoglobin increased
- categories
- measurements
- group Id
- OG000
- value
- 239
- group Id
- OG001
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 342
- group Id
- OG001
- value
- 171
- units
- Participants
- title
- Neutrophil count decreased
- categories
- measurements
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 343
- group Id
- OG001
- value
- 171
- units
- Participants
- title
- Platelet count decreased
- categories
- measurements
- group Id
- OG000
- value
- 167
- group Id
- OG001
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 343
- group Id
- OG001
- value
- 171
- units
- Participants
- title
- White blood cell count decreased
- denoms
- counts
- group Id
- OG000
- value
- 345
- group Id
- OG001
- value
- 172
- units
- Participants
- description
- Number of participants with shifts from Grade ≤2 at baseline values to post-baseline values (shift to Grade 3 or 4) were reported as per NCI-CTCAE, V4.0 graded from Grade 1 to 5. Grade 1: Mild; asymptomatic/ mild symptoms; clinical/diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local/noninvasive intervention indicated. Grade 3: Severe/medically significant but not immediately life-threatening; hospitalization/prolongation of hospitalization indicated. Grade 4: Life-threatening consequences; urgent intervention indicated. Shifts in lab parameter from Grade ≤2 at baseline to Grade 3 or 4 postbaseline (for parameters Anemia, Hemoglobin increased, Neutrophil count decreased, Platelet count decreased, and White blood cell count decreased) were reported.
- groups
- description
- Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase. Maximum treatment duration was 105 cycles.
- id
- OG000
- title
- Palbociclib + Fulvestrant
- description
- Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase. Maximum treatment duration was 93 cycles.
- id
- OG001
- title
- Placebo + Fulvestrant
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The as-treated (AT) population or safety analysis set included all participants who received at least 1 dose of study intervention, with treatment assignments designated according to actual study intervention received.
- reporting Status
- POSTED
- time Frame
- From baseline to end of treatment/withdrawal (up to 4.5 years)
- title
- Participants With Shifts From CTCAE Grade ≤2 at Baseline to CTCAE Grade 3 or 4 Postbaseline for Hematology Results
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
Triangle