NCT04191499 · ADVERSE EVENTS

Adverse events

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 · Source last updated 2026-06-15

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Up to 3.7 years
Other-event reporting threshold: 5%

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.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Inavo+Palbo+Fulv 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.	39 / 162	157 / 162	43 / 162
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.	17 / 162	158 / 162	54 / 162

Group identifiers: EG000: Inavo+Palbo+Fulv · EG001: Pbo+Palbo+Fulv

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
3
num At Risk
162
num Events
3
group Id
EG001
num Affected
0
num At Risk
162
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
3
num At Risk
162
num Events
3
group Id
EG001
num Affected
0
num At Risk
162
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
0
num At Risk
162
num Events
0
group Id
EG001
num Affected
1
num At Risk
162
num Events
1
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
162
num Events
2
group Id
EG001
num Affected
0
num At Risk
162
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
2
num At Risk
162
num Events
2
group Id
EG001
num Affected
0
num At Risk
162
num Events
0
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
0
num At Risk
162
num Events
0
group Id
EG001
num Affected
1
num At Risk
162
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
0
num At Risk
162
num Events
0
group Id
EG001
num Affected
1
num At Risk
162
num Events
1
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
162
num Events
2
group Id
EG001
num Affected
0
num At Risk
162
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
162
num Events
1
group Id
EG001
num Affected
0
num At Risk
162
num Events
0
term
Anal fistula
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
2
num At Risk
162
num Events
2
group Id
EG001
num Affected
0
num At Risk
162
num Events
0
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
0
num At Risk
162
num Events
0
group Id
EG001
num Affected
1
num At Risk
162
num Events
1
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
162
num Events
1
group Id
EG001
num Affected
0
num At Risk
162
num Events
0
term
Gastrointestinal haemorrhage

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
58
num At Risk
162
num Events
102
group Id
EG001
num Affected
59
num At Risk
162
num Events
104
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
28
num At Risk
162
num Events
81
group Id
EG001
num Affected
40
num At Risk
162
num Events
80
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
88
num At Risk
162
num Events
251
group Id
EG001
num Affected
89
num At Risk
162
num Events
215
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
36
num At Risk
162
num Events
95
group Id
EG001
num Affected
41
num At Risk
162
num Events
65
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
14
num At Risk
162
num Events
14
group Id
EG001
num Affected
5
num At Risk
162
num Events
5
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
16
num At Risk
162
num Events
20
group Id
EG001
num Affected
10
num At Risk
162
num Events
15
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
14
num At Risk
162
num Events
16
group Id
EG001
num Affected
11
num At Risk
162
num Events
13
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
24
num At Risk
162
num Events
35
group Id
EG001
num Affected
23
num At Risk
162
num Events
27
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
78
num At Risk
162
num Events
156
group Id
EG001
num Affected
26
num At Risk
162
num Events
35
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
9
num At Risk
162
num Events
10
group Id
EG001
num Affected
5
num At Risk
162
num Events
5
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
13
num At Risk
162
num Events
15
group Id
EG001
num Affected
4
num At Risk
162
num Events
5
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
13
num At Risk
162
num Events
15
group Id
EG001
num Affected
2
num At Risk
162
num Events
2
term
Gastrooesophageal reflux disease

Complete source fields

description

event Groups

deaths Num Affected
43
deaths Num At Risk
162
description
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.
id
EG000
other Num Affected
157
other Num At Risk
162
serious Num Affected
39
serious Num At Risk
162
title
Inavo+Palbo+Fulv
deaths Num Affected
54
deaths Num At Risk
162
description
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.
id
EG001
other Num Affected
158
other Num At Risk
162
serious Num Affected
17
serious Num At Risk
162
title
Pbo+Palbo+Fulv

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
58
num At Risk
162
num Events
102
group Id
EG001
num Affected
59
num At Risk
162
num Events
104
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
28
num At Risk
162
num Events
81
group Id
EG001
num Affected
40
num At Risk
162
num Events
80
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
88
num At Risk
162
num Events
251
group Id
EG001
num Affected
89
num At Risk
162
num Events
215
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
36
num At Risk
162
num Events
95
group Id
EG001
num Affected
41
num At Risk
162
num Events
65
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
14
num At Risk
162
num Events
14
group Id
EG001
num Affected
5
num At Risk
162
num Events
5
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
16
num At Risk
162
num Events
20
group Id
EG001
num Affected
10
num At Risk
162
num Events
15
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
14
num At Risk
162
num Events
16
group Id
EG001
num Affected
11
num At Risk
162
num Events
13
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
24
num At Risk
162
num Events
35
group Id
EG001
num Affected
23
num At Risk
162
num Events
27
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
78
num At Risk
162
num Events
156
group Id
EG001
num Affected
26
num At Risk
162
num Events
35
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
9
num At Risk
162
num Events
10
group Id
EG001
num Affected
5
num At Risk
162
num Events
5
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
13
num At Risk
162
num Events
15
group Id
EG001
num Affected
4
num At Risk
162
num Events
5
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
13
num At Risk
162
num Events
15
group Id
EG001
num Affected
2
num At Risk
162
num Events
2
term
Gastrooesophageal reflux disease

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
3
num At Risk
162
num Events
3
group Id
EG001
num Affected
0
num At Risk
162
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
3
num At Risk
162
num Events
3
group Id
EG001
num Affected
0
num At Risk
162
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
0
num At Risk
162
num Events
0
group Id
EG001
num Affected
1
num At Risk
162
num Events
1
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
162
num Events
2
group Id
EG001
num Affected
0
num At Risk
162
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
2
num At Risk
162
num Events
2
group Id
EG001
num Affected
0
num At Risk
162
num Events
0
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
0
num At Risk
162
num Events
0
group Id
EG001
num Affected
1
num At Risk
162
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
0
num At Risk
162
num Events
0
group Id
EG001
num Affected
1
num At Risk
162
num Events
1
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
162
num Events
2
group Id
EG001
num Affected
0
num At Risk
162
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
162
num Events
1
group Id
EG001
num Affected
0
num At Risk
162
num Events
0
term
Anal fistula
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
2
num At Risk
162
num Events
2
group Id
EG001
num Affected
0
num At Risk
162
num Events
0
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
0
num At Risk
162
num Events
0
group Id
EG001
num Affected
1
num At Risk
162
num Events
1
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
162
num Events
1
group Id
EG001
num Affected
0
num At Risk
162
num Events
0
term
Gastrointestinal haemorrhage

time Frame

Up to 3.7 years

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Preserved source evidence · Not medical advice