Trial Outcomes & Findings for Obinutuzumab and Lenalidomide in Treating Patients With Previously Untreated Stage II-IV Grade 1-3a Follicular Lymphoma (NCT NCT02871219)

NCT ID: NCT02871219

Last Updated: 2025-06-08

Results Overview

Will be calculated and corresponding 95% confidence interval (CI) will be derived.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

96 participants

Primary outcome timeframe

approximately 71 months

Results posted on

2025-06-08

Participant Flow

Participant milestones

Participant milestones
Measure	Single Arm Patients receive obinutuzumab IV over 4-6 hours on days 1, 8, and 15 of course 1 and day 1 of cycles 2-6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and 30. Treatment repeats every 28 days for up to 30 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with CR or CRu may receive up to an additional 12 cycles of lenalidomide. Lenalidomide: Given PO Obinutuzumab: Given IV
Overall Study STARTED	90
Overall Study COMPLETED	58
Overall Study NOT COMPLETED	32

Reasons for withdrawal

Reasons for withdrawal
Measure	Single Arm Patients receive obinutuzumab IV over 4-6 hours on days 1, 8, and 15 of course 1 and day 1 of cycles 2-6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and 30. Treatment repeats every 28 days for up to 30 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with CR or CRu may receive up to an additional 12 cycles of lenalidomide. Lenalidomide: Given PO Obinutuzumab: Given IV
Overall Study Adverse Event	15
Overall Study Death	3
Overall Study Progression	3
Overall Study Infections	7
Overall Study Infusion Related	4

Baseline Characteristics

Obinutuzumab and Lenalidomide in Treating Patients With Previously Untreated Stage II-IV Grade 1-3a Follicular Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm n=90 Participants Patients receive obinutuzumab IV over 4-6 hours on days 1, 8, and 15 of course 1 and day 1 of cycles 2-6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and 30. Treatment repeats every 28 days for up to 30 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with CR or CRu may receive up to an additional 12 cycles of lenalidomide. Lenalidomide: Given PO Obinutuzumab: Given IV
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	64 Participants n=99 Participants
Age, Categorical >=65 years	26 Participants n=99 Participants
Sex: Female, Male Female	43 Participants n=99 Participants
Sex: Female, Male Male	47 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	81 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=99 Participants
Race (NIH/OMB) Asian	5 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	4 Participants n=99 Participants
Race (NIH/OMB) White	70 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	10 Participants n=99 Participants
Region of Enrollment United States	90 participants n=99 Participants

PRIMARY outcome

Timeframe: approximately 71 months

Will be calculated and corresponding 95% confidence interval (CI) will be derived.

Outcome measures

Outcome measures
Measure	Single Arm n=90 Participants Patients receive obinutuzumab IV over 4-6 hours on days 1, 8, and 15 of course 1 and day 1 of cycles 2-6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and 30. Treatment repeats every 28 days for up to 30 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with CR or CRu may receive up to an additional 12 cycles of lenalidomide. Lenalidomide: Given PO Obinutuzumab: Given IV
Progression Free Survival	70.7 months Interval 65.8 to 76.1

SECONDARY outcome

Timeframe: 24 months

The number and percentage of subjects will be tabulated.

Outcome measures

Outcome measures
Measure	Single Arm n=90 Participants Patients receive obinutuzumab IV over 4-6 hours on days 1, 8, and 15 of course 1 and day 1 of cycles 2-6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and 30. Treatment repeats every 28 days for up to 30 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with CR or CRu may receive up to an additional 12 cycles of lenalidomide. Lenalidomide: Given PO Obinutuzumab: Given IV
Complete Response	96.6 percentage of participants Interval 90.4 to 99.3

SECONDARY outcome

Timeframe: 24 months

The number and percentage of subjects will be tabulated.

Outcome measures

Outcome measures
Measure	Single Arm n=90 Participants Patients receive obinutuzumab IV over 4-6 hours on days 1, 8, and 15 of course 1 and day 1 of cycles 2-6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and 30. Treatment repeats every 28 days for up to 30 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with CR or CRu may receive up to an additional 12 cycles of lenalidomide. Lenalidomide: Given PO Obinutuzumab: Given IV
Overall Response Rate (CR + Partial Response [PR])	97.70 percentage of participants Interval 92.0 to 99.7

SECONDARY outcome

Timeframe: From the time by which measurement criteria for CR or PR, whichever is recorded first, is met until death or the first date by which progressive disease is documented, assessed up to 3 years

Kaplan-Meier methodology will be used to estimate event-free curves, median, and 95% CI.

Outcome measures

Outcome measures
Measure	Single Arm n=90 Participants Patients receive obinutuzumab IV over 4-6 hours on days 1, 8, and 15 of course 1 and day 1 of cycles 2-6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and 30. Treatment repeats every 28 days for up to 30 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with CR or CRu may receive up to an additional 12 cycles of lenalidomide. Lenalidomide: Given PO Obinutuzumab: Given IV
Duration of Response	NA percentage of participants The DOR was not reached

SECONDARY outcome

Timeframe: From the date of course 1, day 1 to the date of first documented progression, transformation to diffuse large B-cell lymphoma, initiation of new anti-lymphoma treatment, or death, assessed up to 3 years

Kaplan-Meier methodology will be used to estimate event-free curves, median, and 95% CI.

Outcome measures

Outcome measures
Measure	Single Arm n=90 Participants Patients receive obinutuzumab IV over 4-6 hours on days 1, 8, and 15 of course 1 and day 1 of cycles 2-6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and 30. Treatment repeats every 28 days for up to 30 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with CR or CRu may receive up to an additional 12 cycles of lenalidomide. Lenalidomide: Given PO Obinutuzumab: Given IV
Event Free Survival	NA percentage of participants The EFS was not reached

SECONDARY outcome

Timeframe: From the date of course 1, day 1 to the date of death regardless of cause, assessed up to 3 years

Kaplan-Meier methodology will be used to estimate event-free curves, median, and 95% CI.

Outcome measures

Outcome measures
Measure	Single Arm n=90 Participants Patients receive obinutuzumab IV over 4-6 hours on days 1, 8, and 15 of course 1 and day 1 of cycles 2-6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and 30. Treatment repeats every 28 days for up to 30 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with CR or CRu may receive up to an additional 12 cycles of lenalidomide. Lenalidomide: Given PO Obinutuzumab: Given IV
Overall Survival	NA percentage of participants The OS was not reached

Adverse Events

Single Arm

Serious events: 55 serious events

Other events: 87 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Single Arm n=90 participants at risk Patients receive obinutuzumab IV over 4-6 hours on days 1, 8, and 15 of course 1 and day 1 of cycles 2-6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and 30. Treatment repeats every 28 days for up to 30 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with CR or CRu may receive up to an additional 12 cycles of lenalidomide. Lenalidomide: Given PO Obinutuzumab: Given IV
Blood and lymphatic system disorders Blood and lymphatic systmem disorders-Other	2.2% 2/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
General disorders Colitis	3.3% 3/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Gastrointestinal disorders Colonic hemorrhage	1.1% 1/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Respiratory, thoracic and mediastinal disorders Cough	34.4% 31/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Gastrointestinal disorders Diarrhea	61.1% 55/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Nervous system disorders Eye disorders-Other (Basal cell carcinoma (left eye rim)	1.1% 1/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Nervous system disorders Fatigue	47.8% 43/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Blood and lymphatic system disorders Febrile Neutropenia	2.2% 2/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Nervous system disorders Fever	23.3% 21/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Nervous system disorders Headache	22.2% 20/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Vascular disorders Hypercalcemia (Pain in extremity and hypercalcemia)	2.2% 2/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Renal and urinary disorders Hyperuricemia	4.4% 4/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Vascular disorders Hypotension	1.1% 1/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Infections and infestations Infections and infestations-Other	2.2% 2/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Investigations Investigations-Other	13.3% 12/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Investigations Investigation and-Other (Diverticulitis)	1.1% 1/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Respiratory, thoracic and mediastinal disorders Lung Infection (Pneumonia)	7.8% 7/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Blood and lymphatic system disorders Neutrophil count decreased	21.1% 19/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Vascular disorders Paroxysmal atrial tachcardia	1.1% 1/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.2% 2/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	1.1% 1/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Skin and subcutaneous tissue disorders Rash maculo-papular	20.8% 10/48 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders- Other (Pulmonary Embolims)	100.0% 1/1 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Infections and infestations Salivary gland infection	100.0% 1/1 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Respiratory, thoracic and mediastinal disorders Sick sinus syndrome	100.0% 1/1 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Respiratory, thoracic and mediastinal disorders Sinusitis	25.0% 1/4 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Vascular disorders Syncope	100.0% 2/2 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Renal and urinary disorders Treatment related secondary malignancy (Bladder Cancer)	100.0% 2/2 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	4.5% 1/22 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Renal and urinary disorders Urinary tract infection	5.6% 5/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.

Other adverse events

Other adverse events
Measure	Single Arm n=90 participants at risk Patients receive obinutuzumab IV over 4-6 hours on days 1, 8, and 15 of course 1 and day 1 of cycles 2-6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and 30. Treatment repeats every 28 days for up to 30 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with CR or CRu may receive up to an additional 12 cycles of lenalidomide. Lenalidomide: Given PO Obinutuzumab: Given IV
Nervous system disorders Insomnia	8.9% 8/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Nervous system disorders Investigations-Other	10.0% 9/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	1.1% 1/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Blood and lymphatic system disorders Leukocytosis	1.1% 1/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Respiratory, thoracic and mediastinal disorders Lung Infection	4.4% 4/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Infections and infestations Lymphedema	11.1% 10/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Blood and lymphatic system disorders Lymphocyte count decreased	4.4% 4/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Nervous system disorders Memory Impairment	11.1% 10/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Metabolism and nutrition disorders Metabolism and nutrition disorders-Other	2.2% 2/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Investigations Mucositis oral	3.3% 3/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	1.1% 1/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Musculoskeletal and connective tissue disorders Myalgia	45.6% 41/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Blood and lymphatic system disorders Nasal Congestion	5.6% 5/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Gastrointestinal disorders Nausea	30.0% 27/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Nervous system disorders Nervous system disorders-Other	2.2% 2/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Blood and lymphatic system disorders Neutrophil count decreased	3.3% 3/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Gastrointestinal disorders Non-cardiac chest pain	3.3% 3/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Cardiac disorders Palpitations	2.2% 2/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Skin and subcutaneous tissue disorders Papulopustular rash	2.2% 2/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Nervous system disorders Paresthesia	3.3% 3/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Nervous system disorders Peripheral motor neuropathy	2.2% 2/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Nervous system disorders Peripheral sensory neuropathy	5.6% 5/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Blood and lymphatic system disorders Platelet count decreased	1.1% 1/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Vascular disorders Portal vein thrombosis	1.1% 1/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Respiratory, thoracic and mediastinal disorders Postnasal drip	1.1% 1/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Respiratory, thoracic and mediastinal disorders Productive cough	1.1% 1/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Skin and subcutaneous tissue disorders Pruritus	8.9% 8/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Nervous system disorders Psychiatric disorders-Other	1.1% 1/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Cardiac disorders Pulmonary edema	1.1% 1/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Cardiac disorders Pulmonary fibrosis	1.1% 1/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Skin and subcutaneous tissue disorders Rash maculo-papular	42.2% 38/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders-Other	1.1% 1/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Respiratory, thoracic and mediastinal disorders Rhinitis infective	1.1% 1/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Cardiac disorders Sinus bradycardia	6.7% 6/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Respiratory, thoracic and mediastinal disorders Sinusitis	3.3% 3/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders-Other	6.7% 6/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Skin and subcutaneous tissue disorders Skin infection	3.3% 3/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Respiratory, thoracic and mediastinal disorders Sore throat	2.2% 2/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Gastrointestinal disorders Stomach pain	1.1% 1/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Respiratory, thoracic and mediastinal disorders Thromboembolic event	3.3% 3/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
General disorders Tinnitus	1.1% 1/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Nervous system disorders Tremor	4.4% 4/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	23.3% 21/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Renal and urinary disorders Urinary tract infection	4.4% 4/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Vascular disorders Ventricular arrhythmia	1.1% 1/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Vascular disorders Ventricular tachycardia	1.1% 1/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
General disorders Vomiting	5.6% 5/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
General disorders Weight loss	1.1% 1/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Blood and lymphatic system disorders White blood cell decreased	1.1% 1/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Gastrointestinal disorders Abdominal Pain	8.9% 8/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Nervous system disorders Agitation	1.1% 1/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Renal and urinary disorders Alanine aminotransferase increased	3.3% 3/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Renal and urinary disorders Alkaline phosphatase increased	1.1% 1/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Metabolism and nutrition disorders Hyperglycemia	1.1% 1/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Renal and urinary disorders Hyperuricemia	2.2% 2/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Nervous system disorders Hypokalemia	2.2% 2/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Infections and infestations Infections and infestations- Other	1.1% 1/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
General disorders Infusion related reaction	4.4% 4/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
General disorders Fever	22.2% 20/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
General disorders Flu like symptoms	1.1% 1/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Renal and urinary disorders Flushing	2.2% 2/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	17.8% 16/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Blood and lymphatic system disorders Anemia	7.8% 7/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Gastrointestinal disorders Anorexia	7.8% 7/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Musculoskeletal and connective tissue disorders Arthralgia	8.9% 8/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Musculoskeletal and connective tissue disorders Arthritis	1.1% 1/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Renal and urinary disorders Aspartate aminotransferase increased	2.2% 2/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Blood and lymphatic system disorders Atelectasis	1.1% 1/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Musculoskeletal and connective tissue disorders Back pain	4.4% 4/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Gastrointestinal disorders Bloating	4.4% 4/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Blood and lymphatic system disorders Blood and lymphatic system disorders-Other	1.1% 1/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Blood and lymphatic system disorders Blood bilirubin increased	1.1% 1/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Nervous system disorders Blurred Vision	10.0% 9/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Respiratory, thoracic and mediastinal disorders Bronchial Infection	2.2% 2/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Respiratory, thoracic and mediastinal disorders Chest pain-cardiac	1.1% 1/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Musculoskeletal and connective tissue disorders Chills	6.7% 6/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Nervous system disorders Concentration impairment	1.1% 1/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Gastrointestinal disorders Constipation	48.9% 44/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Respiratory, thoracic and mediastinal disorders Cough	31.1% 28/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Blood and lymphatic system disorders Creatinine Increased	2.2% 2/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Nervous system disorders Depression	2.2% 2/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Gastrointestinal disorders Diarrhea	58.9% 53/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Nervous system disorders Dizziness	14.4% 13/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
General disorders Drye Eye	8.9% 8/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
General disorders Dry mouth	3.3% 3/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Skin and subcutaneous tissue disorders Dry Skin	10.0% 9/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
General disorders General disorders and administration site condtions-Other	4.4% 4/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Nervous system disorders Dysgeusia	3.3% 3/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Respiratory, thoracic and mediastinal disorders Dyspnea	25.6% 23/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
General disorders Ear Pain	1.1% 1/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
General disorders EdemaFace	2.2% 2/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
General disorders Edema limbs	15.6% 14/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Nervous system disorders Headache	21.1% 19/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Nervous system disorders Eye disorders-Other	3.3% 3/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Nervous system disorders Fatigue	47.8% 43/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Nervous system disorders Headache and Hypotension	1.1% 1/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.
Renal and urinary disorders Hematuria	1.1% 1/90 • Adverse Events monitored/assessed for up to 24 months. All-Cause Mortality monitored/assessed up to 3 years.

Additional Information

Jason Westin, MD

The University of Texas MD Anderson Cancer Center

Phone: (713) 792-3750

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place