Trial Outcomes & Findings for Atezolizumab + Pertuzumab + Trastuzumab In CNS Mets In BC (NCT NCT03417544)

NCT ID: NCT03417544

Last Updated: 2025-04-02

Results Overview

The proportion of patients who had confirmed complete response or confirmed partial response, assessed using neuro-oncology-brain metastases (RANO-BM) criteria. RANO-BM assess the response of brain metastases to treatment, using MRI scan. There are four categories as results: Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD), which is separately defined as disappearance of all target lesions, at least a 30% decrease in the sum of the diameters of target lesions, neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as progressive disease (PD) and at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest) or the appearance of one or more new lesions.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE2
• Target enrollment: 19 participants
• Primary outcome timeframe: Participants were evaluated for response every 6 weeks for the first 24 weeks and then every 9 weeks thereafter, through study completion, an average of 24 weeks in the real study data
• Results posted on: 2025-04-02

Participant Flow

Participant milestones

Measure	ATEZOLIZUMAB, PERTUZUMAB, TRASTUZUMAB Patients will receive the following treatment: * Atezolizumab (IV) every 3 weeks (q3w)\] * Pertuzumab (loading dose ), followed q3w thereafter by a predetermined dose in the protocol via IV) * High-dose Trastuzumab weekly for the first 24 weeks, and thereafter trastuzumab q3w). ATEZOLIZUMAB: (IV) every 3 weeks PERTUZUMAB: Loading dose, followed every 3 weeks thereafter by a predetermined dose in the protocol via IV TRASTUZUMAB: Predetermined dose per protocol via IV, weekly for 24 weeks and after every 3 weeks
Overall Study STARTED	19
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Atezolizumab + Pertuzumab + Trastuzumab In CNS Mets In BC

Baseline characteristics by cohort

Measure	ATEZOLIZUMAB, PERTUZUMAB, TRASTUZUMAB n=19 Participants Patients will receive the following treatment: * Atezolizumab (IV) every 3 weeks (q3w)\] * Pertuzumab (loading dose ), followed q3w thereafter by a predetermined dose in the protocol via IV) * High-dose Trastuzumab weekly for the first 24 weeks, and thereafter trastuzumab q3w). ATEZOLIZUMAB: (IV) every 3 weeks PERTUZUMAB: Loading dose, followed every 3 weeks thereafter by a predetermined dose in the protocol via IV TRASTUZUMAB: Predetermined dose per protocol via IV, weekly for 24 weeks and after every 3 weeks
Age, Continuous	50 years n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
ECOG PS 0	12 Participants n=5 Participants
ECOG PS 1	7 Participants n=5 Participants
Stage at Initial Diagnosis I	1 Participants n=5 Participants
Stage at Initial Diagnosis II	5 Participants n=5 Participants
Stage at Initial Diagnosis III	5 Participants n=5 Participants
Stage at Initial Diagnosis IV	5 Participants n=5 Participants
Stage at Initial Diagnosis Not IV, but otherwise unknown	3 Participants n=5 Participants
Hormone Receptor Status of Primary Tumor ER and PR positive	7 Participants n=5 Participants
Hormone Receptor Status of Primary Tumor ER positive/PR negative	2 Participants n=5 Participants
Hormone Receptor Status of Primary Tumor ER negative/PR positive	1 Participants n=5 Participants
Hormone Receptor Status of Primary Tumor ER and PR negative	9 Participants n=5 Participants
Hormone Receptor Status of Metastatic Tumor ER and PR positive	1 Participants n=5 Participants
Hormone Receptor Status of Metastatic Tumor ER positive/PR negative	2 Participants n=5 Participants
Hormone Receptor Status of Metastatic Tumor ER negative/PR positive	1 Participants n=5 Participants
Hormone Receptor Status of Metastatic Tumor ER and PR negative	10 Participants n=5 Participants
Hormone Receptor Status of Metastatic Tumor Unknown	5 Participants n=5 Participants
HER-2 Status of Primary Tumor (IHC) Negative (0,1+)	2 Participants n=5 Participants
HER-2 Status of Primary Tumor (IHC) Equivocal (2+)	0 Participants n=5 Participants
HER-2 Status of Primary Tumor (IHC) Positive (3+)	13 Participants n=5 Participants
HER-2 Status of Primary Tumor (IHC) Not Done	4 Participants n=5 Participants
HER-2 Status of Primary Tumor (FISH) Equivocal (4<= copy number <6 and HER2/CEP17 ratio <2.0)	1 Participants n=5 Participants
HER-2 Status of Primary Tumor (FISH) Positive (copy number >=6 or HER2/CEP17 ratio >=2.0)	8 Participants n=5 Participants
HER-2 Status of Primary Tumor (FISH) Not Done	10 Participants n=5 Participants
Measurable Disease by RECIST 1.1 Yes	7 Participants n=5 Participants
Measurable Disease by RECIST 1.1 No	12 Participants n=5 Participants
Tissue Available at Baseline Yes	17 Participants n=5 Participants
Tissue Available at Baseline No	2 Participants n=5 Participants
Sites of Disease at Study Entry Breast or chest wall	18 Participants n=5 Participants
Sites of Disease at Study Entry Other	1 Participants n=5 Participants
Lines of Chemotherapy for Metastasis or Recurrence None	1 Participants n=5 Participants
Lines of Chemotherapy for Metastasis or Recurrence 1 line	4 Participants n=5 Participants
Lines of Chemotherapy for Metastasis or Recurrence 2 lines	6 Participants n=5 Participants
Lines of Chemotherapy for Metastasis or Recurrence > 2 lines	8 Participants n=5 Participants
Use of Corticosteroids Yes	5 Participants n=5 Participants
Use of Corticosteroids No	14 Participants n=5 Participants
Prior Brain Surgery Yes	6 Participants n=5 Participants
Prior Brain Surgery No	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: Participants were evaluated for response every 6 weeks for the first 24 weeks and then every 9 weeks thereafter, through study completion, an average of 24 weeks in the real study data

The proportion of patients who had confirmed complete response or confirmed partial response, assessed using neuro-oncology-brain metastases (RANO-BM) criteria. RANO-BM assess the response of brain metastases to treatment, using MRI scan. There are four categories as results: Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD), which is separately defined as disappearance of all target lesions, at least a 30% decrease in the sum of the diameters of target lesions, neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as progressive disease (PD) and at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest) or the appearance of one or more new lesions.

Outcome measures

Measure

ATEZOLIZUMAB, PERTUZUMAB, TRASTUZUMAB n=19 Participants Patients will receive the following treatment: * Atezolizumab (IV) every 3 weeks (q3w)\] * Pertuzumab (loading dose ), followed q3w thereafter by a predetermined dose in the protocol via IV) * High-dose Trastuzumab weekly for the first 24 weeks, and thereafter trastuzumab q3w). ATEZOLIZUMAB: (IV) every 3 weeks PERTUZUMAB: Loading dose, followed every 3 weeks thereafter by a predetermined dose in the protocol via IV TRASTUZUMAB: Predetermined dose per protocol via IV, weekly for 24 weeks and after every 3 weeks

Confirmed Overall Response Rate in CNS

2 Participants

SECONDARY outcome

Timeframe: Participants were evaluated for response every 6 weeks for the first 24 weeks and then every 9 weeks thereafter, through study completion, an average of 24 weeks in the real study data

The proportion of patients who had confirmed complete response or partial response, according to response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria. RECIST is used to assess the response of solid tumors to treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.

Outcome measures

Measure

ATEZOLIZUMAB, PERTUZUMAB, TRASTUZUMAB n=19 Participants Patients will receive the following treatment: * Atezolizumab (IV) every 3 weeks (q3w)\] * Pertuzumab (loading dose ), followed q3w thereafter by a predetermined dose in the protocol via IV) * High-dose Trastuzumab weekly for the first 24 weeks, and thereafter trastuzumab q3w). ATEZOLIZUMAB: (IV) every 3 weeks PERTUZUMAB: Loading dose, followed every 3 weeks thereafter by a predetermined dose in the protocol via IV TRASTUZUMAB: Predetermined dose per protocol via IV, weekly for 24 weeks and after every 3 weeks

Objective Non-CNS Response Rates

1 Participants

SECONDARY outcome

Timeframe: Participants were evaluated for response every 6 weeks for the first 24 weeks and then every 9 weeks thereafter, through study completion, an average of 24 weeks in the real study data

The proportion of patients who had stable disease, confirmed partial response or complete response, respectively, >=18 weeks, according to RANO-BM criteria

Outcome measures

Measure

ATEZOLIZUMAB, PERTUZUMAB, TRASTUZUMAB n=19 Participants Patients will receive the following treatment: * Atezolizumab (IV) every 3 weeks (q3w)\] * Pertuzumab (loading dose ), followed q3w thereafter by a predetermined dose in the protocol via IV) * High-dose Trastuzumab weekly for the first 24 weeks, and thereafter trastuzumab q3w). ATEZOLIZUMAB: (IV) every 3 weeks PERTUZUMAB: Loading dose, followed every 3 weeks thereafter by a predetermined dose in the protocol via IV TRASTUZUMAB: Predetermined dose per protocol via IV, weekly for 24 weeks and after every 3 weeks

Clinical Benefit Rate in CNS at 18 Weeks

8 Participants

SECONDARY outcome

Timeframe: 24 weeks

Population: We only report the SSS and SIS scores that are available and stratified by with or without CBR at 18 weeks, thus the sample size in different categories differ from the overall sample size

Evaluated by M.D. Anderson Symptom Inventory Brain Tumor (MDASI-BT). MDASI-BT assess 13 symptom items and 6 interference items from the core MDAST as well as 9 symptoms specific to brain tumors, and generate Symptom Severity Score (SSS) and Symptom Interference Score (SIS) separately. The scale of the scores are in a range of 0 to 10, where 0 represents "not present" or "not severe," and 10 represents "as bad as you can imagine" or "most severe." A higher score indicates a higher level of symptom severity.

Mean of the scores are reported across groups with and without CBR at 18 weeks and in baseline, week 9 and week 24.

Outcome measures

Measure	ATEZOLIZUMAB, PERTUZUMAB, TRASTUZUMAB n=18 Participants Patients will receive the following treatment: * Atezolizumab (IV) every 3 weeks (q3w)\] * Pertuzumab (loading dose ), followed q3w thereafter by a predetermined dose in the protocol via IV) * High-dose Trastuzumab weekly for the first 24 weeks, and thereafter trastuzumab q3w). ATEZOLIZUMAB: (IV) every 3 weeks PERTUZUMAB: Loading dose, followed every 3 weeks thereafter by a predetermined dose in the protocol via IV TRASTUZUMAB: Predetermined dose per protocol via IV, weekly for 24 weeks and after every 3 weeks
Patient Reported Outcomes by MDASI-BT Stratified by CBR at 18 Weeks SSS Score for patients without CBR at 18 weeks at Baseline	1.9 score on a scale Standard Deviation 1.2
Patient Reported Outcomes by MDASI-BT Stratified by CBR at 18 Weeks SSS Score for patients without CBR at 18 weeks at Week 9	1.9 score on a scale Standard Deviation 1.1
Patient Reported Outcomes by MDASI-BT Stratified by CBR at 18 Weeks SIS Score for patients with CBR at 18 weeks at Week 9	2.8 score on a scale Standard Deviation 2.6
Patient Reported Outcomes by MDASI-BT Stratified by CBR at 18 Weeks SIS Score for patients without CBR at 18 weeks at Week 9	2.4 score on a scale Standard Deviation 2.4
Patient Reported Outcomes by MDASI-BT Stratified by CBR at 18 Weeks SSS Score for patients with CBR at 18 weeks at Baseline	1.8 score on a scale Standard Deviation 1.2
Patient Reported Outcomes by MDASI-BT Stratified by CBR at 18 Weeks SSS Score for patients with CBR at 18 weeks at Week 9	1.5 score on a scale Standard Deviation 0.9
Patient Reported Outcomes by MDASI-BT Stratified by CBR at 18 Weeks SSS Score for patients with CBR at 18 weeks at Week 24	1.7 score on a scale Standard Deviation 1.3
Patient Reported Outcomes by MDASI-BT Stratified by CBR at 18 Weeks SSS Score for patients without CBR at 18 weeks at Week 24	2.5 score on a scale Standard Deviation 1.4
Patient Reported Outcomes by MDASI-BT Stratified by CBR at 18 Weeks SIS Score for patients with CBR at 18 weeks at Baseline	4.0 score on a scale Standard Deviation 2.3
Patient Reported Outcomes by MDASI-BT Stratified by CBR at 18 Weeks SIS Score for patients with CBR at 18 weeks at Week 24	2.6 score on a scale Standard Deviation 3.4
Patient Reported Outcomes by MDASI-BT Stratified by CBR at 18 Weeks SIS Score for patients without CBR at 18 weeks at Baseline	2.2 score on a scale Standard Deviation 2.1
Patient Reported Outcomes by MDASI-BT Stratified by CBR at 18 Weeks SIS Score for patients without CBR at 18 weeks at Week 24	4.2 score on a scale Standard Deviation 2.9

SECONDARY outcome

Timeframe: 24 weeks

Population: We only report the EQ-5D scores that are available and stratified by with or without CBR at 18 weeks, thus the sample size in different categories differ from the overall sample size

Evaluated by EuroQol Five Dimension Questionnaire (EQ-5D) evaluations assessments to assess the general health status of patients enrolled in the study. EQ-5D scores are assessed with five dimensions with the range of 0 to 5, and a higher score indicates worse health.

Mean of the scores are reported across groups with and without CBR at 18 weeks and in baseline, week 9 and week 24.

Outcome measures

Measure	ATEZOLIZUMAB, PERTUZUMAB, TRASTUZUMAB n=18 Participants Patients will receive the following treatment: * Atezolizumab (IV) every 3 weeks (q3w)\] * Pertuzumab (loading dose ), followed q3w thereafter by a predetermined dose in the protocol via IV) * High-dose Trastuzumab weekly for the first 24 weeks, and thereafter trastuzumab q3w). ATEZOLIZUMAB: (IV) every 3 weeks PERTUZUMAB: Loading dose, followed every 3 weeks thereafter by a predetermined dose in the protocol via IV TRASTUZUMAB: Predetermined dose per protocol via IV, weekly for 24 weeks and after every 3 weeks
Patient Reported Outcomes by EQ-5D Stratified by CBR at 18 Weeks Patients with CBR at 18 weeks at Baseline	0.7 units on a scale Standard Deviation 0.5
Patient Reported Outcomes by EQ-5D Stratified by CBR at 18 Weeks Patients without CBR at 18 weeks at Week 9	0.8 units on a scale Standard Deviation 0.4
Patient Reported Outcomes by EQ-5D Stratified by CBR at 18 Weeks Patients without CBR at 18 weeks at Week 24	1.4 units on a scale Standard Deviation 0.7
Patient Reported Outcomes by EQ-5D Stratified by CBR at 18 Weeks Patients with CBR at 18 weeks at Week 9	0.5 units on a scale Standard Deviation 0.4
Patient Reported Outcomes by EQ-5D Stratified by CBR at 18 Weeks Patients with CBR at 18 weeks at Week 24	0.7 units on a scale Standard Deviation 0.9
Patient Reported Outcomes by EQ-5D Stratified by CBR at 18 Weeks Patients without CBR at 18 weeks at Baseline	0.9 units on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: 24 weeks

Population: We only report the NANO scores that are available and stratified by with or without CBR at 18 weeks, thus the sample size in different categories differ from the overall sample size

Evaluated by physician assessed Neurological Assessment in Neuro-Oncology (NANO) scale. The NANO scale is a quantifiable evaluation of 9 relevant neurologic domains based on direct observation and testing conducted during visits. The score defines overall response criteria and is with the range of 0 to 4. Higher score means worse response to the treatment.

Mean of the scores are reported across groups with and without CBR at 18 weeks and in baseline, week 9 and week 24.

Outcome measures

Measure	ATEZOLIZUMAB, PERTUZUMAB, TRASTUZUMAB n=18 Participants Patients will receive the following treatment: * Atezolizumab (IV) every 3 weeks (q3w)\] * Pertuzumab (loading dose ), followed q3w thereafter by a predetermined dose in the protocol via IV) * High-dose Trastuzumab weekly for the first 24 weeks, and thereafter trastuzumab q3w). ATEZOLIZUMAB: (IV) every 3 weeks PERTUZUMAB: Loading dose, followed every 3 weeks thereafter by a predetermined dose in the protocol via IV TRASTUZUMAB: Predetermined dose per protocol via IV, weekly for 24 weeks and after every 3 weeks
Investigator-Assessed Neurological Evaluation (NANO) Stratified by CBR at 18 Weeks Patients with CBR at 18 weeks at Baseline	0.03 units on a scale Standard Deviation 0.08
Investigator-Assessed Neurological Evaluation (NANO) Stratified by CBR at 18 Weeks Patients with CBR at 18 weeks at Week 9	0.1 units on a scale Standard Deviation 0.13
Investigator-Assessed Neurological Evaluation (NANO) Stratified by CBR at 18 Weeks Patients with CBR at 18 weeks at Week 24	0.17 units on a scale Standard Deviation 0.27
Investigator-Assessed Neurological Evaluation (NANO) Stratified by CBR at 18 Weeks Patients without CBR at 18 weeks at Baseline	0.1 units on a scale Standard Deviation 0.14
Investigator-Assessed Neurological Evaluation (NANO) Stratified by CBR at 18 Weeks Patients without CBR at 18 weeks at Week 9	0.18 units on a scale Standard Deviation 0.24
Investigator-Assessed Neurological Evaluation (NANO) Stratified by CBR at 18 Weeks Patients without CBR at 18 weeks at Week 24	0.39 units on a scale Standard Deviation 0.27

SECONDARY outcome

Timeframe: Participants were evaluated for response every 6 weeks for the first 24 weeks and then every 9 weeks thereafter, through study completion, an average of 24 weeks in the real study data

The proportion of patients who had stable disease, confirmed partial response or complete response, respectively, >=24 weeks, according to RANO-BM criteria

Outcome measures

Measure

ATEZOLIZUMAB, PERTUZUMAB, TRASTUZUMAB n=19 Participants Patients will receive the following treatment: * Atezolizumab (IV) every 3 weeks (q3w)\] * Pertuzumab (loading dose ), followed q3w thereafter by a predetermined dose in the protocol via IV) * High-dose Trastuzumab weekly for the first 24 weeks, and thereafter trastuzumab q3w). ATEZOLIZUMAB: (IV) every 3 weeks PERTUZUMAB: Loading dose, followed every 3 weeks thereafter by a predetermined dose in the protocol via IV TRASTUZUMAB: Predetermined dose per protocol via IV, weekly for 24 weeks and after every 3 weeks

Clinical Benefit Rate in CNS at 24 Weeks

6 Participants

Adverse Events

ATEZOLIZUMAB, PERTUZUMAB, TRASTUZUMAB

Serious events: 10 serious events

Other events: 19 other events

Deaths: 1 deaths

Serious adverse events

Measure	ATEZOLIZUMAB, PERTUZUMAB, TRASTUZUMAB n=19 participants at risk Patients will receive the following treatment: * Atezolizumab (IV) every 3 weeks (q3w)\] * Pertuzumab (loading dose ), followed q3w thereafter by a predetermined dose in the protocol via IV) * High-dose Trastuzumab weekly for the first 24 weeks, and thereafter trastuzumab q3w). ATEZOLIZUMAB: (IV) every 3 weeks PERTUZUMAB: Loading dose, followed every 3 weeks thereafter by a predetermined dose in the protocol via IV TRASTUZUMAB: Predetermined dose per protocol via IV, weekly for 24 weeks and after every 3 weeks
Blood and lymphatic system disorders Anemia	15.8% 3/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Cardiac disorders Heart failure	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Gastrointestinal disorders Abdominal pain	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Gastrointestinal disorders Diarrhea	10.5% 2/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
General disorders Other	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
General disorders Fatigue	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Hepatobiliary disorders Portal vein thrombosis	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Infections and infestations Urinary tract infection	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Investigations Lymphocyte count decreased	10.5% 2/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Investigations Platelet count decreased	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Investigations Weight loss	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Metabolism and nutrition disorders Hyperglycemia	10.5% 2/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Metabolism and nutrition disorders Hypokalemia	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Nervous system disorders Edema cerebral	10.5% 2/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Nervous system disorders Headache	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Nervous system disorders Seizure	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Psychiatric disorders Confusion	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Skin and subcutaneous tissue disorders Rash maculo-papular	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Vascular disorders Hypertension	10.5% 2/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Vascular disorders Thromboembolic event	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.

Other adverse events

Measure	ATEZOLIZUMAB, PERTUZUMAB, TRASTUZUMAB n=19 participants at risk Patients will receive the following treatment: * Atezolizumab (IV) every 3 weeks (q3w)\] * Pertuzumab (loading dose ), followed q3w thereafter by a predetermined dose in the protocol via IV) * High-dose Trastuzumab weekly for the first 24 weeks, and thereafter trastuzumab q3w). ATEZOLIZUMAB: (IV) every 3 weeks PERTUZUMAB: Loading dose, followed every 3 weeks thereafter by a predetermined dose in the protocol via IV TRASTUZUMAB: Predetermined dose per protocol via IV, weekly for 24 weeks and after every 3 weeks
Blood and lymphatic system disorders Anemia	26.3% 5/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Blood and lymphatic system disorders Lymph node pain	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Cardiac disorders Cardiac disorders - Other, specify	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Cardiac disorders Sinus bradycardia	10.5% 2/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Cardiac disorders Sinus tachycardia	10.5% 2/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Ear and labyrinth disorders Ear pain	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Ear and labyrinth disorders Tinnitus	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Endocrine disorders Endocrine disorders - Other, specify	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Endocrine disorders Hyperthyroidism	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Endocrine disorders Hypothyroidism	26.3% 5/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Eye disorders Blurred vision	10.5% 2/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Eye disorders Dry eye	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Eye disorders Eye disorders - Other, specify	10.5% 2/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Eye disorders Optic nerve disorder	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Gastrointestinal disorders Abdominal pain	10.5% 2/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Gastrointestinal disorders Bloating	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Gastrointestinal disorders Colitis	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Gastrointestinal disorders Constipation	36.8% 7/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Gastrointestinal disorders Diarrhea	57.9% 11/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Gastrointestinal disorders Dry mouth	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Gastrointestinal disorders Dyspepsia	15.8% 3/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Gastrointestinal disorders Dysphagia	10.5% 2/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Gastrointestinal disorders Fecal incontinence	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Gastrointestinal disorders Flatulence	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Gastrointestinal disorders Gastric ulcer	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Gastrointestinal disorders Nausea	52.6% 10/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Gastrointestinal disorders Vomiting	31.6% 6/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
General disorders Chills	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
General disorders Edema limbs	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
General disorders Fatigue	84.2% 16/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
General disorders Fever	10.5% 2/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
General disorders Gait disturbance	26.3% 5/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
General disorders Malaise	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
General disorders Pain	31.6% 6/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Immune system disorders Immune system disorders - Other, specify	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Infections and infestations Infections and infestations - Other, specify	10.5% 2/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Infections and infestations Lung infection	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Infections and infestations Papulopustular rash	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Infections and infestations Paronychia	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Infections and infestations Urinary tract infection	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Infections and infestations Vaginal infection	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Injury, poisoning and procedural complications Bruising	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Injury, poisoning and procedural complications Fall	26.3% 5/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specify	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Investigations Activated partial thromboplastin time prolonged	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Investigations Alanine aminotransferase increased	15.8% 3/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Investigations Alkaline phosphatase increased	21.1% 4/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Investigations Aspartate aminotransferase increased	47.4% 9/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Investigations Blood bilirubin increased	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Investigations Creatinine increased	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Investigations Ejection fraction decreased	10.5% 2/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Investigations Lymphocyte count decreased	36.8% 7/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Investigations Neutrophil count decreased	15.8% 3/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Investigations Platelet count decreased	15.8% 3/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Investigations Weight gain	21.1% 4/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Investigations Weight loss	15.8% 3/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Investigations White blood cell decreased	21.1% 4/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Metabolism and nutrition disorders Anorexia	21.1% 4/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Metabolism and nutrition disorders Dehydration	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Metabolism and nutrition disorders Hyperglycemia	42.1% 8/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Metabolism and nutrition disorders Hypoalbuminemia	31.6% 6/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Metabolism and nutrition disorders Hypocalcemia	21.1% 4/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Metabolism and nutrition disorders Hypokalemia	15.8% 3/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Metabolism and nutrition disorders Hyponatremia	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	15.8% 3/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Musculoskeletal and connective tissue disorders Arthralgia	26.3% 5/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Musculoskeletal and connective tissue disorders Arthritis	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Musculoskeletal and connective tissue disorders Back pain	21.1% 4/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Musculoskeletal and connective tissue disorders Bone pain	10.5% 2/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	21.1% 4/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Musculoskeletal and connective tissue disorders Muscle weakness left-sided	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Musculoskeletal and connective tissue disorders Myalgia	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Musculoskeletal and connective tissue disorders Neck pain	10.5% 2/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Nervous system disorders Ataxia	26.3% 5/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Nervous system disorders Cognitive disturbance	15.8% 3/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Nervous system disorders Concentration impairment	10.5% 2/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Nervous system disorders Dizziness	21.1% 4/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Nervous system disorders Dysarthria	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Nervous system disorders Dysesthesia	10.5% 2/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Nervous system disorders Facial muscle weakness	10.5% 2/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Nervous system disorders Headache	57.9% 11/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Nervous system disorders Memory impairment	21.1% 4/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Nervous system disorders Nervous system disorders - Other, specify	10.5% 2/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Nervous system disorders Paresthesia	10.5% 2/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Nervous system disorders Peripheral motor neuropathy	15.8% 3/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Nervous system disorders Peripheral sensory neuropathy	21.1% 4/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Nervous system disorders Seizure	10.5% 2/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Nervous system disorders Somnolence	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Nervous system disorders Spasticity	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Nervous system disorders Tremor	15.8% 3/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Psychiatric disorders Anxiety	26.3% 5/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Psychiatric disorders Confusion	10.5% 2/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Psychiatric disorders Depression	26.3% 5/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Psychiatric disorders Insomnia	21.1% 4/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Psychiatric disorders Mania	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Psychiatric disorders Suicidal ideation	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Renal and urinary disorders Acute kidney injury	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Renal and urinary disorders Chronic kidney disease	10.5% 2/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Renal and urinary disorders Proteinuria	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Renal and urinary disorders Renal and urinary disorders - Other, specify	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Renal and urinary disorders Urinary frequency	10.5% 2/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Renal and urinary disorders Urinary retention	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Renal and urinary disorders Urinary tract pain	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Renal and urinary disorders Urine discoloration	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Reproductive system and breast disorders Dyspareunia	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Reproductive system and breast disorders Reproductive system and breast disorders - Other, specify	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	15.8% 3/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Respiratory, thoracic and mediastinal disorders Cough	36.8% 7/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Respiratory, thoracic and mediastinal disorders Dyspnea	15.8% 3/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Respiratory, thoracic and mediastinal disorders Epistaxis	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Respiratory, thoracic and mediastinal disorders Hoarseness	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Respiratory, thoracic and mediastinal disorders Nasal congestion	10.5% 2/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Respiratory, thoracic and mediastinal disorders Pleural effusion	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Respiratory, thoracic and mediastinal disorders Pneumonitis	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Respiratory, thoracic and mediastinal disorders Postnasal drip	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Respiratory, thoracic and mediastinal disorders Sore throat	21.1% 4/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Skin and subcutaneous tissue disorders Alopecia	21.1% 4/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Skin and subcutaneous tissue disorders Erythema multiforme	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Skin and subcutaneous tissue disorders Pain of skin	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Skin and subcutaneous tissue disorders Pruritus	10.5% 2/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Skin and subcutaneous tissue disorders Rash acneiform	10.5% 2/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Skin and subcutaneous tissue disorders Rash maculo-papular	10.5% 2/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Skin and subcutaneous tissue disorders Skin/subcutaneous tissue disorders; Other, specify	15.8% 3/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Vascular disorders Hypertension	47.4% 9/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Vascular disorders Hypotension	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Vascular disorders Lymphedema	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.
Vascular disorders Thromboembolic event	5.3% 1/19 • All adverse events were reported after initiation of study treatment and until 30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, an average of one and a half years Serious Adverse Events are defined as any events with grade 3 or higher. Other Adverse Events include any grade 1 and 2 events and those exceed 5% frequency threshold are reported.

Additional Information

Nancy Lin, MD

Dana-Farber Cancer Institute

Phone: 617-632-3800

Email: Nancy_Lin@dfci.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place