Trial Outcomes & Findings for A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (NCT NCT04191499)

NCT ID: NCT04191499

Last Updated: 2026-01-06

Results Overview

PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 or death from any cause (whichever occurs first). Progressive disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions was also considered progression. Data for participants without the occurrence of PD or death as of the clinical cutoff date (CCOD) were censored at the time of the last tumor assessment prior to the CCOD. Median PFS was calculated using the Kaplan-Meier methodology.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE2/PHASE3
• Target enrollment: 325 participants
• Primary outcome timeframe: Up to 3.7 years
• Results posted on: 2026-01-06

Participant Flow

Participants took part in the study across 123 investigative centers in 28 countries. This study is still ongoing.

A total of 325 participants with phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit, alpha isoform (PIK3CA) mutation, hormone receptor-positive, human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer were randomized in 1:1 ratio to Inavolisib+ Palbociclib + Fulvestrant (Inavo+Palbo+Fulv) arm or Placebo + Palbociclib + Fulvestrant (Pbo+Palbo+Fulv) arm in this study.

Participant milestones

Measure	Inavo+Palbo+Fulv Participants received inavolisib, 9 milligrams (mg), orally, once daily (QD) on Days 1-28 of each 28 day cycle along with palbociclib 125 mg, orally, QD on Days 1-21 and fulvestrant, 500 mg, intramuscular (IM) injections on Days 1 and 15 of Cycle 1 and then on Day 1 of each subsequent 28 day cycle until unequivocal disease progression, unacceptable toxicity, participant withdrawal of consent, or study termination.	Pbo+Palbo+Fulv Participants received placebo, orally, QD on Days 1-28 of each 28 day cycle along with palbociclib 125 mg, orally, QD on Days 1-21 and fulvestrant, 500 mg, IM injections on Days 1 and 15 of Cycle 1 and then of Day 1 of each subsequent 28 day cycle until unequivocal disease progression, unacceptable toxicity, participant withdrawal of consent, or study termination.
Overall Study STARTED	161	164
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	161	164

Reasons for withdrawal

Measure	Inavo+Palbo+Fulv Participants received inavolisib, 9 milligrams (mg), orally, once daily (QD) on Days 1-28 of each 28 day cycle along with palbociclib 125 mg, orally, QD on Days 1-21 and fulvestrant, 500 mg, intramuscular (IM) injections on Days 1 and 15 of Cycle 1 and then on Day 1 of each subsequent 28 day cycle until unequivocal disease progression, unacceptable toxicity, participant withdrawal of consent, or study termination.	Pbo+Palbo+Fulv Participants received placebo, orally, QD on Days 1-28 of each 28 day cycle along with palbociclib 125 mg, orally, QD on Days 1-21 and fulvestrant, 500 mg, IM injections on Days 1 and 15 of Cycle 1 and then of Day 1 of each subsequent 28 day cycle until unequivocal disease progression, unacceptable toxicity, participant withdrawal of consent, or study termination.
Overall Study Adverse Event	1	0
Overall Study Death	42	55
Overall Study Lost to Follow-up	4	1
Overall Study Physician Decision	1	0
Overall Study Progressive Disease	1	0
Overall Study Symptomatic Deterioration	1	0
Overall Study Withdrawal by Subject	7	11
Overall Study Ongoing in the study	104	97

Baseline Characteristics

A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer

Baseline characteristics by cohort

Measure	Inavo+Palbo+Fulv n=161 Participants Participants received inavolisib, 9 mg, orally, QD on Days 1-28 of each 28 day cycle along with palbociclib 125 mg, orally, QD on Days 1-21 and fulvestrant, 500 mg, IM injections on Days 1 and 15 of Cycle 1 and then on Day 1 of each subsequent 28 day cycle until unequivocal disease progression, unacceptable toxicity, participant withdrawal of consent, or study termination.	Pbo+Palbo+Fulv n=164 Participants Participants received placebo, orally, QD on Days 1-28 of each 28 day cycle along with palbociclib 125 mg, orally, QD on Days 1-21 and fulvestrant, 500 mg, IM injections on Days 1 and 15 of Cycle 1 and then of Day 1 of each subsequent 28 day cycle until unequivocal disease progression, unacceptable toxicity, participant withdrawal of consent, or study termination.	Total n=325 Participants Total of all reporting groups
Age, Continuous	53.8 years STANDARD_DEVIATION 10.9 • n=37 Participants	54.1 years STANDARD_DEVIATION 11.2 • n=56 Participants	54.0 years STANDARD_DEVIATION 11.1 • n=82 Participants
Sex: Female, Male Female	156 Participants n=37 Participants	163 Participants n=56 Participants	319 Participants n=82 Participants
Sex: Female, Male Male	5 Participants n=37 Participants	1 Participants n=56 Participants	6 Participants n=82 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=37 Participants	10 Participants n=56 Participants	20 Participants n=82 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	145 Participants n=37 Participants	149 Participants n=56 Participants	294 Participants n=82 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=37 Participants	5 Participants n=56 Participants	11 Participants n=82 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=37 Participants	0 Participants n=56 Participants	0 Participants n=82 Participants
Race (NIH/OMB) Asian	61 Participants n=37 Participants	63 Participants n=56 Participants	124 Participants n=82 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=37 Participants	0 Participants n=56 Participants	0 Participants n=82 Participants
Race (NIH/OMB) Black or African American	1 Participants n=37 Participants	1 Participants n=56 Participants	2 Participants n=82 Participants
Race (NIH/OMB) White	94 Participants n=37 Participants	97 Participants n=56 Participants	191 Participants n=82 Participants
Race (NIH/OMB) More than one race	0 Participants n=37 Participants	0 Participants n=56 Participants	0 Participants n=82 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=37 Participants	3 Participants n=56 Participants	8 Participants n=82 Participants

PRIMARY outcome

Timeframe: Up to 3.7 years

Population: FAS included all participants who were randomized to receive the treatment they were assigned.

PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 or death from any cause (whichever occurs first). Progressive disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions was also considered progression. Data for participants without the occurrence of PD or death as of the clinical cutoff date (CCOD) were censored at the time of the last tumor assessment prior to the CCOD. Median PFS was calculated using the Kaplan-Meier methodology.

Outcome measures

Measure	Inavo+Palbo+Fulv n=161 Participants Participants received inavolisib, 9 mg, orally, QD on Days 1-28 of each 28 day cycle along with palbociclib 125 mg, orally, QD on Days 1-21 and fulvestrant, 500 mg, IM injections on Days 1 and 15 of Cycle 1 and then on Day 1 of each subsequent 28 day cycle until unequivocal disease progression, unacceptable toxicity, participant withdrawal of consent, or study termination.	Pbo+Palbo+Fulv n=164 Participants Participants received placebo, orally, QD on Days 1-28 of each 28 day cycle along with palbociclib 125 mg, orally, QD on Days 1-21 and fulvestrant, 500 mg, IM injections on Days 1 and 15 of Cycle 1 and then of Day 1 of each subsequent 28 day cycle until unequivocal disease progression, unacceptable toxicity, participant withdrawal of consent, or study termination.
Progression-Free Survival (PFS)	15 months Interval 11.3 to 20.5	7.3 months Interval 5.6 to 9.3

SECONDARY outcome

Timeframe: Up to approximately 6 years

ORR is defined as the percentage of participants with a complete response (CR) and/or partial response (PR) on at least two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to RECIST v1.1. CR is defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the smallest sum in the study (nadir), including baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 6 years

BOR is defined as the percentage of participants with a CR or PR, as determined by the investigator according to RECIST v1.1. CR is defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the smallest sum in the study (nadir), including baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 6 years

DOR is defined as the time from the first occurrence of a CR or PR to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1, or death from any cause (whichever occurs first). CR is defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the smallest sum in the study (nadir), including baseline. PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 6 years

CBR is defined as the percentage of participants with a CR, PR, and/or stable disease (SD) for at least 24 weeks, as determined by the investigator according to RECIST v1.1. CR= disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR=at least a 30% decrease in the sum of diameters of target lesions, taking as reference the smallest sum in the study (nadir), including baseline. PD=at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in the study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum in the study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 6 years

OS is defined as the time from randomization to death from any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From randomization to first documentation of a ≥ 2-point increase (Up to approximately 6 years)

TTD in pain is defined as the time from randomization to the first documentation of a ≥ 2-point increase from baseline on the "worst pain" item from the Brief Pain Inventory-Short Form (BPI-SF). BPI-SF is a self-administered questionnaire in which the participant was asked to rate severity on a 10-point scale where 0 represents 'No pain/No interference' and 10 represents 'Pain/Interference as bad as you can imagine'. A ≥2-point change is defined as clinically meaningful difference.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Treatment: Day 1 of Cycles 1-3, then Day 1 of every other cycle until treatment discontinuation. Post-treatment: Every 8 weeks for 2 years, then every 12 weeks thereafter, to end of study (up to 6 years) (Cycle length = 28 days)]

TTD in physical function is defined as the time from randomization to the first documentation of a ≥ 10-point decrease from baseline held for two consecutive cycles or initial decrease followed by death or treatment discontinuation within three weeks of last assessment in the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30) PF scale (items 1-5). A ≥10-point change is defined as a clinically meaningful difference. EORTC QLQ-C30 is a cancer-specific health-related quality-of life (QoL) questionnaire with 30 questions. For the PF scale, participant responses to 5 questions about daily activities (strenuous activities, long walks, short walks, bed/chair rest & needing help with eating, dressing, washing themselves, or using the toilet) is scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating worst functioning.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Treatment: Day 1 of Cycles 1-3, then Day 1 of every other cycle until treatment discontinuation. Post-treatment: Every 8 weeks for 2 years, then every 12 weeks thereafter, to end of study (up to 6 years) (Cycle length = 28 days)]

TTD in Role Function is defined as the time from randomization to the first documentation of a ≥ 10-point decrease from baseline held for two consecutive cycles, or initial decrease followed by death or treatment discontinuation within three weeks of last assessment in the EORTC QLQ-C30 RF scale (items 6 and 7). A ≥10-point change is defined as clinically meaningful difference. EORTC QLQ-C30 is a cancer specific health-related QoL questionnaire. For the role functioning scale, participant responses to the 2 questions "Q6: Were you limited in doing either your work or daily activities" and "Q7: Were you limited in pursuing your hobbies or other leisure time activities" were scored on a 4-point scale (1=Not at All to 4=Very Much). The scores were linearly transformed on a scale of 0 to 100, with a low score indicating better functioning.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Treatment: Day 1 of Cycles 1-3, then Day 1 of every other cycle until treatment discontinuation. Post-treatment: Every 8 weeks for 2 years, then every 12 weeks thereafter, to end of study (up to 6 years) (Cycle length = 28 days)]

TTD in (GHS)/health-related quality of life (HRQoL) is defined as the time from randomization to the first documentation of a ≥ 10-point decrease from baseline held for two consecutive cycles, or initial decrease followed by death or treatment discontinuation within three weeks of last assessment in the EORTC QLQ-30 GHS/HRQoL scale. A ≥10-point change is defined as clinically meaningful difference. EORTC QLQ-C30 is a cancer specific health-related QoL questionnaire. Participant responses to the questions regarding Global Health Status (Q29: GHS; "How would you rate your overall health during the past week?") and Quality of Life (Q30: QoL; "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better outcome.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 6 years

An AE is an untoward medical occurrence in participant administered a pharmaceutical product & regardless of causal relationship with this treatment. An AE can therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Predose on Cycle 1 Days 1, 8 and 15 and Cycle 2 Day 15; 3 hours post-dose on Cycle 1 Days 1 and 15 (Cycle length = 28 days)

Population: Pharmacokinetic (PK) evaluable population included all participants who received at least one dose of study drug, had at least one post-baseline sample, and was based on the treatment participants actually received. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.

Outcome measures

Measure	Inavo+Palbo+Fulv n=151 Participants Participants received inavolisib, 9 mg, orally, QD on Days 1-28 of each 28 day cycle along with palbociclib 125 mg, orally, QD on Days 1-21 and fulvestrant, 500 mg, IM injections on Days 1 and 15 of Cycle 1 and then on Day 1 of each subsequent 28 day cycle until unequivocal disease progression, unacceptable toxicity, participant withdrawal of consent, or study termination.	Pbo+Palbo+Fulv Participants received placebo, orally, QD on Days 1-28 of each 28 day cycle along with palbociclib 125 mg, orally, QD on Days 1-21 and fulvestrant, 500 mg, IM injections on Days 1 and 15 of Cycle 1 and then of Day 1 of each subsequent 28 day cycle until unequivocal disease progression, unacceptable toxicity, participant withdrawal of consent, or study termination.
Plasma Concentration of Inavolisib Predose, Cycle 1 Day 1	NA nanogram/milliliter (ng/ml) Geometric Coefficient of Variation NA The data was not estimable as the samples were below the lower limit of quantification (BLLQ).	—
Plasma Concentration of Inavolisib 3 hours Post-dose, Cycle 1 Day 1	36 nanogram/milliliter (ng/ml) Geometric Coefficient of Variation 223	—
Plasma Concentration of Inavolisib Predose, Cycle 1 Day 8	17.8 nanogram/milliliter (ng/ml) Geometric Coefficient of Variation 134	—
Plasma Concentration of Inavolisib Predose, Cycle 1 Day 15	13.6 nanogram/milliliter (ng/ml) Geometric Coefficient of Variation 240	—
Plasma Concentration of Inavolisib 3 hours Post-dose, Cycle 1 Day 15	59.2 nanogram/milliliter (ng/ml) Geometric Coefficient of Variation 119	—
Plasma Concentration of Inavolisib Predose, Cycle 2 Day 15	16.9 nanogram/milliliter (ng/ml) Geometric Coefficient of Variation 124	—

SECONDARY outcome

Timeframe: Predose on Cycle 1 Days 1, 8 and 15 and Cycle 2 Day 15; 3 hours post-dose on Cycle 1 Days 1 and 15 (Cycle length = 28 days)

Population: PK evaluable population included all participants who received at least one dose of study drug, had at least one post-baseline sample, and was based on the treatment participants actually received. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.

Outcome measures

Measure	Inavo+Palbo+Fulv n=154 Participants Participants received inavolisib, 9 mg, orally, QD on Days 1-28 of each 28 day cycle along with palbociclib 125 mg, orally, QD on Days 1-21 and fulvestrant, 500 mg, IM injections on Days 1 and 15 of Cycle 1 and then on Day 1 of each subsequent 28 day cycle until unequivocal disease progression, unacceptable toxicity, participant withdrawal of consent, or study termination.	Pbo+Palbo+Fulv n=153 Participants Participants received placebo, orally, QD on Days 1-28 of each 28 day cycle along with palbociclib 125 mg, orally, QD on Days 1-21 and fulvestrant, 500 mg, IM injections on Days 1 and 15 of Cycle 1 and then of Day 1 of each subsequent 28 day cycle until unequivocal disease progression, unacceptable toxicity, participant withdrawal of consent, or study termination.
Plasma Concentration of Palbociclib Predose, Cycle 1 Day 15	69.9 ng/ml Geometric Coefficient of Variation 78	73.3 ng/ml Geometric Coefficient of Variation 65
Plasma Concentration of Palbociclib 3 hours Post-dose, Cycle 1 Day 15	96.7 ng/ml Geometric Coefficient of Variation 55	98.0 ng/ml Geometric Coefficient of Variation 62
Plasma Concentration of Palbociclib 3 hours Post-dose, Cycle 1 Day 1	20.7 ng/ml Geometric Coefficient of Variation 182	22.9 ng/ml Geometric Coefficient of Variation 251
Plasma Concentration of Palbociclib Predose, Cycle 1 Day 8	73.9 ng/ml Geometric Coefficient of Variation 56	74.5 ng/ml Geometric Coefficient of Variation 50
Plasma Concentration of Palbociclib Predose, Cycle 2 Day 15	58.5 ng/ml Geometric Coefficient of Variation 111	66.9 ng/ml Geometric Coefficient of Variation 90
Plasma Concentration of Palbociclib Predose, Cycle 1 Day 1	NA ng/ml Geometric Coefficient of Variation NA The data was not estimable as the samples were BLLQ.	NA ng/ml Geometric Coefficient of Variation NA The data was not estimable as the samples were BLLQ.

SECONDARY outcome

Timeframe: Predose on Cycle 1 Days 1, 8 and 15 and Cycle 2 Day 15; 3 hours post-dose on Cycle 1 Days 1 and 15 (Cycle length = 28 days)

Population: PK evaluable population included all participants who received at least one dose of study drug, had at least one post-baseline sample, and was based on the treatment participants actually received. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.

Outcome measures

Measure	Inavo+Palbo+Fulv n=154 Participants Participants received inavolisib, 9 mg, orally, QD on Days 1-28 of each 28 day cycle along with palbociclib 125 mg, orally, QD on Days 1-21 and fulvestrant, 500 mg, IM injections on Days 1 and 15 of Cycle 1 and then on Day 1 of each subsequent 28 day cycle until unequivocal disease progression, unacceptable toxicity, participant withdrawal of consent, or study termination.	Pbo+Palbo+Fulv n=154 Participants Participants received placebo, orally, QD on Days 1-28 of each 28 day cycle along with palbociclib 125 mg, orally, QD on Days 1-21 and fulvestrant, 500 mg, IM injections on Days 1 and 15 of Cycle 1 and then of Day 1 of each subsequent 28 day cycle until unequivocal disease progression, unacceptable toxicity, participant withdrawal of consent, or study termination.
Plasma Concentration of Fulvestrant 3 hours Post-dose, Cycle 1 Day 15	12.2 ng/ml Geometric Coefficient of Variation 44	11.1 ng/ml Geometric Coefficient of Variation 43
Plasma Concentration of Fulvestrant Predose, Cycle 2 Day 15	18.0 ng/ml Geometric Coefficient of Variation 37	17.3 ng/ml Geometric Coefficient of Variation 37
Plasma Concentration of Fulvestrant Predose, Cycle 1 Day 1	NA ng/ml Geometric Coefficient of Variation NA The data was not estimable as the samples were BLLQ.	NA ng/ml Geometric Coefficient of Variation NA The data was not estimable as the samples were BLLQ.
Plasma Concentration of Fulvestrant 3 hours Post-dose, Cycle 1 Day 1	1.03 ng/ml Geometric Coefficient of Variation 200	0.815 ng/ml Geometric Coefficient of Variation 200
Plasma Concentration of Fulvestrant Predose, Cycle 1 Day 8	17.5 ng/ml Geometric Coefficient of Variation 46	16.2 ng/ml Geometric Coefficient of Variation 46
Plasma Concentration of Fulvestrant Predose, Cycle 1 Day 15	11.9 ng/ml Geometric Coefficient of Variation 37	10.9 ng/ml Geometric Coefficient of Variation 42

Adverse Events

Inavo+Palbo+Fulv

Serious events: 39 serious events

Other events: 157 other events

Deaths: 43 deaths

Pbo+Palbo+Fulv

Serious events: 17 serious events

Other events: 158 other events

Deaths: 54 deaths

Serious adverse events

Measure	Inavo+Palbo+Fulv n=162 participants at risk Participants received inavolisib, 9 mg, orally, QD on Days 1-28 of each 28 day cycle along with palbociclib 125 mg, orally, QD on Days 1-21 and fulvestrant, 500 mg, IM injections on Days 1 and 15 of Cycle 1 and then on Day 1 of each subsequent 28 day cycle until unequivocal disease progression, unacceptable toxicity, participant withdrawal of consent, or study termination.	Pbo+Palbo+Fulv n=162 participants at risk Participants received placebo, orally, QD on Days 1-28 of each 28 day cycle along with palbociclib 125 mg, orally, QD on Days 1-21 and fulvestrant, 500 mg, IM injections on Days 1 and 15 of Cycle 1 and then of Day 1 of each subsequent 28 day cycle until unequivocal disease progression, unacceptable toxicity, participant withdrawal of consent, or study termination.
Blood and lymphatic system disorders Anaemia	1.9% 3/162 • Number of events 3 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Blood and lymphatic system disorders Febrile neutropenia	1.9% 3/162 • Number of events 3 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Blood and lymphatic system disorders Neutropenia	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Blood and lymphatic system disorders Thrombocytopenia	0.62% 1/162 • Number of events 2 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Cardiac disorders Acute coronary syndrome	1.2% 2/162 • Number of events 2 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Cardiac disorders Atrial fibrillation	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Cardiac disorders Cardiac arrest	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Gastrointestinal disorders Abdominal pain	0.62% 1/162 • Number of events 2 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Gastrointestinal disorders Anal fistula	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Gastrointestinal disorders Diarrhoea	1.2% 2/162 • Number of events 2 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Gastrointestinal disorders Dysphagia	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Gastrointestinal disorders Intestinal perforation	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Gastrointestinal disorders Nausea	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Gastrointestinal disorders Oesophageal stenosis	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Gastrointestinal disorders Vomiting	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	1.2% 2/162 • Number of events 2 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
General disorders Chest pain	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
General disorders Death	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
General disorders Malaise	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
General disorders Pyrexia	1.2% 2/162 • Number of events 2 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Infections and infestations Anal abscess	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Infections and infestations COVID-19	2.5% 4/162 • Number of events 4 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Infections and infestations COVID-19 pneumonia	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Infections and infestations Cellulitis	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Infections and infestations Clostridium difficile colitis	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Infections and infestations Device related infection	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Infections and infestations Lung abscess	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Infections and infestations Pneumonia	1.9% 3/162 • Number of events 3 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Infections and infestations Upper respiratory tract infection	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Infections and infestations Urinary tract infection	1.2% 2/162 • Number of events 2 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Injury, poisoning and procedural complications Ankle fracture	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Injury, poisoning and procedural complications Post procedural fistula	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Injury, poisoning and procedural complications Procedural headache	0.62% 1/162 • Number of events 2 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Injury, poisoning and procedural complications Snake bite	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Investigations Alanine aminotransferase increased	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Investigations Aspartate aminotransferase increased	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Investigations Platelet count decreased	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Investigations White blood cell count decreased	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Metabolism and nutrition disorders Hypocalcaemia	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Metabolism and nutrition disorders Hypokalaemia	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Metabolism and nutrition disorders Tetany	0.62% 1/162 • Number of events 2 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Musculoskeletal and connective tissue disorders Flank pain	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Nervous system disorders Cerebral haemorrhage	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Nervous system disorders Cerebrovascular accident	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Nervous system disorders Haemorrhage intracranial	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Nervous system disorders Syncope	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Product Issues Device dislocation	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Renal and urinary disorders Acute kidney injury	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	1.2% 2/162 • Number of events 2 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Skin and subcutaneous tissue disorders Skin ulcer	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Vascular disorders Embolism	0.62% 1/162 • Number of events 2 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.00% 0/162 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.

Other adverse events

Measure	Inavo+Palbo+Fulv n=162 participants at risk Participants received inavolisib, 9 mg, orally, QD on Days 1-28 of each 28 day cycle along with palbociclib 125 mg, orally, QD on Days 1-21 and fulvestrant, 500 mg, IM injections on Days 1 and 15 of Cycle 1 and then on Day 1 of each subsequent 28 day cycle until unequivocal disease progression, unacceptable toxicity, participant withdrawal of consent, or study termination.	Pbo+Palbo+Fulv n=162 participants at risk Participants received placebo, orally, QD on Days 1-28 of each 28 day cycle along with palbociclib 125 mg, orally, QD on Days 1-21 and fulvestrant, 500 mg, IM injections on Days 1 and 15 of Cycle 1 and then of Day 1 of each subsequent 28 day cycle until unequivocal disease progression, unacceptable toxicity, participant withdrawal of consent, or study termination.
Blood and lymphatic system disorders Anaemia	35.8% 58/162 • Number of events 102 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	36.4% 59/162 • Number of events 104 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Blood and lymphatic system disorders Leukopenia	17.3% 28/162 • Number of events 81 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	24.7% 40/162 • Number of events 80 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Blood and lymphatic system disorders Neutropenia	54.3% 88/162 • Number of events 251 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	54.9% 89/162 • Number of events 215 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Blood and lymphatic system disorders Thrombocytopenia	22.2% 36/162 • Number of events 95 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	25.3% 41/162 • Number of events 65 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Eye disorders Dry eye	8.6% 14/162 • Number of events 14 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	3.1% 5/162 • Number of events 5 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Gastrointestinal disorders Abdominal pain	9.9% 16/162 • Number of events 20 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	6.2% 10/162 • Number of events 15 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Gastrointestinal disorders Abdominal pain upper	8.6% 14/162 • Number of events 16 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	6.8% 11/162 • Number of events 13 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Gastrointestinal disorders Constipation	14.8% 24/162 • Number of events 35 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	14.2% 23/162 • Number of events 27 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Gastrointestinal disorders Diarrhoea	48.1% 78/162 • Number of events 156 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	16.0% 26/162 • Number of events 35 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Gastrointestinal disorders Dry mouth	5.6% 9/162 • Number of events 10 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	3.1% 5/162 • Number of events 5 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Gastrointestinal disorders Dyspepsia	8.0% 13/162 • Number of events 15 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	2.5% 4/162 • Number of events 5 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Gastrointestinal disorders Gastrooesophageal reflux disease	8.0% 13/162 • Number of events 15 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	1.2% 2/162 • Number of events 2 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Gastrointestinal disorders Nausea	27.2% 44/162 • Number of events 58 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	16.7% 27/162 • Number of events 39 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Gastrointestinal disorders Stomatitis	32.7% 53/162 • Number of events 80 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	16.7% 27/162 • Number of events 37 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Gastrointestinal disorders Toothache	5.6% 9/162 • Number of events 10 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	2.5% 4/162 • Number of events 6 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Gastrointestinal disorders Vomiting	14.8% 24/162 • Number of events 47 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	3.7% 6/162 • Number of events 7 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
General disorders Asthenia	15.4% 25/162 • Number of events 39 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	13.6% 22/162 • Number of events 31 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
General disorders Fatigue	23.5% 38/162 • Number of events 43 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	13.0% 21/162 • Number of events 22 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
General disorders Mucosal inflammation	18.5% 30/162 • Number of events 56 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	9.9% 16/162 • Number of events 21 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
General disorders Pyrexia	8.0% 13/162 • Number of events 15 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	8.0% 13/162 • Number of events 16 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Infections and infestations COVID-19	21.0% 34/162 • Number of events 36 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	9.9% 16/162 • Number of events 17 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Infections and infestations Upper respiratory tract infection	8.0% 13/162 • Number of events 14 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	4.3% 7/162 • Number of events 7 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Infections and infestations Urinary tract infection	11.7% 19/162 • Number of events 29 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	7.4% 12/162 • Number of events 14 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Investigations Alanine aminotransferase increased	17.3% 28/162 • Number of events 40 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	13.0% 21/162 • Number of events 29 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Investigations Aspartate aminotransferase increased	17.3% 28/162 • Number of events 35 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	16.0% 26/162 • Number of events 36 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Investigations Blood creatinine increased	5.6% 9/162 • Number of events 16 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	7.4% 12/162 • Number of events 18 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Investigations Blood insulin increased	6.2% 10/162 • Number of events 15 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Investigations Glycosylated haemoglobin increased	8.0% 13/162 • Number of events 16 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	1.2% 2/162 • Number of events 2 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Investigations Lymphocyte count decreased	3.1% 5/162 • Number of events 13 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	6.2% 10/162 • Number of events 15 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Investigations Neutrophil count decreased	38.9% 63/162 • Number of events 251 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	39.5% 64/162 • Number of events 210 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Investigations Platelet count decreased	25.9% 42/162 • Number of events 90 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	21.6% 35/162 • Number of events 68 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Investigations Weight decreased	17.3% 28/162 • Number of events 32 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	0.62% 1/162 • Number of events 1 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Investigations White blood cell count decreased	21.6% 35/162 • Number of events 117 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	21.6% 35/162 • Number of events 90 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Metabolism and nutrition disorders Decreased appetite	23.5% 38/162 • Number of events 44 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	8.6% 14/162 • Number of events 16 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Metabolism and nutrition disorders Hyperglycaemia	53.7% 87/162 • Number of events 178 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	7.4% 12/162 • Number of events 24 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Metabolism and nutrition disorders Hypocalcaemia	8.0% 13/162 • Number of events 14 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	2.5% 4/162 • Number of events 4 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Metabolism and nutrition disorders Hypokalaemia	15.4% 25/162 • Number of events 63 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	6.2% 10/162 • Number of events 11 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Musculoskeletal and connective tissue disorders Arthralgia	9.9% 16/162 • Number of events 17 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	12.3% 20/162 • Number of events 30 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Musculoskeletal and connective tissue disorders Back pain	11.1% 18/162 • Number of events 21 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	9.9% 16/162 • Number of events 17 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Musculoskeletal and connective tissue disorders Muscle spasms	9.9% 16/162 • Number of events 17 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	3.1% 5/162 • Number of events 5 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Musculoskeletal and connective tissue disorders Pain in extremity	5.6% 9/162 • Number of events 10 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	5.6% 9/162 • Number of events 12 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Nervous system disorders Dizziness	6.2% 10/162 • Number of events 11 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	8.0% 13/162 • Number of events 15 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Nervous system disorders Dysgeusia	8.0% 13/162 • Number of events 14 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	3.7% 6/162 • Number of events 6 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Nervous system disorders Headache	21.0% 34/162 • Number of events 41 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	13.6% 22/162 • Number of events 28 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Psychiatric disorders Insomnia	9.9% 16/162 • Number of events 17 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	8.0% 13/162 • Number of events 18 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Respiratory, thoracic and mediastinal disorders Cough	11.1% 18/162 • Number of events 19 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	7.4% 12/162 • Number of events 22 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.8% 11/162 • Number of events 12 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	5.6% 9/162 • Number of events 10 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.6% 9/162 • Number of events 11 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	2.5% 4/162 • Number of events 7 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Skin and subcutaneous tissue disorders Alopecia	18.5% 30/162 • Number of events 30 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	5.6% 9/162 • Number of events 9 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Skin and subcutaneous tissue disorders Dry skin	11.1% 18/162 • Number of events 20 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	4.3% 7/162 • Number of events 7 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Skin and subcutaneous tissue disorders Pruritus	7.4% 12/162 • Number of events 13 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	7.4% 12/162 • Number of events 14 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
Skin and subcutaneous tissue disorders Rash	16.0% 26/162 • Number of events 49 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.	13.0% 21/162 • Number of events 33 • Up to 3.7 years Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.

Additional Information

Medical Communications

Hoffmann-La Roche

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Email: genentech@druginfo.com

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