Trial Outcomes & Findings for A Study to Describe the Breast Cancer Patient Population, Treatment, and Results in Indian Patients Receiving Combinations of the Medicines Called Palbociclib for Advanced Breast Cancer (NCT NCT05584644)
NCT ID: NCT05584644
Last Updated: 2023-12-19
Results Overview
Number of participants according to their starting dose (125 milligrams per day \[mg/day\], 100 mg/day) of palbociclib were reported in this outcome measure. For participants whose dose details were not available was reported under 'data not available'. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
COMPLETED
150 participants
From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
2023-12-19
Participant Flow
Data of participants diagnosed with hormone receptor positive (HR+) /human epidermal growth factor receptor 2 negative (HER2-) advanced/metastatic breast cancer (ABC/MBC), who received palbociclib combined with aromatase inhibitor in menopausal state as initial endocrine therapy in MBC or with fulvestrant after progression on prior endocrine therapy were observed.
This retrospective observational study used medical records of participants from 6 oncology hospitals within a period of Dec 2016 to May 2021 (approximately 4.5 years). Available data was evaluated in 9 months of this retrospective observational study.
Participant milestones
| Measure |
Palbociclib: 1st Line Therapy
Participants who received palbociclib in combination with hormonal therapy as first line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
Palbociclib: 2nd Line Therapy
Participants who received palbociclib in combination with hormonal therapy as second line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
|---|---|---|
|
Overall Study
STARTED
|
105
|
45
|
|
Overall Study
COMPLETED
|
105
|
45
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Palbociclib: 1st Line Therapy
n=105 Participants
Participants who received palbociclib in combination with hormonal therapy as first line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
Palbociclib: 2nd Line Therapy
n=45 Participants
Participants who received palbociclib in combination with hormonal therapy as second line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Less than or equal to (<=) 65 years
|
66 Participants
n=105 Participants
|
32 Participants
n=45 Participants
|
98 Participants
n=150 Participants
|
|
Age, Customized
Greater than (>) 65 years
|
39 Participants
n=105 Participants
|
13 Participants
n=45 Participants
|
52 Participants
n=150 Participants
|
|
Sex: Female, Male
Female
|
105 Participants
n=105 Participants
|
45 Participants
n=45 Participants
|
150 Participants
n=150 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=105 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=150 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
Number of participants according to their starting dose (125 milligrams per day \[mg/day\], 100 mg/day) of palbociclib were reported in this outcome measure. For participants whose dose details were not available was reported under 'data not available'. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Outcome measures
| Measure |
Palbociclib: 1st Line Therapy
n=105 Participants
Participants who received palbociclib in combination with hormonal therapy as first line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
Palbociclib: 2nd Line Therapy
n=45 Participants
Participants who received palbociclib in combination with hormonal therapy as second line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
|---|---|---|
|
Number of Participants According to the Starting Dose of Palbociclib
Data not available
|
5 Participants
|
0 Participants
|
|
Number of Participants According to the Starting Dose of Palbociclib
125mg/day
|
99 Participants
|
43 Participants
|
|
Number of Participants According to the Starting Dose of Palbociclib
100mg/day
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From index date to end of treatment, from Dec 2016 to May 2021 (approximately 4.5 years); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
Duration of treatment was reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Outcome measures
| Measure |
Palbociclib: 1st Line Therapy
n=105 Participants
Participants who received palbociclib in combination with hormonal therapy as first line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
Palbociclib: 2nd Line Therapy
n=45 Participants
Participants who received palbociclib in combination with hormonal therapy as second line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
|---|---|---|
|
Duration of Treatment
|
15.08 Months
Interval 9.67 to 22.43
|
11.63 Months
Interval 6.37 to 19.6
|
PRIMARY outcome
Timeframe: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
Number of participants according to dose reductions during palbociclib treatment were reported in this outcome measure. Dose was reduced to 100mg and 75 mg. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Outcome measures
| Measure |
Palbociclib: 1st Line Therapy
n=105 Participants
Participants who received palbociclib in combination with hormonal therapy as first line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
Palbociclib: 2nd Line Therapy
n=45 Participants
Participants who received palbociclib in combination with hormonal therapy as second line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
|---|---|---|
|
Number of Participants Who Had Any Palbociclib Dose Reduction
Dose reduced to 100 mg
|
13 Participants
|
1 Participants
|
|
Number of Participants Who Had Any Palbociclib Dose Reduction
Dose reduced to 75 mg
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
Number of participants with any interruptions during palbociclib treatment were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Outcome measures
| Measure |
Palbociclib: 1st Line Therapy
n=105 Participants
Participants who received palbociclib in combination with hormonal therapy as first line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
Palbociclib: 2nd Line Therapy
n=45 Participants
Participants who received palbociclib in combination with hormonal therapy as second line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
|---|---|---|
|
Number of Participants Who Had Any Interruption in Palbociclib Treatment
|
9 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
Number of participants who had any delay in palbociclib treatment were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Outcome measures
| Measure |
Palbociclib: 1st Line Therapy
n=105 Participants
Participants who received palbociclib in combination with hormonal therapy as first line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
Palbociclib: 2nd Line Therapy
n=45 Participants
Participants who received palbociclib in combination with hormonal therapy as second line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
|---|---|---|
|
Number of Participants Who Had Any Delays in Palbociclib Treatment
|
7 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
Number of participants classified according to reasons for treatment discontinuations which included increased transaminases, cardiomyopathy was reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Outcome measures
| Measure |
Palbociclib: 1st Line Therapy
n=105 Participants
Participants who received palbociclib in combination with hormonal therapy as first line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
Palbociclib: 2nd Line Therapy
n=45 Participants
Participants who received palbociclib in combination with hormonal therapy as second line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
|---|---|---|
|
Number of Participants According to Reasons for Treatment Discontinuation
Increased transaminases
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Reasons for Treatment Discontinuation
Cardiomyopathy
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Number of participants classified according to reasons for change in treatment were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Outcome measures
| Measure |
Palbociclib: 1st Line Therapy
n=18 Participants
Participants who received palbociclib in combination with hormonal therapy as first line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
Palbociclib: 2nd Line Therapy
n=18 Participants
Participants who received palbociclib in combination with hormonal therapy as second line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
|---|---|---|
|
Number of Participants According to Reasons for Change in Treatment
Dose Resumed following interruption or cycle delay
|
9 Participants
|
3 Participants
|
|
Number of Participants According to Reasons for Change in Treatment
Side effects/toxicity
|
10 Participants
|
3 Participants
|
|
Number of Participants According to Reasons for Change in Treatment
Other reasons
|
5 Participants
|
0 Participants
|
|
Number of Participants According to Reasons for Change in Treatment
Dose Reduced
|
12 Participants
|
4 Participants
|
|
Number of Participants According to Reasons for Change in Treatment
Dose Interrupted (temporarily stopped during a dose cycle)
|
9 Participants
|
1 Participants
|
|
Number of Participants According to Reasons for Change in Treatment
Cycle delay (the next cycle is pushed back)
|
7 Participants
|
1 Participants
|
|
Number of Participants According to Reasons for Change in Treatment
Combination partner therapy continued
|
17 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: From index date to death or disease progression start of new therapy or last available follow-up whichever occurred first,maximum up to approximately 4.5years;available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Progression free survival was defined as the time from palbociclib combination treatment initiation until 1) clinician documented disease progression (PD) while on palbociclib, 2) death, 3) start of a new therapy line after final palbociclib dose, if the reason for discontinuation of palbociclib was disease progression, or 4) last available follow-up, whichever occurred first. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Outcome measures
| Measure |
Palbociclib: 1st Line Therapy
n=77 Participants
Participants who received palbociclib in combination with hormonal therapy as first line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
Palbociclib: 2nd Line Therapy
n=28 Participants
Participants who received palbociclib in combination with hormonal therapy as second line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
|---|---|---|
|
Progression Free Survival
|
31.97 Months
Interval 22.43 to 47.5
|
22.33 Months
Interval 11.8 to 48.8
|
PRIMARY outcome
Timeframe: From index date to CR/PR, from Dec 2016 to May 2021 (approximately 4.5 years); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
The objective response rate was defined as the percentage of participants with complete response (CR) and partial response (PR). As per RECIST version 1.1 criteria: CR = disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm). Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis); PR = at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Outcome measures
| Measure |
Palbociclib: 1st Line Therapy
n=105 Participants
Participants who received palbociclib in combination with hormonal therapy as first line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
Palbociclib: 2nd Line Therapy
n=45 Participants
Participants who received palbociclib in combination with hormonal therapy as second line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
|---|---|---|
|
Objective Response Rate (ORR)
|
63.81 Percentage of participants
|
77.78 Percentage of participants
|
PRIMARY outcome
Timeframe: From index date to death, from Dec 2016 to May 2021 (approximately 4.5 years); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
Number of participants who died were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Outcome measures
| Measure |
Palbociclib: 1st Line Therapy
n=105 Participants
Participants who received palbociclib in combination with hormonal therapy as first line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
Palbociclib: 2nd Line Therapy
n=45 Participants
Participants who received palbociclib in combination with hormonal therapy as second line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
|---|---|---|
|
Number of Participants Who Died
|
8 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: From index date to death due to any cause, (from Dec 2016 to May 2021 [approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
OS was defined as the time from index date to the date of death due to any cause. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Outcome measures
| Measure |
Palbociclib: 1st Line Therapy
n=105 Participants
Participants who received palbociclib in combination with hormonal therapy as first line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
Palbociclib: 2nd Line Therapy
n=45 Participants
Participants who received palbociclib in combination with hormonal therapy as second line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
|---|---|---|
|
Overall Survival (OS)
|
NA Months
Median and 95%CI could not be calculated as there were less number of participants with event.
|
NA Months
Median and 95%CI could not be calculated as there were less number of participants with event.
|
PRIMARY outcome
Timeframe: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
Number of participants classified according to the biomarker status were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Outcome measures
| Measure |
Palbociclib: 1st Line Therapy
n=105 Participants
Participants who received palbociclib in combination with hormonal therapy as first line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
Palbociclib: 2nd Line Therapy
n=45 Participants
Participants who received palbociclib in combination with hormonal therapy as second line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
|---|---|---|
|
Number of Participants According to Biomarker Status
|
NA Participants
The data of eligible participants were not available on medical records.
|
NA Participants
The data of eligible participants were not available on medical records.
|
PRIMARY outcome
Timeframe: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
Number of participants with family history of breast cancer were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Outcome measures
| Measure |
Palbociclib: 1st Line Therapy
n=105 Participants
Participants who received palbociclib in combination with hormonal therapy as first line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
Palbociclib: 2nd Line Therapy
n=45 Participants
Participants who received palbociclib in combination with hormonal therapy as second line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
|---|---|---|
|
Number of Participants With Family History of Breast Cancer
|
4 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
Duration from breast cancer diagnosis to palbociclib treatment was reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Outcome measures
| Measure |
Palbociclib: 1st Line Therapy
n=105 Participants
Participants who received palbociclib in combination with hormonal therapy as first line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
Palbociclib: 2nd Line Therapy
n=45 Participants
Participants who received palbociclib in combination with hormonal therapy as second line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
|---|---|---|
|
Duration From Breast Cancer Diagnosis to Palbociclib Treatment
|
8.69 Months
Standard Deviation 26.12
|
45.50 Months
Standard Deviation 43.53
|
PRIMARY outcome
Timeframe: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
Number of participants classified according to stages (Stage I, II, IIIa, IV) of breast cancer were included in this outcome measure. Stage I indicated the cancer was small and had not spread anywhere else, Stage II indicated the cancer had grown, but had not spread, Stage IIIa indicated the cancer had grown larger and might have spread to the surrounding tissues and/or the lymph nodes. Stage IV indicated the cancer had spread from where it started to at least 1 other body organ, also known as secondary or metastatic cancer. For participants whose breast cancer stage were not available was reported under 'data not available'. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Outcome measures
| Measure |
Palbociclib: 1st Line Therapy
n=105 Participants
Participants who received palbociclib in combination with hormonal therapy as first line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
Palbociclib: 2nd Line Therapy
n=45 Participants
Participants who received palbociclib in combination with hormonal therapy as second line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
|---|---|---|
|
Number of Participants According to Stages of Breast Cancer
Stage IIIa
|
1 Participants
|
1 Participants
|
|
Number of Participants According to Stages of Breast Cancer
Data not available
|
24 Participants
|
1 Participants
|
|
Number of Participants According to Stages of Breast Cancer
Stage I
|
5 Participants
|
0 Participants
|
|
Number of Participants According to Stages of Breast Cancer
Stage II
|
5 Participants
|
12 Participants
|
|
Number of Participants According to Stages of Breast Cancer
Stage IV
|
70 Participants
|
31 Participants
|
PRIMARY outcome
Timeframe: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
Number of participants classified according to node status were included in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Outcome measures
| Measure |
Palbociclib: 1st Line Therapy
n=105 Participants
Participants who received palbociclib in combination with hormonal therapy as first line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
Palbociclib: 2nd Line Therapy
n=45 Participants
Participants who received palbociclib in combination with hormonal therapy as second line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
|---|---|---|
|
Number of Participants According to Node Status
Regional nodes
|
5 Participants
|
5 Participants
|
|
Number of Participants According to Node Status
Distal
|
6 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
Number of participants classified according to menopausal status which included natural and induced were included in this outcome measure. For participants whose details were not available was reported under 'data not available'. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Outcome measures
| Measure |
Palbociclib: 1st Line Therapy
n=105 Participants
Participants who received palbociclib in combination with hormonal therapy as first line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
Palbociclib: 2nd Line Therapy
n=45 Participants
Participants who received palbociclib in combination with hormonal therapy as second line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
|---|---|---|
|
Number of Participants According to Menopausal Status
Induced
|
16 Participants
|
16 Participants
|
|
Number of Participants According to Menopausal Status
Natural
|
88 Participants
|
29 Participants
|
|
Number of Participants According to Menopausal Status
Data not available
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
ECOG PS was used to assess physical health of participants. ECOG PS grade:0= fully active, able to carry on all pre-disease performance without restriction,1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature 2= ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours, 3= capable of only limited self-care, 4= completely disabled, cannot carry on any selfcare totally confined to bed or chair confined to bed or chair more than 50% of waking hours and 5= dead. Participants whose ECOG scores were not available reported as 'data not available'. Only those categories with non-zero values were reported. Index date= 60 days after physician first prescribed palbociclib + hormonal following availability of specific indication in market.
Outcome measures
| Measure |
Palbociclib: 1st Line Therapy
n=105 Participants
Participants who received palbociclib in combination with hormonal therapy as first line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
Palbociclib: 2nd Line Therapy
n=45 Participants
Participants who received palbociclib in combination with hormonal therapy as second line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
|---|---|---|
|
Number of Participants According to Performance Status Based on Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
1
|
65 Participants
|
33 Participants
|
|
Number of Participants According to Performance Status Based on Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
2
|
6 Participants
|
5 Participants
|
|
Number of Participants According to Performance Status Based on Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
3
|
0 Participants
|
1 Participants
|
|
Number of Participants According to Performance Status Based on Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Data not available
|
34 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
Number of participants classified according to metastatic sites were reported in this outcome measure. Metastatic sites included bone, lung, liver, lymph nodes, others. For participants whose details were not available was reported under 'data not available'. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market. Participant could have more than 1 location of metastases.
Outcome measures
| Measure |
Palbociclib: 1st Line Therapy
n=105 Participants
Participants who received palbociclib in combination with hormonal therapy as first line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
Palbociclib: 2nd Line Therapy
n=45 Participants
Participants who received palbociclib in combination with hormonal therapy as second line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
|---|---|---|
|
Number of Participants According to Metastatic Sites
Bone
|
62 Participants
|
28 Participants
|
|
Number of Participants According to Metastatic Sites
Lung
|
28 Participants
|
16 Participants
|
|
Number of Participants According to Metastatic Sites
Liver
|
14 Participants
|
7 Participants
|
|
Number of Participants According to Metastatic Sites
Lymph nodes
|
16 Participants
|
6 Participants
|
|
Number of Participants According to Metastatic Sites
Others
|
7 Participants
|
4 Participants
|
|
Number of Participants According to Metastatic Sites
Data not available
|
12 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
Participants classified according to status of disease as de novo versus and recurrent disease were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Outcome measures
| Measure |
Palbociclib: 1st Line Therapy
n=105 Participants
Participants who received palbociclib in combination with hormonal therapy as first line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
Palbociclib: 2nd Line Therapy
n=45 Participants
Participants who received palbociclib in combination with hormonal therapy as second line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
|---|---|---|
|
Number of Participants According to de Novo and Recurrent Disease
|
NA Participants
The data of eligible participants were not available on medical records.
|
NA Participants
The data of eligible participants were not available on medical records.
|
PRIMARY outcome
Timeframe: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
Participants classified according to therapies received for early breast cancer which included adjuvant chemotherapy, adjuvant endocrine therapy, neoadjuvant treatment, radiotherapy, surgery were reported in this outcome measure. For participants whose details were not available was reported under 'data not available'. Participant could have received more than 1 therapy. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Outcome measures
| Measure |
Palbociclib: 1st Line Therapy
n=105 Participants
Participants who received palbociclib in combination with hormonal therapy as first line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
Palbociclib: 2nd Line Therapy
n=45 Participants
Participants who received palbociclib in combination with hormonal therapy as second line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
|---|---|---|
|
Number of Participants According to Therapies Received for Early Breast Cancer
Adjuvant chemotherapy
|
4 Participants
|
8 Participants
|
|
Number of Participants According to Therapies Received for Early Breast Cancer
Adjuvant endocrine therapy
|
14 Participants
|
5 Participants
|
|
Number of Participants According to Therapies Received for Early Breast Cancer
Neoadjuvant treatment
|
6 Participants
|
11 Participants
|
|
Number of Participants According to Therapies Received for Early Breast Cancer
Radiotherapy
|
20 Participants
|
26 Participants
|
|
Number of Participants According to Therapies Received for Early Breast Cancer
Surgery
|
13 Participants
|
26 Participants
|
|
Number of Participants According to Therapies Received for Early Breast Cancer
Data not available
|
69 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Outcome measures
| Measure |
Palbociclib: 1st Line Therapy
n=105 Participants
Participants who received palbociclib in combination with hormonal therapy as first line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
Palbociclib: 2nd Line Therapy
n=45 Participants
Participants who received palbociclib in combination with hormonal therapy as second line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
|---|---|---|
|
Time Since End of Adjuvant Treatment
|
NA Months
The data of eligible participants were not available on medical records.
|
NA Months
The data of eligible participants were not available on medical records.
|
PRIMARY outcome
Timeframe: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
Participants were classified according to supportive therapies received for HR+/HER2- diagnosis and were reported in this outcome measure. Supportive therapies included nutritional treatment, bisphosphonates, anti-anxiety, anti-depressant, anti-emetics, non-steroidal anti-inflammatory drugs. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Outcome measures
| Measure |
Palbociclib: 1st Line Therapy
n=105 Participants
Participants who received palbociclib in combination with hormonal therapy as first line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
Palbociclib: 2nd Line Therapy
n=45 Participants
Participants who received palbociclib in combination with hormonal therapy as second line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
|---|---|---|
|
Number of Participants According to Supportive Therapies Received for Hormone Receptor Positive / Human Epidermal Growth Factor 2 Negative (HR+/HER2-) Diagnosis
Nutritional support
|
37 Participants
|
7 Participants
|
|
Number of Participants According to Supportive Therapies Received for Hormone Receptor Positive / Human Epidermal Growth Factor 2 Negative (HR+/HER2-) Diagnosis
Bisphosphonates
|
8 Participants
|
2 Participants
|
|
Number of Participants According to Supportive Therapies Received for Hormone Receptor Positive / Human Epidermal Growth Factor 2 Negative (HR+/HER2-) Diagnosis
Antibiotics
|
5 Participants
|
1 Participants
|
|
Number of Participants According to Supportive Therapies Received for Hormone Receptor Positive / Human Epidermal Growth Factor 2 Negative (HR+/HER2-) Diagnosis
Anti-anxiety
|
3 Participants
|
0 Participants
|
|
Number of Participants According to Supportive Therapies Received for Hormone Receptor Positive / Human Epidermal Growth Factor 2 Negative (HR+/HER2-) Diagnosis
Anti-depressants
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Supportive Therapies Received for Hormone Receptor Positive / Human Epidermal Growth Factor 2 Negative (HR+/HER2-) Diagnosis
Anti-emetics
|
1 Participants
|
1 Participants
|
|
Number of Participants According to Supportive Therapies Received for Hormone Receptor Positive / Human Epidermal Growth Factor 2 Negative (HR+/HER2-) Diagnosis
Opioid extended release
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Supportive Therapies Received for Hormone Receptor Positive / Human Epidermal Growth Factor 2 Negative (HR+/HER2-) Diagnosis
Opioid immediate release
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Supportive Therapies Received for Hormone Receptor Positive / Human Epidermal Growth Factor 2 Negative (HR+/HER2-) Diagnosis
Non-steroidal anti-inflammatory drugs
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Supportive Therapies Received for Hormone Receptor Positive / Human Epidermal Growth Factor 2 Negative (HR+/HER2-) Diagnosis
Other supportive care
|
36 Participants
|
3 Participants
|
|
Number of Participants According to Supportive Therapies Received for Hormone Receptor Positive / Human Epidermal Growth Factor 2 Negative (HR+/HER2-) Diagnosis
NA
|
50 Participants
|
36 Participants
|
PRIMARY outcome
Timeframe: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Outcome measures
| Measure |
Palbociclib: 1st Line Therapy
n=105 Participants
Participants who received palbociclib in combination with hormonal therapy as first line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
Palbociclib: 2nd Line Therapy
n=45 Participants
Participants who received palbociclib in combination with hormonal therapy as second line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
|---|---|---|
|
Duration of Supportive Treatments for ABC/MBC
|
NA Months
The data of eligible participants were not available on medical records.
|
NA Months
The data of eligible participants were not available on medical records.
|
PRIMARY outcome
Timeframe: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
Participants were classified according to reasons for regimen change and were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Outcome measures
| Measure |
Palbociclib: 1st Line Therapy
n=105 Participants
Participants who received palbociclib in combination with hormonal therapy as first line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
Palbociclib: 2nd Line Therapy
n=45 Participants
Participants who received palbociclib in combination with hormonal therapy as second line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
|---|---|---|
|
Number of Participants According to Reasons for Regimen Change
|
NA Participants
The data of eligible participants were not available on medical records.
|
NA Participants
The data of eligible participants were not available on medical records.
|
Adverse Events
Palbociclib: 1st Line Therapy
Palbociclib: 2nd Line Therapy
Serious adverse events
| Measure |
Palbociclib: 1st Line Therapy
n=105 participants at risk
Participants who received palbociclib in combination with hormonal therapy as first line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
Palbociclib: 2nd Line Therapy
n=45 participants at risk
Participants who received palbociclib in combination with hormonal therapy as second line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
1.9%
2/105 • From index date until end of follow up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From index date until end of follow up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Cardiomyopathy
|
0.95%
1/105 • From index date until end of follow up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From index date until end of follow up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Embolism
|
0.95%
1/105 • From index date until end of follow up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From index date until end of follow up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
Other adverse events
| Measure |
Palbociclib: 1st Line Therapy
n=105 participants at risk
Participants who received palbociclib in combination with hormonal therapy as first line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
Palbociclib: 2nd Line Therapy
n=45 participants at risk
Participants who received palbociclib in combination with hormonal therapy as second line therapy under standard real world practice for HR+/HER2- MBC were included in this retrospective observational study. Available data were evaluated in 9 months of this study.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.95%
1/105 • From index date until end of follow up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From index date until end of follow up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Increased Transaminases
|
0.95%
1/105 • From index date until end of follow up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/45 • From index date until end of follow up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
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