Trial Outcomes & Findings for A Study of Ipatasertib (GDC-0068) in Combination With Paclitaxel as Neoadjuvant Treatment for Participants With Early Stage Triple Negative Breast Cancer (NCT NCT02301988)

NCT ID: NCT02301988

Last Updated: 2018-10-17

Results Overview

pCR was defined by ypT0/Tis ypN0 in the American Joint Committee on Cancer (AJCC) Staging System with the following determination for breast and axilla by local pathology laboratory evaluation: T0: no evidence of primary tumor; Tis: early cancer that has not spread to neighboring tissue and N0: no cancer found in the lymph nodes.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

151 participants

Primary outcome timeframe

Surgery visit (at approximately Weeks 14 to 19)

Results posted on

2018-10-17

Participant Flow

Participant milestones

Participant milestones
Measure	Ipatasertib + Paclitaxel Participants received ipatasertib orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel intravenous (IV) infusion every week (QW) for 3 cycles (12 total doses).	Placebo + Paclitaxel Participants received placebo (matching to ipatasertib) orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel IV infusion QW for 3 cycles (12 total doses).
Overall Study STARTED	76	75
Overall Study COMPLETED	66	66
Overall Study NOT COMPLETED	10	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Ipatasertib + Paclitaxel Participants received ipatasertib orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel intravenous (IV) infusion every week (QW) for 3 cycles (12 total doses).	Placebo + Paclitaxel Participants received placebo (matching to ipatasertib) orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel IV infusion QW for 3 cycles (12 total doses).
Overall Study Withdrawal by Subject	2	1
Overall Study Physician Decision	2	2
Overall Study Unknown Reason	1	3
Overall Study Lack of Efficacy	3	2
Overall Study Death	1	0
Overall Study Adverse Event	1	1

Baseline Characteristics

A Study of Ipatasertib (GDC-0068) in Combination With Paclitaxel as Neoadjuvant Treatment for Participants With Early Stage Triple Negative Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ipatasertib + Paclitaxel n=76 Participants Participants received ipatasertib orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel intravenous (IV) infusion every week (QW) for 3 cycles (12 total doses).	Placebo + Paclitaxel n=75 Participants Participants received placebo (matching to ipatasertib) orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel IV infusion QW for 3 cycles (12 total doses).	Total n=151 Participants Total of all reporting groups
Age, Continuous	53.8 years STANDARD_DEVIATION 10.9 • n=5 Participants	53.8 years STANDARD_DEVIATION 12.0 • n=7 Participants	53.8 years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	76 Participants n=5 Participants	75 Participants n=7 Participants	151 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	71 Participants n=5 Participants	70 Participants n=7 Participants	141 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Surgery visit (at approximately Weeks 14 to 19)

Population: The ITT population included all randomized participants.

Outcome measures

Outcome measures
Measure	Ipatasertib + Paclitaxel n=76 Participants Participants received ipatasertib orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel intravenous (IV) infusion every week (QW) for 3 cycles (12 total doses).	Placebo + Paclitaxel n=75 Participants Participants received placebo (matching to ipatasertib) orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel IV infusion QW for 3 cycles (12 total doses).
Percentage of Participants With Pathological Complete Response (pCR) in Breast and Axilla as Defined by ypT0/Tis ypN0 in the American Joint Committee on Cancer Staging System (in All Participants)	17.1 percentage of participants Interval 9.82 to 27.25	13.3 percentage of participants Interval 6.58 to 22.86

PRIMARY outcome

Timeframe: Surgery visit (at approximately Weeks 14 to 19)

Population: The ITT population included all randomized participants who have PTEN-low tumors.

pCR was defined by ypT0/Tis ypN0 in the AJCC Staging System with the following determination for breast and axilla by local pathology laboratory evaluation: T0: no evidence of primary tumor; Tis: early cancer that has not spread to neighboring tissue and N0: no cancer found in the lymph nodes.

Outcome measures

Outcome measures
Measure	Ipatasertib + Paclitaxel n=19 Participants Participants received ipatasertib orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel intravenous (IV) infusion every week (QW) for 3 cycles (12 total doses).	Placebo + Paclitaxel n=16 Participants Participants received placebo (matching to ipatasertib) orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel IV infusion QW for 3 cycles (12 total doses).
Percentage of Participants With pCR in Breast and Axilla as Defined by ypT0/Tis ypN0 in the American Joint Committee on Cancer Staging System (in Participants Who Have Phosphatase and Tensin Homolog [PTEN]-Low Tumors)	15.8 percentage of participants Interval 4.45 to 38.36	12.5 percentage of participants Interval 2.27 to 35.43

SECONDARY outcome

Timeframe: Surgery visit (at approximately Weeks 14 to 19)

Population: The ITT population included all randomized participants.

pCR was defined by ypT0/Tis in the AJCC Staging System with the following determination for breast by local pathology laboratory evaluation: T0: no evidence of primary tumor; Tis: early cancer that has not spread to neighboring tissue.

Outcome measures

Outcome measures
Measure	Ipatasertib + Paclitaxel n=76 Participants Participants received ipatasertib orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel intravenous (IV) infusion every week (QW) for 3 cycles (12 total doses).	Placebo + Paclitaxel n=75 Participants Participants received placebo (matching to ipatasertib) orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel IV infusion QW for 3 cycles (12 total doses).
Percentage of Participants With pCR in Breast as Defined by ypT0/Tis in the American Joint Committee on Cancer Staging System (in All Participants)	22.4 percentage of participants Interval 14.33 to 33.31	14.7 percentage of participants Interval 7.98 to 24.04

SECONDARY outcome

Timeframe: Surgery visit (at approximately Weeks 14 to 19)

Population: The ITT population included all randomized participants who have PTEN-low tumors.

Outcome measures

Outcome measures
Measure	Ipatasertib + Paclitaxel n=19 Participants Participants received ipatasertib orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel intravenous (IV) infusion every week (QW) for 3 cycles (12 total doses).	Placebo + Paclitaxel n=16 Participants Participants received placebo (matching to ipatasertib) orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel IV infusion QW for 3 cycles (12 total doses).
Percentage of Participants With pCR in Breast as Defined by ypT0/Tis in the American Joint Committee on Cancer Staging System (in Participants Who Have PTEN-low Tumors)	15.8 percentage of participants Interval 4.45 to 38.36	18.8 percentage of participants Interval 5.31 to 42.94

SECONDARY outcome

Timeframe: Screening up to disease progression or death (assessed at screening, pre-surgical visit [approximately Weeks 10-12], early termination visit [up to Week 16])

Population: The ITT population included all randomized participants.

Objective tumor response (OR) was based on criteria related to changes in size of target lesions according to modified RECIST. Target lesions were selected on the basis of their size (lesions with the longest diameter) as well as the feasibility of reproducible repeated measurements. OR was the sum of complete response (CR) and partial response (PR). CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Outcome measures
Measure	Ipatasertib + Paclitaxel n=76 Participants Participants received ipatasertib orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel intravenous (IV) infusion every week (QW) for 3 cycles (12 total doses).	Placebo + Paclitaxel n=75 Participants Participants received placebo (matching to ipatasertib) orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel IV infusion QW for 3 cycles (12 total doses).
Percentage of Participants With Objective Tumor Response by Magnetic Resonance Imaging (MRI), As Assessed by Investigator Per the Modified Response Evaluation Criteria in Solid Tumors (RECIST) (in All Participants)	67.1 percentage of participants Interval 55.86 to 77.46	56.0 percentage of participants Interval 44.46 to 66.84

SECONDARY outcome

Timeframe: Screening up to disease progression or death (assessed at screening, pre-surgical visit [approximately Weeks 10-12], early termination visit [up to Week 16])

Population: The ITT population included all randomized participants who have PTEN-low tumors.

ORR was based on criteria related to changes in size of target lesions according to modified RECIST. Target lesions were selected on the basis of their size (lesions with the longest diameter) as well as the feasibility of reproducible repeated measurements. ORR was the sum of complete response (CR) and partial response (PR). CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Outcome measures
Measure	Ipatasertib + Paclitaxel n=19 Participants Participants received ipatasertib orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel intravenous (IV) infusion every week (QW) for 3 cycles (12 total doses).	Placebo + Paclitaxel n=16 Participants Participants received placebo (matching to ipatasertib) orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel IV infusion QW for 3 cycles (12 total doses).
Percentage of Participants With Objective Tumor Response by MRI, As Assessed by Investigator Per Modified RECIST (in Participants Who Have PTEN-low Tumors)	73.7 percentage of participants Interval 50.0 to 89.01	50.0 percentage of participants Interval 27.2 to 72.8

SECONDARY outcome

Timeframe: Surgery visit (at approximately Weeks 14 to 19)

Population: The ITT population included all randomized participants who are Akt Dx+.

Outcome measures

Outcome measures
Measure	Ipatasertib + Paclitaxel n=28 Participants Participants received ipatasertib orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel intravenous (IV) infusion every week (QW) for 3 cycles (12 total doses).	Placebo + Paclitaxel n=34 Participants Participants received placebo (matching to ipatasertib) orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel IV infusion QW for 3 cycles (12 total doses).
Percentage of Participants With pCR in Breast and Axilla as Defined by ypT0/Tis ypN0 in the American Joint Committee on Cancer Staging System (in Participants Who Are Akt Diagnostic Positive [Dx+])	17.9 percentage of participants Interval 7.31 to 35.71	11.8 percentage of participants Interval 4.12 to 27.19

SECONDARY outcome

Timeframe: Surgery visit (at approximately Weeks 14 to 19)

Population: The ITT population included all randomized participants who are Akt Dx+.

Outcome measures

Outcome measures
Measure	Ipatasertib + Paclitaxel n=28 Participants Participants received ipatasertib orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel intravenous (IV) infusion every week (QW) for 3 cycles (12 total doses).	Placebo + Paclitaxel n=34 Participants Participants received placebo (matching to ipatasertib) orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel IV infusion QW for 3 cycles (12 total doses).
Percentage of Participants With pCR in Breast as Defined by ypT0/Tis in the American Joint Committee on Cancer Staging System (in Participants Who Are Akt Dx+)	21.4 percentage of participants Interval 9.77 to 40.58	11.8 percentage of participants Interval 4.12 to 27.19

SECONDARY outcome

Timeframe: Surgery visit (at approximately Weeks 14 to 19)

Population: The ITT population included all randomized participants.

pCR was defined by ypT0/Tis in the AJCC Staging System with the following determination for breast subtypes by local pathology laboratory evaluation: T0: no evidence of primary tumor; Tis: early cancer that has not spread to neighboring tissue. The intrinsic molecular subtypes of breast cancer included here are luminal A (LumA), Her-2, basal-like, normal and unknown.

Outcome measures

Outcome measures
Measure	Ipatasertib + Paclitaxel n=76 Participants Participants received ipatasertib orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel intravenous (IV) infusion every week (QW) for 3 cycles (12 total doses).	Placebo + Paclitaxel n=75 Participants Participants received placebo (matching to ipatasertib) orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel IV infusion QW for 3 cycles (12 total doses).
Percentage of Participants With pCR According to American Joint Committee on Cancer Staging System, by Breast Cancer Subtype Unknown	18.5 percentage of participants	21.9 percentage of participants
Percentage of Participants With pCR According to American Joint Committee on Cancer Staging System, by Breast Cancer Subtype Basal	22.0 percentage of participants	10.8 percentage of participants
Percentage of Participants With pCR According to American Joint Committee on Cancer Staging System, by Breast Cancer Subtype Her2	33.3 percentage of participants	0 percentage of participants
Percentage of Participants With pCR According to American Joint Committee on Cancer Staging System, by Breast Cancer Subtype LumA	—	0 percentage of participants
Percentage of Participants With pCR According to American Joint Committee on Cancer Staging System, by Breast Cancer Subtype Normal	50.0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Surgery visit (at approximately Weeks 14 to 19)

Population: The ITT population included all randomized participants with T2 or T3 Tumors.

After neoadjuvant treatment, the number of patients who is appropriate for breast conserving surgery is reported as a measure of efficacy of the treatment to shrink the tumor enough for patients to benefit from less aggressive surgical management. Breast-conserving surgery was defined as removal of part of the breast tissue during surgery. T2 or T3 in the AJCC Staging System were defined as follows: T2: tumor was more than 2 centimeter (cm) but no more than 5 cm across; T3: tumor was larger than 5 cm across.

Outcome measures

Outcome measures
Measure	Ipatasertib + Paclitaxel n=62 Participants Participants received ipatasertib orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel intravenous (IV) infusion every week (QW) for 3 cycles (12 total doses).	Placebo + Paclitaxel n=63 Participants Participants received placebo (matching to ipatasertib) orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel IV infusion QW for 3 cycles (12 total doses).
Percentage of Participants With Response to Undergoing Breast Conserving Surgery (BCS) Among Participants With T2 or T3 Tumors	64.5 percentage of participants Interval 51.93 to 76.26	60.3 percentage of participants Interval 47.2 to 71.74

SECONDARY outcome

Timeframe: From screening to surgery visit (at approximately Weeks 14 to 19)

Population: The ITT population included all randomized participants with T2 or T3 Tumors with response to conversion to BCS.

Outcome measures

Outcome measures
Measure	Ipatasertib + Paclitaxel n=12 Participants Participants received ipatasertib orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel intravenous (IV) infusion every week (QW) for 3 cycles (12 total doses).	Placebo + Paclitaxel n=16 Participants Participants received placebo (matching to ipatasertib) orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel IV infusion QW for 3 cycles (12 total doses).
Percentage of Participants With Response to Conversion to BCS Among Participants With T2 or T3 Tumors	33.3 percentage of participants Interval 12.29 to 65.11	25 percentage of participants Interval 9.03 to 50.0

SECONDARY outcome

Timeframe: Screening up to Week 24

Population: The safety population was identical to the ITT population and included all randomized participants.

An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

Outcome measures

Outcome measures
Measure	Ipatasertib + Paclitaxel n=76 Participants Participants received ipatasertib orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel intravenous (IV) infusion every week (QW) for 3 cycles (12 total doses).	Placebo + Paclitaxel n=75 Participants Participants received placebo (matching to ipatasertib) orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel IV infusion QW for 3 cycles (12 total doses).
Percentage of Participants With Adverse Events	100 percentage of participants	98.7 percentage of participants

SECONDARY outcome

Timeframe: 0.5 and 4 hours post dose on Day 1 of Cycle 1, 166 and 170 hours post dose from Day 1 of Cycle 1 (Cycle length = 28 days)

Population: The ITT population included all randomized participants. Reported here are data for participants with data available.

Plasma samples for pharmacokinetic characterization was collected at various timepoints in all participants.

Outcome measures

Outcome measures
Measure	Ipatasertib + Paclitaxel n=73 Participants Participants received ipatasertib orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel intravenous (IV) infusion every week (QW) for 3 cycles (12 total doses).	Placebo + Paclitaxel Participants received placebo (matching to ipatasertib) orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel IV infusion QW for 3 cycles (12 total doses).
Plasma Concentrations of Ipatasertib on Day 1 and Day 8 0.5 hours	290 ng/mL Standard Deviation 312	—
Plasma Concentrations of Ipatasertib on Day 1 and Day 8 4 hours	196 ng/mL Standard Deviation 93.0	—
Plasma Concentrations of Ipatasertib on Day 1 and Day 8 166 hours	37.5 ng/mL Standard Deviation 28.3	—
Plasma Concentrations of Ipatasertib on Day 1 and Day 8 170 hours	355 ng/mL Standard Deviation 204	—

SECONDARY outcome

Timeframe: 0.5 and 4 hours post dose on Day 1 of Cycle 1, 166 and 170 hours post dose from Day 1 of Cycle 1 (Cycle length = 28 days)

Population: The ITT population included all participants.

Plasma samples for pharmacokinetic characterization was collected on Day 1 and Day 8 in all participants.

Outcome measures

Outcome measures
Measure	Ipatasertib + Paclitaxel n=76 Participants Participants received ipatasertib orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel intravenous (IV) infusion every week (QW) for 3 cycles (12 total doses).	Placebo + Paclitaxel Participants received placebo (matching to ipatasertib) orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel IV infusion QW for 3 cycles (12 total doses).
Minimum Observed Plasma Concentration (Cmin) of Ipatasertib	37.5 ng/mL Standard Deviation 28.3	—

Adverse Events

Ipatasertib + Paclitaxel

Serious events: 10 serious events

Other events: 76 other events

Deaths: 1 deaths

Placebo + Paclitaxel

Serious events: 3 serious events

Other events: 73 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ipatasertib + Paclitaxel n=76 participants at risk Participants received ipatasertib orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel intravenous (IV) infusion every week (QW) for 3 cycles (12 total doses).	Placebo + Paclitaxel n=75 participants at risk Participants received placebo (matching to ipatasertib) orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel IV infusion QW for 3 cycles (12 total doses).
Infections and infestations Device related infection	2.6% 2/76 • 2 years and 6 months The safety population was identical to the ITT population. The ITT population comprised all 151 randomized patients.	0.00% 0/75 • 2 years and 6 months The safety population was identical to the ITT population. The ITT population comprised all 151 randomized patients.
Infections and infestations Pneumonia	1.3% 1/76 • 2 years and 6 months The safety population was identical to the ITT population. The ITT population comprised all 151 randomized patients.	1.3% 1/75 • 2 years and 6 months The safety population was identical to the ITT population. The ITT population comprised all 151 randomized patients.
Infections and infestations Atypical pneumonia	1.3% 1/76 • 2 years and 6 months The safety population was identical to the ITT population. The ITT population comprised all 151 randomized patients.	0.00% 0/75 • 2 years and 6 months The safety population was identical to the ITT population. The ITT population comprised all 151 randomized patients.
General disorders Pyrexia	1.3% 1/76 • 2 years and 6 months The safety population was identical to the ITT population. The ITT population comprised all 151 randomized patients.	1.3% 1/75 • 2 years and 6 months The safety population was identical to the ITT population. The ITT population comprised all 151 randomized patients.
General disorders Chest pain	1.3% 1/76 • 2 years and 6 months The safety population was identical to the ITT population. The ITT population comprised all 151 randomized patients.	0.00% 0/75 • 2 years and 6 months The safety population was identical to the ITT population. The ITT population comprised all 151 randomized patients.
General disorders Complication associated with device	1.3% 1/76 • 2 years and 6 months The safety population was identical to the ITT population. The ITT population comprised all 151 randomized patients.	0.00% 0/75 • 2 years and 6 months The safety population was identical to the ITT population. The ITT population comprised all 151 randomized patients.
General disorders General physical health deterioration	0.00% 0/76 • 2 years and 6 months The safety population was identical to the ITT population. The ITT population comprised all 151 randomized patients.	1.3% 1/75 • 2 years and 6 months The safety population was identical to the ITT population. The ITT population comprised all 151 randomized patients.
Blood and lymphatic system disorders Sickle cell anaemia with crisis	1.3% 1/76 • 2 years and 6 months The safety population was identical to the ITT population. The ITT population comprised all 151 randomized patients.	0.00% 0/75 • 2 years and 6 months The safety population was identical to the ITT population. The ITT population comprised all 151 randomized patients.
Gastrointestinal disorders Diarrhoea	1.3% 1/76 • 2 years and 6 months The safety population was identical to the ITT population. The ITT population comprised all 151 randomized patients.	0.00% 0/75 • 2 years and 6 months The safety population was identical to the ITT population. The ITT population comprised all 151 randomized patients.
Metabolism and nutrition disorders Dehydration	1.3% 1/76 • 2 years and 6 months The safety population was identical to the ITT population. The ITT population comprised all 151 randomized patients.	0.00% 0/75 • 2 years and 6 months The safety population was identical to the ITT population. The ITT population comprised all 151 randomized patients.
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.3% 1/76 • 2 years and 6 months The safety population was identical to the ITT population. The ITT population comprised all 151 randomized patients.	0.00% 0/75 • 2 years and 6 months The safety population was identical to the ITT population. The ITT population comprised all 151 randomized patients.

Other adverse events

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER