Trial Outcomes & Findings for Carboplatin Plus Pemetrexed Plus Atezolizumab Plus Bevacizumab in Chemotherapy and Immunotherapy-naïve Patients With Stage IV Non-squamous Non-small Cell Lung Cancer (NCT NCT03713944)

Last Updated: 2023-03-01

Results Overview

Progression free survival (PFS) defined as the time from the initiation of treatment to the time when the criteria for disease progression is met as defined by RECIST v1.1 or death of any cause.Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

From C1D1 until progression or death up to maximum of 20 Months

Results posted on

2023-03-01

Participant Flow

Participant milestones

Participant milestones
Measure	Arm A: Carboplatin + Pemetrexed + Atezolizumab + Bevacizumab Carboplatin (AUC 5) i.v. day 1 plus pemetrexed (500 mg/m2) i.v. day 1 plus atezolizumab 1200 mg i.v. day 1 plus bevacizumab 15 mg/kg i.v. day 1 every 3 weeks for up to 4 cycles. Patients with non-PD after 4 cycles will be permitted to continue with maintenance therapy with pemetrexed plus atezolizumab plus bevacizumab every 3 weeks until the time of disease progression or intolerable toxicities. Carboplatin: Carboplatin, AUC 5 Pemetrexed: Pemetrexed 500mg/m2 Atezolizumab: Atezolizumab 1200mg Bevacizumab: Bevacizumab 15mg/kg
Study Treatment STARTED	30
Study Treatment COMPLETED	0
Study Treatment NOT COMPLETED	30
Follow up STARTED	30
Follow up COMPLETED	14
Follow up NOT COMPLETED	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A: Carboplatin + Pemetrexed + Atezolizumab + Bevacizumab Carboplatin (AUC 5) i.v. day 1 plus pemetrexed (500 mg/m2) i.v. day 1 plus atezolizumab 1200 mg i.v. day 1 plus bevacizumab 15 mg/kg i.v. day 1 every 3 weeks for up to 4 cycles. Patients with non-PD after 4 cycles will be permitted to continue with maintenance therapy with pemetrexed plus atezolizumab plus bevacizumab every 3 weeks until the time of disease progression or intolerable toxicities. Carboplatin: Carboplatin, AUC 5 Pemetrexed: Pemetrexed 500mg/m2 Atezolizumab: Atezolizumab 1200mg Bevacizumab: Bevacizumab 15mg/kg
Study Treatment Patient non-compliance	1
Study Treatment Alternative Cancer Therapy	3
Study Treatment Disease Progression	18
Study Treatment AE/Side Effects/Complications	2
Study Treatment Death	2
Study Treatment Withdrawal by Subject	1
Study Treatment Subject decided to come off study due to hip replacement	1
Study Treatment Symptomatic Deterioration	2
Follow up Withdrawal by Subject	2
Follow up Death	11
Follow up Study Terminated	3

Baseline Characteristics

Carboplatin Plus Pemetrexed Plus Atezolizumab Plus Bevacizumab in Chemotherapy and Immunotherapy-naïve Patients With Stage IV Non-squamous Non-small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A: Carboplatin + Pemetrexed + Atezolizumab + Bevacizumab n=30 Participants Carboplatin (AUC 5) i.v. day 1 plus pemetrexed (500 mg/m2) i.v. day 1 plus atezolizumab 1200 mg i.v. day 1 plus bevacizumab 15 mg/kg i.v. day 1 every 3 weeks for up to 4 cycles. Patients with non-PD after 4 cycles will be permitted to continue with maintenance therapy with pemetrexed plus atezolizumab plus bevacizumab every 3 weeks until the time of disease progression or intolerable toxicities. Carboplatin: Carboplatin, AUC 5 Pemetrexed: Pemetrexed 500mg/m2 Atezolizumab: Atezolizumab 1200mg Bevacizumab: Bevacizumab 15mg/kg
Age, Continuous	64 years n=99 Participants
Sex/Gender, Customized Gender · Female	20 Participants n=99 Participants
Sex/Gender, Customized Gender · Male	10 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race/Ethnicity, Customized RACE · Asian	3 Participants n=99 Participants
Race/Ethnicity, Customized RACE · Black or African American	5 Participants n=99 Participants
Race/Ethnicity, Customized RACE · Multiple (White and Asian)	1 Participants n=99 Participants
Race/Ethnicity, Customized RACE · Unknown	1 Participants n=99 Participants
Race/Ethnicity, Customized RACE · White	20 Participants n=99 Participants
Disease Status at Study Entry Recurrent Disease	3 Participants n=99 Participants
Disease Status at Study Entry Stage IV	27 Participants n=99 Participants
PD-L1 Expression Category(Dako 22C3) <1 %	8 Participants n=99 Participants
PD-L1 Expression Category(Dako 22C3) 1-49 %	15 Participants n=99 Participants
PD-L1 Expression Category(Dako 22C3) >=50 %	7 Participants n=99 Participants
Primary Histology Adenocarcinoma	26 Participants n=99 Participants
Primary Histology NSCLC, NOS	4 Participants n=99 Participants
Smoking Status Former (not actively smoking)	22 Participants n=99 Participants
Smoking Status Never (Less than 100 cigarettes in a lifetime)	8 Participants n=99 Participants
Received chemotherapy previously No	24 Participants n=99 Participants
Received chemotherapy previously Yes	6 Participants n=99 Participants
Baseline ECOG 0	10 Participants n=99 Participants
Baseline ECOG 1	20 Participants n=99 Participants
EGFR Mutation testing done No	2 Participants n=99 Participants
EGFR Mutation testing done Yes	28 Participants n=99 Participants
ALK Mutation testing done No	4 Participants n=99 Participants
ALK Mutation testing done Yes	26 Participants n=99 Participants
ROS-1 Rearrangement testing done No	7 Participants n=99 Participants
ROS-1 Rearrangement testing done Yes	23 Participants n=99 Participants
HER-2 Mutation testing done No	23 Participants n=99 Participants
HER-2 Mutation testing done Yes	7 Participants n=99 Participants
RET Translocation testing done No	12 Participants n=99 Participants
RET Translocation testing done Yes	18 Participants n=99 Participants
MET Mutation testing done No	12 Participants n=99 Participants
MET Mutation testing done Yes	18 Participants n=99 Participants
KRAS Mutation testing done No	9 Participants n=99 Participants
KRAS Mutation testing done Yes	21 Participants n=99 Participants
NTRK Fusion testing done No	16 Participants n=99 Participants
NTRK Fusion testing done Yes	14 Participants n=99 Participants
BRAF Mutation testing done No	5 Participants n=99 Participants
BRAF Mutation testing done Yes	25 Participants n=99 Participants
Tumor Mutational Burden No	23 Participants n=99 Participants
Tumor Mutational Burden Yes	7 Participants n=99 Participants

PRIMARY outcome

Timeframe: From C1D1 until progression or death up to maximum of 20 Months

Outcome measures

Outcome measures
Measure	Arm A n=30 Participants Carboplatin (AUC 5) i.v. day 1 plus pemetrexed (500 mg/m2) i.v. day 1 plus atezolizumab 1200 mg i.v. day 1 plus bevacizumab 15 mg/kg i.v. day 1 every 3 weeks for up to 4 cycles. Patients with non-PD after 4 cycles will be permitted to continue with maintenance therapy with pemetrexed plus atezolizumab plus bevacizumab every 3 weeks until the time of disease progression or intolerable toxicities. Carboplatin: Carboplatin, AUC 5 Pemetrexed: Pemetrexed 500mg/m2 Atezolizumab: Atezolizumab 1200mg Bevacizumab: Bevacizumab 15mg/kg
Progression Free Survival	11.3 months Interval 5.5 to 14.9

SECONDARY outcome

Timeframe: From C1D1 until death or up to a maximum of 28 months.

Population: Two patients died prior to first post-baseline assessments.Therefore, 28 out of 30 subjects are analyzed for this objective.

Overall Response rate will include confirmed complete response (CR) + confirmed partial response (PR), as determined as per RECIST v1.1 criteria and assessed by the local investigator or designee. 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; Overall Response (OR) = CR + PR.

Outcome measures

Outcome measures
Measure	Arm A n=28 Participants Carboplatin (AUC 5) i.v. day 1 plus pemetrexed (500 mg/m2) i.v. day 1 plus atezolizumab 1200 mg i.v. day 1 plus bevacizumab 15 mg/kg i.v. day 1 every 3 weeks for up to 4 cycles. Patients with non-PD after 4 cycles will be permitted to continue with maintenance therapy with pemetrexed plus atezolizumab plus bevacizumab every 3 weeks until the time of disease progression or intolerable toxicities. Carboplatin: Carboplatin, AUC 5 Pemetrexed: Pemetrexed 500mg/m2 Atezolizumab: Atezolizumab 1200mg Bevacizumab: Bevacizumab 15mg/kg
Overall Response Rate	42.9 percentage of participants Interval 24.5 to 62.8

SECONDARY outcome

Timeframe: From C1D1 until death or up to a maximum of 28 months

Population: Two patients died prior to first post-baseline assessments.Therefore, 28 out of 30 subjects are analyzed for this objective.

Disease control rate will include complete response (CR\], partial response (PR), and stable disease (SD), as per RECIST v1.1 criteria.

Outcome measures

Outcome measures
Measure	Arm A n=28 Participants Carboplatin (AUC 5) i.v. day 1 plus pemetrexed (500 mg/m2) i.v. day 1 plus atezolizumab 1200 mg i.v. day 1 plus bevacizumab 15 mg/kg i.v. day 1 every 3 weeks for up to 4 cycles. Patients with non-PD after 4 cycles will be permitted to continue with maintenance therapy with pemetrexed plus atezolizumab plus bevacizumab every 3 weeks until the time of disease progression or intolerable toxicities. Carboplatin: Carboplatin, AUC 5 Pemetrexed: Pemetrexed 500mg/m2 Atezolizumab: Atezolizumab 1200mg Bevacizumab: Bevacizumab 15mg/kg
Disease Control Rate	92.9 percentage of participants Interval 76.5 to 99.1

SECONDARY outcome

Timeframe: From C1D1 up to a maximum of 28 Months or until death

To estimate the overall survival (OS) of carboplatin plus pemetrexed plus atezolizumab plus bevacizumab in immunotherapy and chemotherapy-naïve patients with stage IV non-squamous non-small cell lung cancer.

Outcome measures

Outcome measures
Measure	Arm A n=30 Participants Carboplatin (AUC 5) i.v. day 1 plus pemetrexed (500 mg/m2) i.v. day 1 plus atezolizumab 1200 mg i.v. day 1 plus bevacizumab 15 mg/kg i.v. day 1 every 3 weeks for up to 4 cycles. Patients with non-PD after 4 cycles will be permitted to continue with maintenance therapy with pemetrexed plus atezolizumab plus bevacizumab every 3 weeks until the time of disease progression or intolerable toxicities. Carboplatin: Carboplatin, AUC 5 Pemetrexed: Pemetrexed 500mg/m2 Atezolizumab: Atezolizumab 1200mg Bevacizumab: Bevacizumab 15mg/kg
Overall Survival	22.4 months Interval 15.7 to Upper limit has not been reached.

SECONDARY outcome

Timeframe: From C1D1 up to a maximum of 20 Months or until death

To characterize the toxicity of carboplatin plus pemetrexed plus atezolizumab plus bevacizumab in immunotherapy and chemotherapy-naïve patients with stage IV non-squamous non-small cell lung cancer as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.

Outcome measures

Outcome measures
Measure	Arm A n=30 Participants Carboplatin (AUC 5) i.v. day 1 plus pemetrexed (500 mg/m2) i.v. day 1 plus atezolizumab 1200 mg i.v. day 1 plus bevacizumab 15 mg/kg i.v. day 1 every 3 weeks for up to 4 cycles. Patients with non-PD after 4 cycles will be permitted to continue with maintenance therapy with pemetrexed plus atezolizumab plus bevacizumab every 3 weeks until the time of disease progression or intolerable toxicities. Carboplatin: Carboplatin, AUC 5 Pemetrexed: Pemetrexed 500mg/m2 Atezolizumab: Atezolizumab 1200mg Bevacizumab: Bevacizumab 15mg/kg
Number of Participants With Adverse Events Patient had at least one adverse event of any grade	30 Participants
Number of Participants With Adverse Events Patient had at least one grade 3 or greater adverse event	24 Participants
Number of Participants With Adverse Events Patient had at least one grade 3 or greater treatment related adverse event	19 Participants
Number of Participants With Adverse Events Patient had serious adverse event	12 Participants

Adverse Events

Arm A: Carboplatin + Pemetrexed + Atezolizumab + Bevacizumab

Serious events: 12 serious events

Other events: 30 other events

Deaths: 11 deaths

Serious adverse events

Serious adverse events
Measure	Arm A: Carboplatin + Pemetrexed + Atezolizumab + Bevacizumab n=30 participants at risk Carboplatin (AUC 5) i.v. day 1 plus pemetrexed (500 mg/m2) i.v. day 1 plus atezolizumab 1200 mg i.v. day 1 plus bevacizumab 15 mg/kg i.v. day 1 every 3 weeks for up to 4 cycles. Patients with non-PD after 4 cycles will be permitted to continue with maintenance therapy with pemetrexed plus atezolizumab plus bevacizumab every 3 weeks until the time of disease progression or intolerable toxicities. Carboplatin: Carboplatin, AUC 5 Pemetrexed: Pemetrexed 500mg/m2 Atezolizumab: Atezolizumab 1200mg Bevacizumab: Bevacizumab 15mg/kg
Blood and lymphatic system disorders ANEMIA	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Musculoskeletal and connective tissue disorders BACK PAIN	6.7% 2/30 • Number of events 3 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders COLONIC PERFORATION	3.3% 1/30 • Number of events 2 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Psychiatric disorders CONFUSION	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
General disorders DEATH NOS	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders ESOPHAGEAL STENOSIS	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Injury, poisoning and procedural complications FALL	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders GASTROINTESTINAL DISORDERS - OTHER, SPECIFY	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Cardiac disorders HEART FAILURE	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Metabolism and nutrition disorders HYPERNATREMIA	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Vascular disorders HYPOTENSION	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Respiratory, thoracic and mediastinal disorders HYPOXIA	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders ILEUS	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Cardiac disorders MYOCARDIAL INFARCTION	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders SEIZURE	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations SEPSIS	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations SKIN INFECTION	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Vascular disorders THROMBOEMBOLIC EVENT	6.7% 2/30 • Number of events 2 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations URINARY TRACT INFECTION	3.3% 1/30 • Number of events 2 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Other adverse events

Other adverse events
Measure	Arm A: Carboplatin + Pemetrexed + Atezolizumab + Bevacizumab n=30 participants at risk Carboplatin (AUC 5) i.v. day 1 plus pemetrexed (500 mg/m2) i.v. day 1 plus atezolizumab 1200 mg i.v. day 1 plus bevacizumab 15 mg/kg i.v. day 1 every 3 weeks for up to 4 cycles. Patients with non-PD after 4 cycles will be permitted to continue with maintenance therapy with pemetrexed plus atezolizumab plus bevacizumab every 3 weeks until the time of disease progression or intolerable toxicities. Carboplatin: Carboplatin, AUC 5 Pemetrexed: Pemetrexed 500mg/m2 Atezolizumab: Atezolizumab 1200mg Bevacizumab: Bevacizumab 15mg/kg
Infections and infestations ABDOMINAL INFECTION	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders ABDOMINAL PAIN	10.0% 3/30 • Number of events 4 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Investigations ALANINE AMINOTRANSFERASE INCREASED	26.7% 8/30 • Number of events 16 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Investigations ALKALINE PHOSPHATASE INCREASED	10.0% 3/30 • Number of events 4 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Immune system disorders ALLERGIC REACTION	6.7% 2/30 • Number of events 2 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Respiratory, thoracic and mediastinal disorders ALLERGIC RHINITIS	30.0% 9/30 • Number of events 10 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Skin and subcutaneous tissue disorders ALOPECIA	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Blood and lymphatic system disorders ANEMIA	60.0% 18/30 • Number of events 43 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Metabolism and nutrition disorders ANOREXIA	40.0% 12/30 • Number of events 23 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders ANOSMIA	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Psychiatric disorders ANXIETY	16.7% 5/30 • Number of events 5 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Cardiac disorders AORTIC VALVE DISEASE	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Vascular disorders ARTERIAL THROMBOEMBOLISM	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Musculoskeletal and connective tissue disorders ARTHRALGIA	33.3% 10/30 • Number of events 11 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Musculoskeletal and connective tissue disorders ARTHRITIS	13.3% 4/30 • Number of events 4 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	30.0% 9/30 • Number of events 18 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Cardiac disorders ATRIAL FIBRILLATION	16.7% 5/30 • Number of events 6 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Musculoskeletal and connective tissue disorders BACK PAIN	36.7% 11/30 • Number of events 16 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders BELCHING	6.7% 2/30 • Number of events 2 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders BLOATING	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Blood and lymphatic system disorders BLOOD AND LYMPHATIC SYSTEM DISORDERS	3.3% 1/30 • Number of events 2 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Investigations BLOOD LACTATE DEHYDROGENASE INCREASED	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Musculoskeletal and connective tissue disorders BONE PAIN	6.7% 2/30 • Number of events 3 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Reproductive system and breast disorders BREAST PAIN	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Cardiac disorders CARDIAC DISORDERS	6.7% 2/30 • Number of events 2 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Investigations CARDIAC TROPONIN I INCREASED	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Eye disorders CATARACT	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations CATHETER RELATED INFECTION	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Musculoskeletal and connective tissue disorders CHEST WALL PAIN	6.7% 2/30 • Number of events 3 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
General disorders CHILLS	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Investigations CHOLESTEROL HIGH	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Renal and urinary disorders CHRONIC KIDNEY DISEASE	6.7% 2/30 • Number of events 2 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders COGNITIVE DISTURBANCE	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Psychiatric disorders CONFUSION	6.7% 2/30 • Number of events 5 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations CONJUNCTIVITIS INFECTIVE	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders CONSTIPATION	70.0% 21/30 • Number of events 36 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Respiratory, thoracic and mediastinal disorders COUGH	60.0% 18/30 • Number of events 21 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Investigations CREATININE INCREASED	26.7% 8/30 • Number of events 14 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Metabolism and nutrition disorders DEHYDRATION	23.3% 7/30 • Number of events 11 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Psychiatric disorders DELIRIUM	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders DENTAL CARIES	6.7% 2/30 • Number of events 2 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Psychiatric disorders DEPRESSION	26.7% 8/30 • Number of events 10 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders DIARRHEA	40.0% 12/30 • Number of events 17 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders DIZZINESS	13.3% 4/30 • Number of events 4 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Eye disorders DRY EYE	10.0% 3/30 • Number of events 3 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders DRY MOUTH	3.3% 1/30 • Number of events 2 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Skin and subcutaneous tissue disorders DRY SKIN	6.7% 2/30 • Number of events 2 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders DYSARTHRIA	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders DYSGEUSIA	26.7% 8/30 • Number of events 12 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders DYSPEPSIA	16.7% 5/30 • Number of events 6 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders DYSPHAGIA	6.7% 2/30 • Number of events 2 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Respiratory, thoracic and mediastinal disorders DYSPNEA	56.7% 17/30 • Number of events 21 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Ear and labyrinth disorders EAR PAIN	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
General disorders EDEMA FACE	10.0% 3/30 • Number of events 5 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
General disorders EDEMA LIMBS	36.7% 11/30 • Number of events 27 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
General disorders EDEMA TRUNK	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Endocrine disorders ENDOCRINE DISORDERS	20.0% 6/30 • Number of events 7 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	23.3% 7/30 • Number of events 11 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Reproductive system and breast disorders ERECTILE DYSFUNCTION	6.7% 2/30 • Number of events 2 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders ESOPHAGITIS	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Eye disorders EYE DISORDERS	6.7% 2/30 • Number of events 4 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Eye disorders EYE PAIN	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Injury, poisoning and procedural complications FALL	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
General disorders FATIGUE	90.0% 27/30 • Number of events 65 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
General disorders FEVER	13.3% 4/30 • Number of events 5 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Musculoskeletal and connective tissue disorders FLANK PAIN	10.0% 3/30 • Number of events 5 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders FLATULENCE	6.7% 2/30 • Number of events 2 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Vascular disorders FLUSHING	3.3% 1/30 • Number of events 2 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations FOLLICULITIS	3.3% 1/30 • Number of events 2 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders GASTRITIS	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders GASTROESOPHAGEAL REFLUX DISEASE	30.0% 9/30 • Number of events 10 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders GASTROINTESTINAL DISORDERS	16.7% 5/30 • Number of events 5 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
General disorders GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	16.7% 5/30 • Number of events 13 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
General disorders GENERALIZED EDEMA	6.7% 2/30 • Number of events 2 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Musculoskeletal and connective tissue disorders GENERALIZED MUSCLE WEAKNESS	10.0% 3/30 • Number of events 3 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders GINGIVAL PAIN	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Psychiatric disorders HALLUCINATIONS	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders HEADACHE	33.3% 10/30 • Number of events 18 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Ear and labyrinth disorders HEARING IMPAIRED	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Cardiac disorders HEART FAILURE	13.3% 4/30 • Number of events 4 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Renal and urinary disorders HEMATURIA	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Renal and urinary disorders HEMOGLOBINURIA	6.7% 2/30 • Number of events 2 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders HEMORRHOIDAL HEMORRHAGE	3.3% 1/30 • Number of events 2 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders HEMORRHOIDS	6.7% 2/30 • Number of events 3 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations HERPES SIMPLEX REACTIVATION	3.3% 1/30 • Number of events 2 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Respiratory, thoracic and mediastinal disorders HICCUPS	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Respiratory, thoracic and mediastinal disorders HOARSENESS	10.0% 3/30 • Number of events 4 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Vascular disorders HOT FLASHES	10.0% 3/30 • Number of events 3 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Metabolism and nutrition disorders HYPERCALCEMIA	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Metabolism and nutrition disorders HYPERGLYCEMIA	30.0% 9/30 • Number of events 9 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Metabolism and nutrition disorders HYPERKALEMIA	13.3% 4/30 • Number of events 4 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Metabolism and nutrition disorders HYPERLIPIDEMIA	50.0% 15/30 • Number of events 15 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Vascular disorders HYPERTENSION	80.0% 24/30 • Number of events 68 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Endocrine disorders HYPERTHYROIDISM	20.0% 6/30 • Number of events 7 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Metabolism and nutrition disorders HYPOALBUMINEMIA	16.7% 5/30 • Number of events 13 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Metabolism and nutrition disorders HYPOCALCEMIA	10.0% 3/30 • Number of events 16 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Metabolism and nutrition disorders HYPOKALEMIA	16.7% 5/30 • Number of events 5 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Metabolism and nutrition disorders HYPOMAGNESEMIA	10.0% 3/30 • Number of events 6 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Metabolism and nutrition disorders HYPONATREMIA	23.3% 7/30 • Number of events 8 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Metabolism and nutrition disorders HYPOPHOSPHATEMIA	6.7% 2/30 • Number of events 5 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Vascular disorders HYPOTENSION	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Endocrine disorders HYPOTHYROIDISM	23.3% 7/30 • Number of events 11 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Respiratory, thoracic and mediastinal disorders HYPOXIA	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Immune system disorders IMMUNE SYSTEM DISORDERS	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations INFECTIONS AND INFESTATIONS	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Injury, poisoning and procedural complications INFUSION RELATED REACTION	3.3% 1/30 • Number of events 3 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Psychiatric disorders INSOMNIA	53.3% 16/30 • Number of events 21 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Injury, poisoning and procedural complications INTRAOPERATIVE CARDIAC INJURY	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Investigations INVESTIGATIONS	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Respiratory, thoracic and mediastinal disorders LARYNGEAL HEMORRHAGE	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Blood and lymphatic system disorders LEUKOCYTOSIS	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Investigations LIPASE INCREASED	10.0% 3/30 • Number of events 18 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
General disorders LOCALIZED EDEMA	10.0% 3/30 • Number of events 3 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations LUNG INFECTION	10.0% 3/30 • Number of events 3 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Investigations LYMPHOCYTE COUNT DECREASED	20.0% 6/30 • Number of events 6 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Psychiatric disorders MANIA	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Metabolism and nutrition disorders METABOLISM AND NUTRITION DISORDERS	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Cardiac disorders MITRAL VALVE DISEASE	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders MOVEMENTS INVOLUNTARY	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders MUCOSITIS ORAL	26.7% 8/30 • Number of events 21 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Musculoskeletal and connective tissue disorders MUSCLE CRAMP	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER	16.7% 5/30 • Number of events 9 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Skin and subcutaneous tissue disorders NAIL CHANGES	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Respiratory, thoracic and mediastinal disorders NASAL CONGESTION	6.7% 2/30 • Number of events 2 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders NAUSEA	70.0% 21/30 • Number of events 74 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Musculoskeletal and connective tissue disorders NECK PAIN	3.3% 1/30 • Number of events 2 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)	6.7% 2/30 • Number of events 4 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders NERVOUS SYSTEM DISORDERS	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders NEURALGIA	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Investigations NEUTROPHIL COUNT DECREASED	30.0% 9/30 • Number of events 23 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
General disorders NON-CARDIAC CHEST PAIN	33.3% 10/30 • Number of events 13 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Eye disorders OPTIC NERVE DISORDER	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders ORAL HEMORRHAGE	6.7% 2/30 • Number of events 3 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders ORAL PAIN	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Musculoskeletal and connective tissue disorders OSTEOPOROSIS	10.0% 3/30 • Number of events 3 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations OTITIS EXTERNA	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
General disorders PAIN	36.7% 11/30 • Number of events 34 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	26.7% 8/30 • Number of events 20 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Skin and subcutaneous tissue disorders PAIN OF SKIN	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Cardiac disorders PALPITATIONS	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders PANCREATITIS	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations PAPULOPUSTULAR RASH	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders PARESTHESIA	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations PARONYCHIA	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Cardiac disorders PAROXYSMAL ATRIAL TACHYCARDIA	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Cardiac disorders PERICARDIAL EFFUSION	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Vascular disorders PERIPHERAL ISCHEMIA	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders PERIPHERAL MOTOR NEUROPATHY	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders PERIPHERAL SENSORY NEUROPATHY	30.0% 9/30 • Number of events 18 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Vascular disorders PHLEBITIS	13.3% 4/30 • Number of events 5 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations PHLEBITIS INFECTIVE	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Investigations PLATELET COUNT DECREASED	20.0% 6/30 • Number of events 18 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	13.3% 4/30 • Number of events 5 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Respiratory, thoracic and mediastinal disorders PNEUMONITIS	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Reproductive system and breast disorders PROSTATIC OBSTRUCTION	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Renal and urinary disorders PROTEINURIA	23.3% 7/30 • Number of events 19 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Skin and subcutaneous tissue disorders PRURITUS	20.0% 6/30 • Number of events 11 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Psychiatric disorders PSYCHIATRIC DISORDERS	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Skin and subcutaneous tissue disorders RASH ACNEIFORM	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Skin and subcutaneous tissue disorders RASH MACULO-PAPULAR	16.7% 5/30 • Number of events 10 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders RECTAL HEMORRHAGE	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Renal and urinary disorders RENAL AND URINARY DISORDERS	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Reproductive system and breast disorders REPRODUCTIVE SYSTEM AND BREAST DISORDERS	6.7% 2/30 • Number of events 2 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Respiratory, thoracic and mediastinal disorders RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	16.7% 5/30 • Number of events 6 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Eye disorders RETINAL DETACHMENT	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Eye disorders RETINAL TEAR	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Respiratory, thoracic and mediastinal disorders RHINORRHEA	6.7% 2/30 • Number of events 3 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Skin and subcutaneous tissue disorders SCALP PAIN	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Investigations SERUM AMYLASE INCREASED	20.0% 6/30 • Number of events 10 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations SHINGLES	3.3% 1/30 • Number of events 3 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Cardiac disorders SINUS BRADYCARDIA	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Cardiac disorders SINUS TACHYCARDIA	6.7% 2/30 • Number of events 2 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations SINUSITIS	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Skin and subcutaneous tissue disorders SKIN AND SUBCUTANEOUS TISSUE DISORDERS	13.3% 4/30 • Number of events 6 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Skin and subcutaneous tissue disorders SKIN HYPERPIGMENTATION	6.7% 2/30 • Number of events 2 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations SKIN INFECTION	3.3% 1/30 • Number of events 3 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Skin and subcutaneous tissue disorders SKIN ULCERATION	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Respiratory, thoracic and mediastinal disorders SLEEP APNEA	6.7% 2/30 • Number of events 2 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Injury, poisoning and procedural complications SPINAL FRACTURE	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders STOMACH PAIN	6.7% 2/30 • Number of events 6 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Surgical and medical procedures SURGICAL AND MEDICAL PROCEDURES	6.7% 2/30 • Number of events 2 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders SYNCOPE	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Vascular disorders THROMBOEMBOLIC EVENT	10.0% 3/30 • Number of events 3 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations THRUSH	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Investigations THYROID STIMULATING HORMONE INCREASED	23.3% 7/30 • Number of events 9 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Ear and labyrinth disorders TINNITUS	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders TOOTHACHE	3.3% 1/30 • Number of events 2 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders TREMOR	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Cardiac disorders TRICUSPID VALVE DISEASE	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TUMOR PAIN	10.0% 3/30 • Number of events 4 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations UPPER RESPIRATORY INFECTION	13.3% 4/30 • Number of events 4 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Renal and urinary disorders URINARY FREQUENCY	10.0% 3/30 • Number of events 3 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Renal and urinary disorders URINARY RETENTION	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations URINARY TRACT INFECTION	16.7% 5/30 • Number of events 10 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Reproductive system and breast disorders VAGINAL DRYNESS	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Vascular disorders VASCULAR DISORDERS	10.0% 3/30 • Number of events 4 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Injury, poisoning and procedural complications VENOUS INJURY	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Cardiac disorders VENTRICULAR FIBRILLATION	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Cardiac disorders VENTRICULAR TACHYCARDIA	6.7% 2/30 • Number of events 2 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Ear and labyrinth disorders VERTIGO	6.7% 2/30 • Number of events 2 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders VOMITING	43.3% 13/30 • Number of events 47 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Eye disorders WATERING EYES	13.3% 4/30 • Number of events 6 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Investigations WEIGHT GAIN	20.0% 6/30 • Number of events 10 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Investigations WEIGHT LOSS	33.3% 10/30 • Number of events 16 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Investigations WHITE BLOOD CELL DECREASED	6.7% 2/30 • Number of events 3 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Injury, poisoning and procedural complications WOUND DEHISCENCE	3.3% 1/30 • Number of events 1 • Adverse Events were assessed from C1D1 up to a maximum of 28 Months or until death. All-Cause Mortality was assessed from C1D1 up to a maximum of 28 Months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Additional Information

Annesha Majumdar

Hoosier Cancer Research Network

Phone: 3179212050

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place