NCT00567190 · OUTCOME

Number of Participants Who Experienced at Least One Adverse Event During the Post-Treatment Follow-Up Period

A Study to Evaluate Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer · Source last updated 2019-12-13

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

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: From Day 43 after discontinuation of all study medication to end of post-treatment follow-up period (up to 3 years)

What was measured

The post-treatment period was defined as the period following the treatment discontinuation visit. Only the following new adverse events (AEs) should have been reported during the post-treatment follow-up period: 1. Cardiac events (regardless of causality or seriousness) that started up to 1 year after the last dose, except for symptomatic left ventricular systolic dysfunction (regardless of causality) that started up to 3 years after the last dose; and 2. Treatment-related serious AEs, regardless of start date. AEs are listed by Medical Dictionary for Regulatory Activities, Version 21.1 (MedDRA v21.1) System Organ Class (SOC) and Preferred Term (PT); PTs fall under the SOC that is listed immediately above it in the table. Multiple occurrences of the same AE in one participant was counted only once. AEs reported prior to first crossover treatment were included in the Placebo arm, and after that date in the Crossover arm, for participants who crossed over from placebo to pertuzumab.

Analysis population: Safety Population: All participants who received at least one dose of any study medication.

Groups in this outcome

Placebo + Trastuzumab + Docetaxel

This is the placebo safety population, which includes participants who received study treatment with placebo at every cycle. Participants received placebo IV q3w and trastuzumab 6 mg/kg IV q3This is the placebo safety population, which includes participants who received study treatment with placebo at every cycle. Participants received placebo IV q3w and trastuzumab 6 mg/kg IV q3w, plus docetaxel 75 mg/m\^2 IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.

Pertuzumab + Trastuzumab + Docetaxel

This is the pertuzumab safety population, which includes participants who received at least one dose of study treatment with pertuzumab. Participants received pertuzumab 420 milligrams (mg) intravenously (IV) once every 3 weeks (q3w) and trastuzumab 6 milligrams per kilogram (mg/kg) IV q3w, plus docetaxel 75 milligrams per square metre of body surface (mg/m\^2) IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.

Crossover From Placebo to Pertuzumab

Fifty of 406 participants (12.3%) randomized to the placebo treatment arm whose disease had not progressed crossed over to an open-label pertuzumab treatment group between July 2012 and November 2018. Participants received pertuzumab administered as an IV loading dose of 840 mg at cycle 1 then 420 mg IV every q3w. Trastuzumab and docetaxel doses continued in accordance with the pre-crossover placebo treatment regimens and according to dosing specifications indicated in the study protocol. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Placebo + Trastuzumab + Docetaxel	396
Pertuzumab + Trastuzumab + Docetaxel	408
Crossover From Placebo to Pertuzumab	50

Reported measurements

Total with at Least One AE During Post-Treatment

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	18	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	17	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	3	Not reported	Not reported	Not reported	Not reported

Cardiac Disorders (SOC)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	8	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	9	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	1	Not reported	Not reported	Not reported	Not reported

Left Ventricular Dysfunction (PT)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	6	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	5	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	1	Not reported	Not reported	Not reported	Not reported

Cardiac Failure (PT)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	2	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

Bundle Branch Block Left (PT)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	1	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

Cardiopulmonary Failure (PT)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	1	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

Myocardial Ischaemia (PT)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	1	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

Pericardial Effusion (PT)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	1	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

Prinzmetal Angina (PT)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	1	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

General Disorders & Admin. Site Conditions (SOC)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	3	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	2	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

Oedema Peripheral (PT)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	2	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	1	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

Asthenia (PT)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	1	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

Influenza Like Illness (PT)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	1	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

Infections & Infestations (SOC)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	2	Not reported	Not reported	Not reported	Not reported

Influenza (PT)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	1	Not reported	Not reported	Not reported	Not reported

Viral Infection (PT)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	1	Not reported	Not reported	Not reported	Not reported

Abscess Limb (PT)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	1	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

Nasopharyngitis (PT)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	1	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

Subcutaneous Abscess (PT)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	1	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

Musculoskeletal & Connective Tissue Disorders(SOC)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	1	Not reported	Not reported	Not reported	Not reported

Back Pain (PT)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	1	Not reported	Not reported	Not reported	Not reported

Pain in Extremity (PT)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	1	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

Nervous System Disorders (SOC)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	2	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	2	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

Neuropathy Peripheral (PT)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	1	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	1	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

Cognitive Disorder (PT)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	1	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

Dizziness (PT)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	1	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

Headache (PT)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	1	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

Respiratory, Thoracic & Mediastinal Disorders(SOC)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	2	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	1	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

Cough (PT)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	1	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

Dyspnoea (PT)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	1	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

Rhinitis Allergic (PT)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	1	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

Skin & Subcutaneous Tissue Disorders (SOC)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	1	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	2	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

Erythema (PT)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	1	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

Nail Disorder (PT)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	1	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

Rash Macular (PT)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	1	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

Blood & Lymphatic System Disorders (SOC)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	1	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	1	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

Febrile Neutropenia (PT)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	1	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

Leukopenia (PT)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	1	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

Gastrointestinal Disorders (SOC)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	2	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

Diarrhoea (PT)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	1	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

Stomatitis (PT)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	1	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

Endocrine Disorders (SOC)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	1	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

Thyroid Mass (PT)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	1	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

Eye Disorders (SOC)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	1	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

Retinal Detachment (PT)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	1	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

Immune System Disorders (SOC)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	1	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

Iodine Allergy (PT)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	1	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

Investigations (SOC)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	1	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

Aspartate Aminotransferase Increased (PT)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	1	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

Renal & Urinary Disorders (SOC)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	1	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

Dysuria (PT)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	1	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

Reproductive System & Breast Disorders (SOC)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	1	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

Breast Induration (PT)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	1	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

Vascular Disorders (SOC)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	1	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

Venous Thrombosis (PT)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo + Trastuzumab + Docetaxel	0	Not reported	Not reported	Not reported	Not reported
Pertuzumab + Trastuzumab + Docetaxel	1	Not reported	Not reported	Not reported	Not reported
Crossover From Placebo to Pertuzumab	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
18
group Id
OG001
value
17
group Id
OG002
value
3
title
Total with at Least One AE During Post-Treatment
categories
measurements
group Id
OG000
value
8
group Id
OG001
value
9
group Id
OG002
value
1
title
Cardiac Disorders (SOC)
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
5
group Id
OG002
value
1
title
Left Ventricular Dysfunction (PT)
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
2
group Id
OG002
value
0
title
Cardiac Failure (PT)
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
0
title
Bundle Branch Block Left (PT)
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
0
title
Cardiopulmonary Failure (PT)
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
0
title
Myocardial Ischaemia (PT)
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
0
title
Pericardial Effusion (PT)
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
0
title
Prinzmetal Angina (PT)
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
2
group Id
OG002
value
0
title
General Disorders & Admin. Site Conditions (SOC)
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
1
group Id
OG002
value
0
title
Oedema Peripheral (PT)
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
0
title
Asthenia (PT)

denoms

counts
group Id
OG000
value
396
group Id
OG001
value
408
group Id
OG002
value
50
units
Participants

description

groups

description
This is the placebo safety population, which includes participants who received study treatment with placebo at every cycle. Participants received placebo IV q3w and trastuzumab 6 mg/kg IV q3This is the placebo safety population, which includes participants who received study treatment with placebo at every cycle. Participants received placebo IV q3w and trastuzumab 6 mg/kg IV q3w, plus docetaxel 75 mg/m\^2 IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.
id
OG000
title
Placebo + Trastuzumab + Docetaxel
description
This is the pertuzumab safety population, which includes participants who received at least one dose of study treatment with pertuzumab. Participants received pertuzumab 420 milligrams (mg) intravenously (IV) once every 3 weeks (q3w) and trastuzumab 6 milligrams per kilogram (mg/kg) IV q3w, plus docetaxel 75 milligrams per square metre of body surface (mg/m\^2) IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.
id
OG001
title
Pertuzumab + Trastuzumab + Docetaxel
description
Fifty of 406 participants (12.3%) randomized to the placebo treatment arm whose disease had not progressed crossed over to an open-label pertuzumab treatment group between July 2012 and November 2018. Participants received pertuzumab administered as an IV loading dose of 840 mg at cycle 1 then 420 mg IV every q3w. Trastuzumab and docetaxel doses continued in accordance with the pre-crossover placebo treatment regimens and according to dosing specifications indicated in the study protocol. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.
id
OG002
title
Crossover From Placebo to Pertuzumab

param Type

COUNT_OF_PARTICIPANTS

population Description

Safety Population: All participants who received at least one dose of any study medication.

reporting Status

POSTED

time Frame

From Day 43 after discontinuation of all study medication to end of post-treatment follow-up period (up to 3 years)

title

Number of Participants Who Experienced at Least One Adverse Event During the Post-Treatment Follow-Up Period

type

SECONDARY

unit Of Measure

Participants

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Preserved source evidence · Not medical advice