Trial Outcomes & Findings for An Investigational Study Drug, Palbociclib (PD-0332991), Is Being Studied In Patients With Mantle Cell Lymphoma. Patients Must Have Received Prior Treatment(s) For Mantle Cell Lymphoma. (NCT NCT00420056)
NCT ID: NCT00420056
Last Updated: 2015-10-28
Results Overview
Maximum standard uptake value (SUVmax) was defined as the maximum value attained for the ratio of tissue radioactivity concentration at any time and the injected radioactivity concentration divided by the body weight (in kilogram \[kg\]). Phosphorylation of retinoblastoma (Rb) protein in the tumor cells, expressed as phospho-Rb percent positive cells, was assessed using Immunohistochemical staining technique. Change from baseline in \[(18)F\]-FLT-PET SUVmax at Cycle 1 Day 21 and change from baseline in Phospho-Rb percent positive cells at Cycle 1 Day 21 were analyzed. The change values of FLT-PET SUVmax and Phospho-Rb percent positive cells were then correlated. Here, 'N' (number of participants analyzed) signifies participants evaluable for this measure.
COMPLETED
PHASE1
17 participants
Baseline, Cycle 1 Day 21
2015-10-28
Participant Flow
Participant milestones
| Measure |
PD 0332991
PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion.
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Overall Study
STARTED
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17
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Overall Study
COMPLETED
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0
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Overall Study
NOT COMPLETED
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17
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Reasons for withdrawal
| Measure |
PD 0332991
PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion.
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Overall Study
Objective progression or relapse
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17
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Baseline Characteristics
An Investigational Study Drug, Palbociclib (PD-0332991), Is Being Studied In Patients With Mantle Cell Lymphoma. Patients Must Have Received Prior Treatment(s) For Mantle Cell Lymphoma.
Baseline characteristics by cohort
| Measure |
PD 0332991
n=17 Participants
PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion.
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Age, Continuous
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66.1 years
STANDARD_DEVIATION 9.2 • n=5 Participants
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Sex: Female, Male
Female
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3 Participants
n=5 Participants
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Sex: Female, Male
Male
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14 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline, Cycle 1 Day 21Population: SUVmax was analyzed using imaging analysis set (participants in FAS who completed baseline \[(18)F\]-fluorodeoxyglucose PET \[FDG-PET\] and \[(18)F\]-FLT-PET, and at least 1 on-treatment \[Day 21\] PET) and phospho-Rb was analyzed using tumor analysis set (participants in FAS who completed tumor biomarker assessments at baseline and Day 21).
Maximum standard uptake value (SUVmax) was defined as the maximum value attained for the ratio of tissue radioactivity concentration at any time and the injected radioactivity concentration divided by the body weight (in kilogram \[kg\]). Phosphorylation of retinoblastoma (Rb) protein in the tumor cells, expressed as phospho-Rb percent positive cells, was assessed using Immunohistochemical staining technique. Change from baseline in \[(18)F\]-FLT-PET SUVmax at Cycle 1 Day 21 and change from baseline in Phospho-Rb percent positive cells at Cycle 1 Day 21 were analyzed. The change values of FLT-PET SUVmax and Phospho-Rb percent positive cells were then correlated. Here, 'N' (number of participants analyzed) signifies participants evaluable for this measure.
Outcome measures
| Measure |
PD 0332991
n=10 Participants
PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion.
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Correlation Coefficient Between Change From Baseline in Fluoro-L-thymidine Positron Emission Tomography (FLT-PET) Maximum Standard Uptake Value (SUVmax) and in Phosphorylated Retinoblastoma (Phospho-Rb) Percent Positive Cells at Cycle 1 Day 21
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-0.25034 correlation coefficient
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PRIMARY outcome
Timeframe: Baseline, Cycle 1 Day 21Population: SUVmax was analyzed using imaging analysis set (participants in FAS who completed baseline \[(18)F\]-FDG-PET and \[(18)F\]-FLT-PET, and at least 1 on-treatment \[Day 21\] PET) and phospho-Rb was analyzed using tumor analysis set (participants in FAS who completed tumor biomarker assessments at baseline and Day 21).
Maximum standard uptake value (SUVmax) was defined as the maximum value attained for the ratio of tissue radioactivity concentration at any time and the injected radioactivity concentration divided by the body weight (in kilogram \[kg\]). Phosphorylation of retinoblastoma (Rb) protein in the tumor cells, expressed as phospho-Rb percent positive cells, was assessed using Immunohistochemical staining technique. Change from baseline in \[(18)F\]-FDG-PET SUVmax at Cycle 1 Day 21 and change from baseline in Phospho-Rb percent positive cells at Cycle 1 Day 21 were analyzed. The change values of FLT-PET SUVmax and Phospho-Rb percent positive cells were then correlated. Here, 'N' (number of participants analyzed) signifies participants evaluable for this measure.
Outcome measures
| Measure |
PD 0332991
n=10 Participants
PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion.
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Correlation Coefficient Between Change From Baseline in Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Maximum Standard Uptake Value (SUVmax) and in Phosphorylated Retinoblastoma (Phospho-Rb) Percent Positive Cells at Cycle 1 Day 21
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0.13551 correlation coefficient
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PRIMARY outcome
Timeframe: Baseline, Cycle 1 Day 21Population: Imaging analysis set included participants in FAS who completed baseline \[(18)F\]-FDG-PET and \[(18)F\]-FLT-PET, and at least 1 on-treatment (Day 21) PET.
Maximum standard uptake value (SUVmax) was defined as the maximum value attained for the ratio of tissue radioactivity concentration at any time and the injected radioactivity concentration divided by the body weight (in kilogram \[kg\]). Change from baseline in SUVmax was assessed using \[(18)F\]-FLT-PET and \[(18)F\]-FDG-PET techniques.
Outcome measures
| Measure |
PD 0332991
n=17 Participants
PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion.
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Change From Baseline in Maximum Standard Uptake Value (SUVmax) at Cycle 1 Day 21
Baseline: FDG-PET
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9.049 standard uptake value (SUV)
Standard Deviation 4.654
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Change From Baseline in Maximum Standard Uptake Value (SUVmax) at Cycle 1 Day 21
Baseline: FLT-PET
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9.964 standard uptake value (SUV)
Standard Deviation 4.929
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Change From Baseline in Maximum Standard Uptake Value (SUVmax) at Cycle 1 Day 21
Change at Cycle 1 Day 21: FLT-PET
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-4.551 standard uptake value (SUV)
Standard Deviation 2.968
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Change From Baseline in Maximum Standard Uptake Value (SUVmax) at Cycle 1 Day 21
Change at Cycle 1 Day 21: FDG-PET
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-2.271 standard uptake value (SUV)
Standard Deviation 2.913
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PRIMARY outcome
Timeframe: Baseline, Cycle 1 Day 21 for PET response; Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks) for PFSPopulation: Analysis for this outcome measure was not run as there were so few responders.
PET response was defined as complete response (CR) = mean SUVmax same as of background; partial response (PR) = mean SUVmax less than (\<) 75 percent (%) of baseline; progressive disease (PD) = mean SUVmax greater than (\>) 125% of baseline; stable disease (SD) = mean SUVmax greater than or equal to (\>=) 75% of baseline and mean SUVmax less than or equal to (\<=) 125% of baseline. PFS was defined as the time from first dose of study medication to the first documentation of objective tumor progression, or to death due to any cause, whichever occurred first. Tumor progression was defined as \>50% increase in sum of products of diameters, of dominant nodes and documented non-nodal sites or appearance of new sites of disease.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, Cycle 1 Day 21 for PET response; Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks) for ORPopulation: PET response was analyzed using Imaging analysis set and OR was analyzed using response analysis set (all participants enrolled in the study who received at least 1 dose of study medication in cycle 1 and for whom a post-treatment response assessment was completed).
OR: CR= disappearance of all clinical/radiographic evidence of disease, disease related symptoms and biochemical abnormalities, nodal masses regressed to normal size, if spleen and bone marrow were involved, spleen regressed to normal size and not palpable and clear infiltrate on repeat bone marrow aspiration; PR= dominant nodes decreased by \>50% in sum of products of diameters (SPD), no increase in size of other nodes/liver/spleen, lesions regressed by \>50% in SPD, no new sites of disease; SD= response \<PR and no PD, documented \>=1 time after start of therapy, no new sites of disease; PD= \>50% increase in SPD of dominant nodes and other nodes or appearance of new sites of disease. PET response: CR= mean SUVmax same as background; PR= mean SUVmax \<75% of baseline; PD= mean SUVmax \>125% of baseline; SD= mean SUVmax \>=75% of baseline but \<=125% of baseline. Correlation was reported as conjoint number of participants with PET response at Cycle 1 Day 21 and OR at end of study.
Outcome measures
| Measure |
PD 0332991
n=17 Participants
PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion.
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Correlation Between Positron Emission Tomography (PET) Response and Objective Response (OR)
FLT-PET PR, Objective PD
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4 participants
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Correlation Between Positron Emission Tomography (PET) Response and Objective Response (OR)
FLT-PET PR, Objective CR
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1 participants
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Correlation Between Positron Emission Tomography (PET) Response and Objective Response (OR)
FLT-PET PR, Objective PR
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2 participants
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Correlation Between Positron Emission Tomography (PET) Response and Objective Response (OR)
FLT-PET PR, Objective SD
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7 participants
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Correlation Between Positron Emission Tomography (PET) Response and Objective Response (OR)
FLT-PET PR, Indetermined Objective Response
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1 participants
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Correlation Between Positron Emission Tomography (PET) Response and Objective Response (OR)
FLT-PET SD, Objective PD
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2 participants
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Correlation Between Positron Emission Tomography (PET) Response and Objective Response (OR)
FDG-PET PR, Objective PR
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2 participants
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Correlation Between Positron Emission Tomography (PET) Response and Objective Response (OR)
FDG-PET PR, Objective SD
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3 participants
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Correlation Between Positron Emission Tomography (PET) Response and Objective Response (OR)
FDG-PET PR, Objective PD
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2 participants
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|
Correlation Between Positron Emission Tomography (PET) Response and Objective Response (OR)
FDG-PET SD, Objective CR
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1 participants
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Correlation Between Positron Emission Tomography (PET) Response and Objective Response (OR)
FDG-PET SD, Objective SD
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4 participants
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Correlation Between Positron Emission Tomography (PET) Response and Objective Response (OR)
FDG-PET SD, Objective PD
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4 participants
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Correlation Between Positron Emission Tomography (PET) Response and Objective Response (OR)
FDG-PET SD, Objective Indetermined Response
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1 participants
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PRIMARY outcome
Timeframe: BaselinePopulation: Tumor analysis set include all participants in FAS who completed tumor biomarker assessments at baseline and Day 21. Here, 'N' (number of participants analyzed) signifies participants evaluable for this measure.
Phosphorylation of retinoblastoma (Rb) protein in the tumor cells, expressed as phospho-Rb percent positive cells, was assessed using Immunohistochemical staining technique.
Outcome measures
| Measure |
PD 0332991
n=10 Participants
PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion.
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Phosphorylated Retinoblastoma (Phospho-Rb) Percent Positive Cells at Baseline
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47.9 percentage of tumor cells
Standard Deviation 25.72
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PRIMARY outcome
Timeframe: Cycle 1 Day 21Population: Tumor analysis set include all participants in FAS who completed tumor biomarker assessments at baseline and Day 21. Here, 'N' (number of participants analyzed) signifies participants evaluable for this measure.
Phosphorylation of retinoblastoma (Rb) protein in the tumor cells, expressed as phospho-Rb percent positive cells, was assessed using Immunohistochemical staining technique.
Outcome measures
| Measure |
PD 0332991
n=10 Participants
PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion.
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Phosphorylated Retinoblastoma (Phospho-Rb) Percent Positive Cells at Cycle 1 Day 21
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7.2 percentage of tumor cells
Standard Deviation 14.4
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PRIMARY outcome
Timeframe: BaselinePopulation: Tumor analysis set include all participants in FAS who completed tumor biomarker assessments at baseline and Day 21. Here, 'N' (number of participants analyzed) signifies participants evaluable for this measure.
Percentage of Ki-67 positive cells was determined by Immunohistochemical staining technique. Composite score = (sum of each intensity category multiplied by percent of cells in that category). Intensity categories of staining (0 = no staining; 1 = weak staining; 2 = moderate staining; 3 = strong staining). Composite score ranges from 0 (no staining) to 300 (100% of cells with 3 staining intensity).
Outcome measures
| Measure |
PD 0332991
n=6 Participants
PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion.
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Ki-67 Composite Score at Baseline
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191.2 units on a scale
Standard Deviation 64.56
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PRIMARY outcome
Timeframe: Cycle 1 Day 21Population: Tumor analysis set include all participants in FAS who completed tumor biomarker assessments at baseline and Day 21. Here, 'N' (number of participants analyzed) signifies participants evaluable for this measure.
Percentage of Ki-67 positive cells was determined by Immunohistochemical staining technique. Composite score = (sum of each intensity category multiplied by percent of cells in that category). Intensity categories of staining (0 = no staining; 1 = weak staining; 2 = moderate staining; 3 = strong staining). Composite score ranges from 0 (no staining) to 300 (100% of cells with 3 staining intensity).
Outcome measures
| Measure |
PD 0332991
n=6 Participants
PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion.
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Ki-67 Composite Score at Cycle 1 Day 21
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78.5 units on a scale
Standard Deviation 110.02
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PRIMARY outcome
Timeframe: BaselinePopulation: Tumor analysis set include all participants in FAS who completed tumor biomarker assessments at baseline and Day 21. Here, 'N' (number of participants analyzed) signifies participants evaluable for this measure.
Percentage of Cyclin D1 positive cells was determined by Immunohistochemical staining technique. Composite score = (sum of each intensity category multiplied by percent of cells in that category). Intensity categories of staining (0 = no staining; 1 = weak staining; 2 = moderate staining; 3 = strong staining). Composite score ranges from 0 (no staining) to 300 (100% of cells with 3 staining intensity).
Outcome measures
| Measure |
PD 0332991
n=6 Participants
PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion.
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Cyclin D1 Composite Score at Baseline
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165.0 units on a scale
Standard Deviation 78.17
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PRIMARY outcome
Timeframe: Cycle 1 Day 21Population: Tumor analysis set include all participants in FAS who completed tumor biomarker assessments at baseline and Day 21. Here, 'N' (number of participants analyzed) signifies participants evaluable for this measure.
Percentage of Cyclin D1 positive cells was determined by Immunohistochemical staining technique. Composite score = (sum of each intensity category multiplied by percent of cells in that category). Intensity categories of staining (0 = no staining; 1 = weak staining; 2 = moderate staining; 3 = strong staining). Composite score ranges from 0 (no staining) to 300 (100% of cells with 3 staining intensity).
Outcome measures
| Measure |
PD 0332991
n=6 Participants
PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion.
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Cyclin D1 Composite Score at Cycle 1 Day 21
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124.2 units on a scale
Standard Deviation 47.58
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PRIMARY outcome
Timeframe: Baseline up to 28 days after last dose of study medicationPopulation: Safety analysis set included all participants enrolled in the study who received at least 1 dose of study medication.
Criteria for laboratory test abnormality: Hematology (Hemoglobin \[\<0.8\*lower limit of normal {LLN}\], Platelets \[\<0.5\*LLN/ \>1.75\*upper limit of normal {ULN}\], White blood cells \[\<0.6\*LLN/ \>1.5\*ULN\], Lymphocytes, Neutrophils \[\<0.8\*LLN/ \>1.2\*ULN\], Basophils, Eosinophils, Monocytes \[\>1.2\*ULN\]); Liver Function (Total bilirubin \[\>1.5\*ULN\], Aspartate aminotransferase, Alanine aminotransferase, Lactate dehydrogenase, Alkaline phosphatase \[\>0.3\*ULN\], Total protein, Albumin \[\<0.8\*LLN/ \>1.2\*ULN\]); Renal Function (Blood urea nitrogen, Creatinine \[\>1.3\*ULN\], Uric acid \[\>1.2\*ULN\]); Electrolytes (sodium \[\<0.95\*LLN/ \>1.05\*ULN\], potassium, chloride, calcium, magnesium \[\<0.9\*LLN/ \>1.1\*ULN\], phosphate \[\<0.8\*LLN/ \>1.2\*ULN\]); Other (Glucose \[\<0.6\*LLN/ \>1.5\*ULN\]).
Outcome measures
| Measure |
PD 0332991
n=17 Participants
PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion.
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Number of Participants With Laboratory Test Abnormalities
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16 participants
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PRIMARY outcome
Timeframe: Day 1 up to 28 days after last dose of study medicationPopulation: Safety analysis set included all participants enrolled in the study who received at least 1 dose of study medication.
AE = any untoward medical occurrence in participant who received study medication without regard to possibility of causal relationship. Severity was assessed as: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe) = unacceptable or intolerable events, significantly interrupting usual daily activity, and requiring systemic medication therapy/other treatment; Grade 4 (Life-threatening) = events causing participant to be in imminent danger of death; Grade 5 (Death) = death related to an AE. Treatment-emergent events = between first dose of study medication and up to 28 days after last dose, that were absent before treatment or that worsened relative to pre-treatment state. A participant may be represented in more than 1 category.
Outcome measures
| Measure |
PD 0332991
n=17 Participants
PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion.
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Number of Participants With Treatment-Emergent Adverse Events by Severity
Grade 2
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2 participants
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Number of Participants With Treatment-Emergent Adverse Events by Severity
Grade 1
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4 participants
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Number of Participants With Treatment-Emergent Adverse Events by Severity
Grade 3
|
7 participants
|
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Number of Participants With Treatment-Emergent Adverse Events by Severity
Grade 4
|
3 participants
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Number of Participants With Treatment-Emergent Adverse Events by Severity
Grade 5
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1 participants
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PRIMARY outcome
Timeframe: Day 1 up to 28 days after last dose of study medicationPopulation: Safety analysis set included all participants enrolled in the study who received at least 1 dose of study medication.
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The events which were considered treatment-related by sponsor and/or investigator were reported.
Outcome measures
| Measure |
PD 0332991
n=17 Participants
PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion.
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|---|---|
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Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
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16 participants
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Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
2 participants
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SECONDARY outcome
Timeframe: Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks)Population: Response analysis set included all participants enrolled in the study who received at least 1 dose of study medication in cycle 1 and for whom a post-treatment response assessment was completed.
PFS was defined as the time from first dose of study medication to the first documentation of objective tumor progression, or to death due to any cause, whichever occurred first. Tumor progression was defined as \>50% increase in sum of products of diameters, of dominant nodes and documented non-nodal sites or appearance of new sites of disease. PFS= (first event date minus the first dose date plus 1) divided by 30.44.
Outcome measures
| Measure |
PD 0332991
n=16 Participants
PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion.
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|---|---|
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Progression-Free Survival (PFS)
|
5.5 months
Interval 2.0 to 18.6
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SECONDARY outcome
Timeframe: Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks)Population: Response analysis set included all participants enrolled in the study who received at least 1 dose of study medication in cycle 1 and for whom a post-treatment response assessment was completed.
OR is defined as the percentage of participants with confirmed complete response (CR) or confirmed partial response (PR). Confirmed responses are those that persist on repeat imaging study 4 weeks after initial documentation of response. Complete response (CR)= disappearance of all detectable clinical/radiographic evidence of disease, disease related symptoms present before therapy and biochemical abnormalities attributable to disease, nodal masses regressed to normal size, if spleen and bone marrow were involved, spleen regressed to normal size and not palpable and clear infiltrate on repeated bone marrow aspiration; Partial response (PR)= dominant nodes decreased by \>50% in sum of products of diameters (SPD), no increase in size of other nodes/liver/spleen, lesions in organs (spleen/liver) regressed by \>50% in SPD, no new sites of disease.
Outcome measures
| Measure |
PD 0332991
n=16 Participants
PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion.
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|---|---|
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Percentage of Participants With Objective Response
|
18.8 percentage of participants
Interval 4.0 to 45.6
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SECONDARY outcome
Timeframe: Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks)Population: For duration of response, the number of participants experiencing objective response was less than 50%, and therefore, it was not feasible to calculate duration of response using Kaplan-Meier method. Hence, no participant was analyzed for this outcome measure.
Time in months from first documentation of objective tumor response (CR or PR) that was subsequently confirmed, to objective tumor progression (PD) or death due to any cause. DR= (date of first documentation of PD or death, minus the date of first CR or PR plus 1) divided by 30.44. CR= disappearance of all detectable clinical/radiographic evidence of disease, disease related symptoms present before start of therapy and biochemical abnormalities attributable to disease, nodal masses regressed to normal size, if spleen and bone marrow were involved, spleen regressed to normal size and not palpable and clear infiltrate on repeated bone marrow aspiration. PR= dominant nodes decreased by \>50% in sum of products of diameters (SPD), no increase in size of other nodes/liver/spleen, lesions in organs (spleen/liver) regressed by \>50% in SPD, no new sites of disease. PD= \>50% increase in SPD of dominant nodes and other nodes or appearance of new sites of disease.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks)Population: Response analysis set included all participants enrolled in the study who received at least 1 dose of study medication in cycle 1 and for whom a post-treatment response assessment was completed.
Time in months from date of first dose of study medication to first documentation of objective tumor progression (PD). TTP= (last known progression-free date minus date of first dose of study medication plus 1) divided by 30.44. PD was defined as greater than 50% increase in sum of products of diameters, of dominant nodes and documented non-nodal sites or appearance of new sites of disease.
Outcome measures
| Measure |
PD 0332991
n=16 Participants
PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion.
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|---|---|
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Time to Tumor Progression (TTP)
|
5.5 months
Interval 2.0 to 18.6
|
SECONDARY outcome
Timeframe: Baseline, Cycle 1 Day 21Population: PD 0332991 concentration was analyzed using pharmacokinetic analysis set (participants in FAS who had also completed pharmacokinetic blood sampling for at least 1 day); SUVmax and biomarkers were analyzed using imaging analysis set and tumor analysis set respectively. n= participants evaluable for this measure for specified comparisons.
Plasma PD 0332991 concentration at Cycle 1 Day 21 was analyzed. Change from baseline in biomarkers (Ki-67 composite score, Cyclin D1 composite score, phospho-Rb positive cells) and SUVmax (FLT-PET SUVmax, FDG-PET SUVmax) at Cycle 1 Day 21 were analyzed. Correlation between PD 0332991 concentration and change in biomarkers (concentration versus Ki-67, concentration versus Cyclin, and concentration versus phospho-Rb) and SUVmax (concentration versus FLT-PET SUVmax, concentration versus FDG-PET SUVmax) was then assessed. Composite score = (sum of each intensity category multiplied by percent of cells in that category). Intensity categories of staining (0 = no staining; 1 = weak staining; 2 = moderate staining; 3 = strong staining). Here, 'N' (number of participants analyzed) signifies participants evaluable for this measure.
Outcome measures
| Measure |
PD 0332991
n=16 Participants
PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion.
|
|---|---|
|
Correlation Coefficient Between Plasma PD 0332991 Concentration and Change From Baseline in Biomarkers and SUVmax at Cycle 1 Day 21
Concentration versus Ki-67 (n=6)
|
0.27677 correlation coefficient
|
|
Correlation Coefficient Between Plasma PD 0332991 Concentration and Change From Baseline in Biomarkers and SUVmax at Cycle 1 Day 21
Concentration versus Cyclin D1 (n= 6)
|
-0.69081 correlation coefficient
|
|
Correlation Coefficient Between Plasma PD 0332991 Concentration and Change From Baseline in Biomarkers and SUVmax at Cycle 1 Day 21
Concentration versus phospho-Rb (n= 10)
|
-0.55533 correlation coefficient
|
|
Correlation Coefficient Between Plasma PD 0332991 Concentration and Change From Baseline in Biomarkers and SUVmax at Cycle 1 Day 21
Concentration versus FLT-PET SUVmax (n= 16)
|
0.28767 correlation coefficient
|
|
Correlation Coefficient Between Plasma PD 0332991 Concentration and Change From Baseline in Biomarkers and SUVmax at Cycle 1 Day 21
Concentration versus FDG-PET SUVmax (n= 16)
|
-0.18526 correlation coefficient
|
Adverse Events
PD 0332991
Serious adverse events
| Measure |
PD 0332991
n=17 participants at risk
PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion.
|
|---|---|
|
Cardiac disorders
Cardiac arrest
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
PD 0332991
n=17 participants at risk
PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator's discretion.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
17.6%
3/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Leukopenia
|
17.6%
3/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Macrocytosis
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
47.1%
8/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
35.3%
6/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Palpitations
|
11.8%
2/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Ear and labyrinth disorders
Ear pain
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Conjunctival haemorrhage
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Lacrimation increased
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Ocular hyperaemia
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Vision blurred
|
11.8%
2/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Visual impairment
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
11.8%
2/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
17.6%
3/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
23.5%
4/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dry mouth
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
17.6%
3/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Haematochezia
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
17.6%
3/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Oral pain
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Axillary pain
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chest pain
|
11.8%
2/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chills
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Fatigue
|
35.3%
6/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Influenza like illness
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Infusion site extravasation
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Oedema peripheral
|
17.6%
3/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
11.8%
2/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Thirst
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Balanitis candida
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Cellulitis
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Proctitis monilial
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Tooth abscess
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
17.6%
3/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood creatinine increased
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Liver function test abnormal
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.8%
2/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
11.8%
2/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
11.8%
2/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
11.8%
2/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.8%
2/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Balance disorder
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Brachial plexopathy
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
17.6%
3/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dysgeusia
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
17.6%
3/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Hypogeusia
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Neuropathy peripheral
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Anxiety
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Depression
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Insomnia
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Nocturia
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Pollakiuria
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Breast pain
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Scrotal pain
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.8%
2/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.8%
2/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.8%
2/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Blister
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
17.6%
3/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.8%
2/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
35.3%
6/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hot flush
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypotension
|
17.6%
3/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Oedema
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Eye infection
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Laryngitis
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood phosphorus decreased
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Hypoaesthesia
|
5.9%
1/17
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER