Trial Outcomes & Findings for A Study of Avastin (Bevacizumab) Combined With Chemotherapy in Patients With Metastatic Cancer of the Colon or Rectum (NCT NCT01181609)

Last Updated: 2014-07-28

Results Overview

ODC was defined as the percentage of participants with measurable disease at baseline who on assessment achieved complete response (CR), partial response (PR), or stable disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of the longest diameter (LD) of all target lesions. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since start of treatment. CR and PR were confirmed no less than 4 weeks after the criteria for response were met.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

54 participants

Primary outcome timeframe

Baseline, after every other cycle to disease progression or death (Maximum of 52.5 months follow-up)

Results posted on

2014-07-28

Participant Flow

Participant milestones

Participant milestones
Measure	Bevacizumab + Chemotherapy Participants received bevacizumab 2.5 milligrams per kilogram (mg/kg) intravenously (IV) per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
Overall Study STARTED	54
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	53

Reasons for withdrawal

Reasons for withdrawal
Measure	Bevacizumab + Chemotherapy Participants received bevacizumab 2.5 milligrams per kilogram (mg/kg) intravenously (IV) per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
Overall Study Adverse Event	1
Overall Study Withdrawal by Subject	1
Overall Study Lost to Follow-up	1
Overall Study Death	50

Baseline Characteristics

A Study of Avastin (Bevacizumab) Combined With Chemotherapy in Patients With Metastatic Cancer of the Colon or Rectum

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bevacizumab + Chemotherapy n=53 Participants Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
Age, Continuous	60.2 years STANDARD_DEVIATION 11.6 • n=99 Participants
Sex: Female, Male Female	18 Participants n=99 Participants
Sex: Female, Male Male	35 Participants n=99 Participants

PRIMARY outcome

Timeframe: Baseline, after every other cycle to disease progression or death (Maximum of 52.5 months follow-up)

Population: ITT population

Outcome measures

Outcome measures
Measure	Bevacizumab + Chemotherapy n=53 Participants Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
Percentage of Participants Achieving Overall Disease Control (ODC)	87 percentage of participants Interval 77.0 to 97.0

SECONDARY outcome

Timeframe: Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up)

Population: ITT population

Percentage of participants achieving CR or PR as defined by RECIST criteria. CR defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as ≥30% decrease under baseline of the sum of the LD of all target lesions. CR and PR were confirmed no less than 4 weeks after the criteria for response were met.

Outcome measures

Outcome measures
Measure	Bevacizumab + Chemotherapy n=53 Participants Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
Percentage of Participants Achieving a Best Overall Response of CR or PR	32 percentage of participants Interval 19.0 to 46.0

SECONDARY outcome

Timeframe: Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up)

Population: ITT

PFS was defined as the time from start of study treatment to investigator assessed disease progression, or death due to any cause, whichever comes first. Progression was based on tumor assessments made by the investigators according to RECIST.

Outcome measures

Outcome measures
Measure	Bevacizumab + Chemotherapy n=53 Participants Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
Progression-Free Survival (PFS) - Percentage of Participants With an Event	98 percentage of participants

SECONDARY outcome

Timeframe: Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up)

Population: ITT population

Outcome measures

Outcome measures
Measure	Bevacizumab + Chemotherapy n=53 Participants Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
PFS - Time to Event	6.5 months Interval 5.8 to 7.8

SECONDARY outcome

Timeframe: Baseline, every cycle until progression or death (Maximum of 52.5 months follow-up)

Population: ITT population; only participants with a response (CR or PR) were included in the analysis.

Duration of response was defined as the time in months from the day of CR or PR was first noted to the day of progression of disease, death or last follow-up. Median duraiton of response is estimated sing the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Bevacizumab + Chemotherapy n=17 Participants Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
Duration of Response	6 months Interval 4.8 to 7.5

SECONDARY outcome

Timeframe: Baseline, every cycle until progression or death. (Maximum of 52.5 months follow-up)

Population: ITT population; only participants with an ODC response (CR, PR, or SD) were included in the analysis.

ODC duration was defined as the time in months, from when measurement criteria were first met for CR, PR, or SD (whichever status was recorded first) until the first date when progressive disease or the death from any cause was documented. Data were censored for participants who were lost to follow-up, discontinued prematurely without progression/death, or who reached the end of study without progression. Median ODC was estimated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Bevacizumab + Chemotherapy n=46 Participants Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
Duration of Overall Disease Control	6.7 months Interval 5.2 to 7.1

SECONDARY outcome

Timeframe: Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up)

Population: ITT population

Overall survival was defined as the time from start of study treatment to death from any cause.

Outcome measures

Outcome measures
Measure	Bevacizumab + Chemotherapy n=53 Participants Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
Overall Survival (OS) - Percentage of Participants With an Event	93.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline, every cycle to progression or death. (Maximum of 52.5 months follow-up)

Population: ITT population

OS was defined as the time from start of study treatment to death from any cause. Median OS was estimated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Bevacizumab + Chemotherapy n=53 Participants Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
OS - Time to Event	19.3 months 95% Confidence Interval 14,2 • Interval 14.2 to 25.1

Adverse Events

Bevacizumab + Chemotherapy

Serious events: 9 serious events

Other events: 52 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Bevacizumab + Chemotherapy n=53 participants at risk Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
Gastrointestinal disorders Abdominal pain	5.7% 3/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
General disorders Hyperthermia	1.9% 1/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Blood and lymphatic system disorders Febrile neutropenia	1.9% 1/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Infections and infestations Gastroenteritis	1.9% 1/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Renal and urinary disorders Renal failure	1.9% 1/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Renal and urinary disorders Renal pain	1.9% 1/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Surgical and medical procedures Inguinal hernia repair	1.9% 1/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Surgical and medical procedures Radiofrequency ablation	1.9% 1/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Injury, poisoning and procedural complications Humerus fracture	1.9% 1/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Surgical and medical procedures Colonoscopy	1.9% 1/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Musculoskeletal and connective tissue disorders Back pain	1.9% 1/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Psychiatric disorders Cholinergic syndrome	1.9% 1/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Reproductive system and breast disorders Pelvic pain	1.9% 1/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.

Other adverse events

Other adverse events
Measure	Bevacizumab + Chemotherapy n=53 participants at risk Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
Gastrointestinal disorders Nausea	66.0% 35/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Gastrointestinal disorders Diarrhea	60.4% 32/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Gastrointestinal disorders Vomiting	47.2% 25/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Gastrointestinal disorders Abdominal pain	24.5% 13/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Gastrointestinal disorders Constipation	22.6% 12/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Gastrointestinal disorders Abdominal pain upper	15.1% 8/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Gastrointestinal disorders Aphthous stomatitis	9.4% 5/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Gastrointestinal disorders Dyspepsia	9.4% 5/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Gastrointestinal disorders Toothache	7.5% 4/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Gastrointestinal disorders Haemorrhoids	5.7% 3/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
General disorders Asthenia	60.4% 32/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
General disorders Mucosal inflammation	34.0% 18/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
General disorders Fatigue	11.3% 6/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
General disorders Pyrexia	9.4% 5/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Skin and subcutaneous tissue disorders Alopecia	34.0% 18/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	11.3% 6/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Nervous system disorders Paresthesia	24.5% 13/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Nervous system disorders Headache	15.1% 8/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Nervous system disorders Neuropathy	9.4% 5/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Nervous system disorders Dizziness	7.5% 4/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Blood and lymphatic system disorders Neutropenia	30.2% 16/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Blood and lymphatic system disorders Anemia	13.2% 7/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Blood and lymphatic system disorders Thrombocytopenia	7.5% 4/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Musculoskeletal and connective tissue disorders Back pain	7.5% 4/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Musculoskeletal and connective tissue disorders Pain in extremity	9.4% 5/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	5.7% 3/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Musculoskeletal and connective tissue disorders Myalgia	5.7% 3/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Infections and infestations Gastroenteritis	9.4% 5/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Infections and infestations Rhinitis	7.5% 4/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Infections and infestations Nasopharyngitis	5.7% 3/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Metabolism and nutrition disorders Anorexia	24.5% 13/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Respiratory, thoracic and mediastinal disorders Cough	5.7% 3/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Respiratory, thoracic and mediastinal disorders Dyspnea	5.7% 3/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Investigations Weight decreased	7.5% 4/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Psychiatric disorders Anxiety	9.4% 5/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Eye disorders Eye disorder	15.1% 8/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Surgical and medical procedures Surgical and medical procedures	9.4% 5/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	7.5% 4/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Vascular disorders Vascular disorders	5.7% 3/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Hepatobiliary disorders Hepatobiliary disorders	5.7% 3/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Renal and urinary disorders Renal and urinary disorders	5.7% 3/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Vascular disorders Hypertension	41.5% 22/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Respiratory, thoracic and mediastinal disorders Bleeding/hemorrhage (all epistaxis)	54.7% 29/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Gastrointestinal disorders Gastro-intestinal perforation	0.00% 0/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Injury, poisoning and procedural complications Wound healing complication	1.9% 1/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Renal and urinary disorders Proteinuria	11.3% 6/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Vascular disorders Thromboembolism	5.7% 3/53 • Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration. All participants who received at least 1 dose of study treatment were included in the safety analysis population.

Additional Information

Medical Communications

Hoffmann-LaRoche

Phone: 800-821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request the Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER