Trial Outcomes & Findings for A Study of ZW25 (Zanidatamab) With Palbociclib Plus Fulvestrant in Patients With HER2+/HR+ Advanced Breast Cancer (NCT NCT04224272)

Last Updated: 2025-08-01

Results Overview

Dose-limiting toxicities, defined using NCI CTCAE version 5.0, are events that 1) occur following administration of ZW25, palbociclib, and fulvestrant, or any combination of ZW25 and 1 or more of these drugs; and 2) meet the criteria as specified in the protocol.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

51 participants

Primary outcome timeframe

Cycle 1 Day 1 to Day 28 (each cycle is 28 days)

Results posted on

2025-08-01

Participant Flow

A total of 51 participants who met all eligibility criteria were enrolled and received treatment.

Participant milestones

Participant milestones
Measure	ZW25 (Zanidatamab) + Palbociclib + Fulvestrant Participants who received an intravenous dose of 20 mg/kg ZW25 (zanidatamab) every 2 weeks (Q2W) in combination with an oral administration of 125 mg palbociclib once daily from Days 1 to 21, and an intramuscular injection of 500 mg fulvestrant Q2W for 3 doses (Cycle 1 Days 1 and 15 and Cycle 2 Day 1), and every 4 weeks (Q4W) thereafter.
Part 1 - Dose Finding STARTED	8
Part 1 - Dose Finding COMPLETED	1
Part 1 - Dose Finding NOT COMPLETED	7
Part 2 - Dose Expansion STARTED	43
Part 2 - Dose Expansion COMPLETED	30
Part 2 - Dose Expansion NOT COMPLETED	13

Reasons for withdrawal

Reasons for withdrawal
Measure	ZW25 (Zanidatamab) + Palbociclib + Fulvestrant Participants who received an intravenous dose of 20 mg/kg ZW25 (zanidatamab) every 2 weeks (Q2W) in combination with an oral administration of 125 mg palbociclib once daily from Days 1 to 21, and an intramuscular injection of 500 mg fulvestrant Q2W for 3 doses (Cycle 1 Days 1 and 15 and Cycle 2 Day 1), and every 4 weeks (Q4W) thereafter.
Part 1 - Dose Finding Death	4
Part 1 - Dose Finding Withdrawal by Subject	2
Part 1 - Dose Finding Lost to Follow-up	1
Part 2 - Dose Expansion Death	10
Part 2 - Dose Expansion Withdrawal by Subject	3

Baseline Characteristics

A Study of ZW25 (Zanidatamab) With Palbociclib Plus Fulvestrant in Patients With HER2+/HR+ Advanced Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ZW25 (Zanidatamab) + Palbociclib + Fulvestrant n=51 Participants Participants who received intravenous dose of 20 mg/kg ZW25 (zanidatamab) every 2 weeks (Q2W) in combination with an oral administration of 125 mg palbociclib once daily from Days 1 to 21, and an intramuscular injection of 500 mg fulvestrant Q2W for 3 doses (Cycle 1 Days 1 and 15 and Cycle 2 Day 1), and every 4 weeks (Q4W) thereafter.
Age, Continuous	54.7 years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	49 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants
Race/Ethnicity, Customized White	42 Participants n=5 Participants
Race/Ethnicity, Customized Multiple	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	3 Participants n=5 Participants
Race/Ethnicity, Customized Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Cycle 1 Day 1 to Day 28 (each cycle is 28 days)

Population: Dose-limiting toxicities were assessed in participants with available data in the Safety Analysis Set.

Outcome measures

Outcome measures
Measure	ZW25 (Zanidatamab) + Palbociclib + Fulvestrant n=8 Participants Participants who received intravenous dose of 20 mg/kg ZW25 (zanidatamab) every 2 weeks (Q2W) in combination with an oral administration of 125 mg palbociclib once daily from Days 1 to 21, and an intramuscular injection of 500 mg fulvestrant Q2W for 3 doses (Cycle 1 Days 1 and 15 and Cycle 2 Day 1), and every 4 weeks (Q4W) thereafter.
Number of Participants With Dose-Limiting Toxicities	1 Participants

PRIMARY outcome

Timeframe: Baseline from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.

Population: Treatment-emergent adverse events were assessed in the Safety Analysis Set.

A treatment-emergent adverse event occurs after the start of study treatment and is defined as any unfavorable or unintended symptom, sign, or disease (including abnormal lab) temporally associated with the use of treatment that may or may not be considered related to treatment. TEAEs were coded using MedDRA v24.0.

Outcome measures

Outcome measures
Measure	ZW25 (Zanidatamab) + Palbociclib + Fulvestrant n=51 Participants Participants who received intravenous dose of 20 mg/kg ZW25 (zanidatamab) every 2 weeks (Q2W) in combination with an oral administration of 125 mg palbociclib once daily from Days 1 to 21, and an intramuscular injection of 500 mg fulvestrant Q2W for 3 doses (Cycle 1 Days 1 and 15 and Cycle 2 Day 1), and every 4 weeks (Q4W) thereafter.
Number of Participants Reporting Grade 3 or Higher Treatment-emergent Adverse Events Any Blood and Lymphatic System Disorders AE	20 Participants
Number of Participants Reporting Grade 3 or Higher Treatment-emergent Adverse Events Neutropenia	16 Participants
Number of Participants Reporting Grade 3 or Higher Treatment-emergent Adverse Events Anaemia	6 Participants
Number of Participants Reporting Grade 3 or Higher Treatment-emergent Adverse Events Thrombocytopenia	3 Participants
Number of Participants Reporting Grade 3 or Higher Treatment-emergent Adverse Events Any Gastrointestinal Disorder AE	13 Participants
Number of Participants Reporting Grade 3 or Higher Treatment-emergent Adverse Events Diarrhoea	8 Participants
Number of Participants Reporting Grade 3 or Higher Treatment-emergent Adverse Events Abdominal pain	1 Participants
Number of Participants Reporting Grade 3 or Higher Treatment-emergent Adverse Events Duodenal ulcer	1 Participants
Number of Participants Reporting Grade 3 or Higher Treatment-emergent Adverse Events Gastric ulcer	1 Participants
Number of Participants Reporting Grade 3 or Higher Treatment-emergent Adverse Events Nausea	1 Participants
Number of Participants Reporting Grade 3 or Higher Treatment-emergent Adverse Events Small intestinal obstruction	1 Participants
Number of Participants Reporting Grade 3 or Higher Treatment-emergent Adverse Events Stomatitis	1 Participants
Number of Participants Reporting Grade 3 or Higher Treatment-emergent Adverse Events Vomiting	1 Participants
Number of Participants Reporting Grade 3 or Higher Treatment-emergent Adverse Events Any Investigation AE	12 Participants
Number of Participants Reporting Grade 3 or Higher Treatment-emergent Adverse Events Neutrophil count decreased	11 Participants
Number of Participants Reporting Grade 3 or Higher Treatment-emergent Adverse Events Ejection fraction decreased	1 Participants
Number of Participants Reporting Grade 3 or Higher Treatment-emergent Adverse Events Transaminases increased	1 Participants
Number of Participants Reporting Grade 3 or Higher Treatment-emergent Adverse Events White blood cell count decreased	1 Participants
Number of Participants Reporting Grade 3 or Higher Treatment-emergent Adverse Events Any Metabolism and Nutrition Disorder AE	8 Participants
Number of Participants Reporting Grade 3 or Higher Treatment-emergent Adverse Events Hypokalaemia	4 Participants
Number of Participants Reporting Grade 3 or Higher Treatment-emergent Adverse Events Hypomagnesaemia	3 Participants
Number of Participants Reporting Grade 3 or Higher Treatment-emergent Adverse Events Hypercalcaemia	2 Participants
Number of Participants Reporting Grade 3 or Higher Treatment-emergent Adverse Events Any General Disorders and Administration Site Conditions AE	2 Participants
Number of Participants Reporting Grade 3 or Higher Treatment-emergent Adverse Events Fatigue	1 Participants
Number of Participants Reporting Grade 3 or Higher Treatment-emergent Adverse Events Pyrexia	1 Participants
Number of Participants Reporting Grade 3 or Higher Treatment-emergent Adverse Events Any Infections and Infestations AE	2 Participants
Number of Participants Reporting Grade 3 or Higher Treatment-emergent Adverse Events COVID-19 pneumonia	1 Participants
Number of Participants Reporting Grade 3 or Higher Treatment-emergent Adverse Events Psoas abscess	1 Participants
Number of Participants Reporting Grade 3 or Higher Treatment-emergent Adverse Events Staphylococcal bacteraemia	1 Participants
Number of Participants Reporting Grade 3 or Higher Treatment-emergent Adverse Events Any Respiratory, Thoracic and Mediastinal Disorder AE	2 Participants
Number of Participants Reporting Grade 3 or Higher Treatment-emergent Adverse Events Pleural effusion	1 Participants
Number of Participants Reporting Grade 3 or Higher Treatment-emergent Adverse Events Pneumothorax	1 Participants
Number of Participants Reporting Grade 3 or Higher Treatment-emergent Adverse Events Any Renal and Urinary Disorder AE	1 Participants
Number of Participants Reporting Grade 3 or Higher Treatment-emergent Adverse Events Acute kidney injury	1 Participants
Number of Participants Reporting Grade 3 or Higher Treatment-emergent Adverse Events Any Skin and Subcutaneous Tissue Disorder AE	1 Participants
Number of Participants Reporting Grade 3 or Higher Treatment-emergent Adverse Events Rash maculo-papular	1 Participants

PRIMARY outcome

Timeframe: 6 months from first dose of any study drug to the date of documented disease progression or death

Population: Progression-free survival 6 will be assessed in the Safety Analysis Set.

The progression-free survival at 6 months (PFS6) is a binary endpoint variable based on the progression-free survival (PFS) time, defined as the proportion of participants having PFS time greater than or equal to 24 weeks (168 days).

Outcome measures

Outcome measures
Measure	ZW25 (Zanidatamab) + Palbociclib + Fulvestrant n=51 Participants Participants who received intravenous dose of 20 mg/kg ZW25 (zanidatamab) every 2 weeks (Q2W) in combination with an oral administration of 125 mg palbociclib once daily from Days 1 to 21, and an intramuscular injection of 500 mg fulvestrant Q2W for 3 doses (Cycle 1 Days 1 and 15 and Cycle 2 Day 1), and every 4 weeks (Q4W) thereafter.
Progression-free Survival 6	34 Participants

SECONDARY outcome

Timeframe: From the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months

Population: Safety data were assessed in the Safety Analysis Set.

A treatment-emergent adverse events (TEAEs) was defined as an adverse event (AE) with onset on or after 1st dose of study treatment through 30 days after final dose of study treatment inclusive. An AE is classified as a serious adverse event (SAE) if fatal, life threatening, requires hospitalization, is disabling/incapacitating, causes congenital anomaly or birth defect, and medically significant. Adverse events of special interest (AESI) include absolute decreases in LVEF greater than or equal to 10 percentage points from baseline, symptomatic heart failure, infusion-related reactions, and all greater than or equal to Grade 2 events of pneumonitis and/or interstitial lung disease, including pulmonary fibrosis.

Outcome measures

Outcome measures
Measure	ZW25 (Zanidatamab) + Palbociclib + Fulvestrant n=51 Participants Participants who received intravenous dose of 20 mg/kg ZW25 (zanidatamab) every 2 weeks (Q2W) in combination with an oral administration of 125 mg palbociclib once daily from Days 1 to 21, and an intramuscular injection of 500 mg fulvestrant Q2W for 3 doses (Cycle 1 Days 1 and 15 and Cycle 2 Day 1), and every 4 weeks (Q4W) thereafter.
Number of Participants Reporting Any Treatment-emergent Adverse Event, Serious Adverse Event, and Adverse Event of Special Interest TEAE	51 Participants
Number of Participants Reporting Any Treatment-emergent Adverse Event, Serious Adverse Event, and Adverse Event of Special Interest SAE	8 Participants
Number of Participants Reporting Any Treatment-emergent Adverse Event, Serious Adverse Event, and Adverse Event of Special Interest AESI	10 Participants

Adverse Events

ZW25 (Zanidatamab) + Palbociclib + Fulvestrant

Serious events: 8 serious events

Other events: 51 other events

Deaths: 14 deaths

Serious adverse events

Serious adverse events
Measure	ZW25 (Zanidatamab) + Palbociclib + Fulvestrant n=51 participants at risk Participants who received an intravenous dose of 20 mg/kg ZW25 (zanidatamab) every 2 weeks (Q2W) in combination with an oral administration of 125 mg palbociclib once daily from Days 1 to 21, and an intramuscular injection of 500 mg fulvestrant Q2W for 3 doses (Cycle 1 Days 1 and 15 and Cycle 2 Day 1), and every 4 weeks (Q4W) thereafter.
Gastrointestinal disorders Duodenal ulcer	2.0% 1/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Gastrointestinal disorders Gastric ulcer	2.0% 1/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Gastrointestinal disorders Small intestinal obstruction	2.0% 1/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Infections and infestations COVID-19	2.0% 1/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Infections and infestations COVID-19 pneumonia	2.0% 1/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Infections and infestations Psoas abscess	2.0% 1/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Infections and infestations Staphylococcal bacteraemia	2.0% 1/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.0% 1/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.0% 1/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Blood and lymphatic system disorders Anaemia	2.0% 1/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Investigations Transaminases increased	2.0% 1/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Metabolism and nutrition disorders Hypercalcaemia	2.0% 1/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Renal and urinary disorders Acute kidney injury	2.0% 1/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.

Other adverse events

Other adverse events
Measure	ZW25 (Zanidatamab) + Palbociclib + Fulvestrant n=51 participants at risk Participants who received an intravenous dose of 20 mg/kg ZW25 (zanidatamab) every 2 weeks (Q2W) in combination with an oral administration of 125 mg palbociclib once daily from Days 1 to 21, and an intramuscular injection of 500 mg fulvestrant Q2W for 3 doses (Cycle 1 Days 1 and 15 and Cycle 2 Day 1), and every 4 weeks (Q4W) thereafter.
Gastrointestinal disorders Nausea	52.9% 27/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Gastrointestinal disorders Diarrhoea	92.2% 47/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Gastrointestinal disorders Stomatitis	41.2% 21/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Gastrointestinal disorders Vomiting	33.3% 17/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Gastrointestinal disorders Abdominal pain	21.6% 11/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Gastrointestinal disorders Dyspepsia	15.7% 8/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Gastrointestinal disorders Constipation	9.8% 5/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Gastrointestinal disorders Abdominal pain upper	7.8% 4/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Gastrointestinal disorders Abdominal distension	5.9% 3/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
General disorders Asthenia	37.3% 19/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
General disorders Fatigue	19.6% 10/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
General disorders Pyrexia	9.8% 5/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
General disorders Injection site pain	5.9% 3/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Blood and lymphatic system disorders Neutropenia	37.3% 19/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Blood and lymphatic system disorders Anaemia	31.4% 16/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Blood and lymphatic system disorders Thrombocytopenia	15.7% 8/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Infections and infestations COVID-19	19.6% 10/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Infections and infestations Urinary tract infection	17.6% 9/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Infections and infestations Nasopharyngitis	7.8% 4/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Metabolism and nutrition disorders Decreased appetite	23.5% 12/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Metabolism and nutrition disorders Hypokalaemia	19.6% 10/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Metabolism and nutrition disorders Hypomagnesaemia	13.7% 7/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Investigations Neutrophil count decreased	27.5% 14/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Investigations Ejection fraction decreased	15.7% 8/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Infections and infestations Platelet count decreased	13.7% 7/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Investigations Weight decreased	11.8% 6/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Investigations White blood cell count decreased	7.8% 4/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Investigations Blood alkaline phosphatase increased	5.9% 3/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Skin and subcutaneous tissue disorders Rash	17.6% 9/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Skin and subcutaneous tissue disorders Pruritus	9.8% 5/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Skin and subcutaneous tissue disorders Alopecia	7.8% 4/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Skin and subcutaneous tissue disorders Rash maculo-papular	7.8% 4/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Skin and subcutaneous tissue disorders Dry skin	5.9% 3/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Musculoskeletal and connective tissue disorders Muscle spasms	17.6% 9/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Musculoskeletal and connective tissue disorders Pain in extremity	9.8% 5/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Musculoskeletal and connective tissue disorders Arthralgia	7.8% 4/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Musculoskeletal and connective tissue disorders Back pain	7.8% 4/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	5.9% 3/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Respiratory, thoracic and mediastinal disorders Epistaxis	19.6% 10/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Respiratory, thoracic and mediastinal disorders Cough	9.8% 5/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.9% 3/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Nervous system disorders Headache	17.6% 9/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Nervous system disorders Dizziness	9.8% 5/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Nervous system disorders Paraesthesia	7.8% 4/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Nervous system disorders Peripheral sensory neuropathy	5.9% 3/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Psychiatric disorders Insomnia	5.9% 3/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.
Vascular disorders Hot flush	9.8% 5/51 • Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.

Additional Information

Clinical Trial Disclosure & Transparency

Jazz Pharmaceuticals Inc.

Phone: 215-832-3750

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place