Trial Outcomes & Findings for Ibrutinib in Treating Patients With Relapsed or Refractory Follicular Lymphoma (NCT NCT01849263)

Last Updated: 2025-09-10

Results Overview

Overall response rate defined as a partial response (PR) or complete response (CR) as the objective status at any time during treatment, evaluated using the Cheson et al. Revised Response Criteria for Malignant Lymphoma. Ninety-five percent binomial confidence intervals for the true success proportion will be calculated. A CR is defined as the disappearance of all evidence of disease. A PR is defined as ≥ 50% decrease in the sum of the products of dimensions (SPD) of up to 6 largest dominant masses; no increase in size of other nodes and regression on CT, and no increase in size of liver/spleen.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

41 participants

Primary outcome timeframe

Up to 5 years

Results posted on

2025-09-10

Participant Flow

Forty-one patients were enrolled to this study. One patient cancelled prior to beginning protocol treatment and was excluded from all analyses.

Participant milestones

Participant milestones
Measure	Treatment (Ibrutinib) Patients receive 560 mg ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease at the end of course 2 may continue on therapy until the end of course 5 at the discretion of the treating physician.
Overall Study STARTED	40
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ibrutinib in Treating Patients With Relapsed or Refractory Follicular Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Ibrutinib) n=40 Participants Patients receive 560 mg ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease at the end of course 2 may continue on therapy until the end of course 5 at the discretion of the treating physician.
Age, Continuous	64 years n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants
Region of Enrollment Canada	5 participants n=5 Participants
Region of Enrollment Singapore	2 participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 5 years

Population: All patients that began protocol treatment were included in this analysis.

Outcome measures

Outcome measures
Measure	Treatment (Ibrutinib) n=40 Participants Patients receive 560 mg ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease at the end of course 2 may continue on therapy until the end of course 5 at the discretion of the treating physician.
Overall Response Rate	0.375 proportion of participants Interval 0.227 to 0.542

SECONDARY outcome

Timeframe: Time from the date at which the patient's objective status is first noted to be a CR or PR to the earliest date progression is documented, assessed up to 5 years

Population: All patients that reported a response during treatment are included in this analysis.

Duration of response is defined as the time from first evidence of a response to the first documented time of progressive disease (PD). Response and Progression were assessed using the Cheson et al. Revised Response Criteria for Malignant Lymphoma. \> \> A CR is defined as the disappearance of all evidence of disease. A PR is defined as ≥ 50% decrease in the sum of the products of dimensions (SPD) of up to 6 largest dominant masses; no increase in size of other nodes and regression on CT, and no increase in size of liver/spleen.Estimated using the method of Kaplan-Meier.\> \> Progressive Disease (PD) is defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir.

Outcome measures

Outcome measures
Measure	Treatment (Ibrutinib) n=15 Participants Patients receive 560 mg ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease at the end of course 2 may continue on therapy until the end of course 5 at the discretion of the treating physician.
Duration of Response	13.9 months Interval 5.8 to Too few events occurred to estimate the upper bound of the confidence interval.

SECONDARY outcome

Timeframe: Assessed up to 5 years

Population: All patients beginning protocol treatment are included in this endpoint.

Overall Survival is defined as the time from registration to death due to any cause. Estimated using the method of Kaplan-Meier.

Outcome measures

Outcome measures
Measure	Treatment (Ibrutinib) n=40 Participants Patients receive 560 mg ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease at the end of course 2 may continue on therapy until the end of course 5 at the discretion of the treating physician.
Overall Survival	NA months Too few events have occurred to estimate a median and confidence interval.

SECONDARY outcome

Timeframe: Time from registration to progression or death due to any cause, assessed up to 5 years

Population: All patients beginning protocol treatment are included in this endpoint.

Progression-Free Survival is defined as the time from registration to documented progression or death due to any cause, whichever occurs first. Estimated using the method of Kaplan-Meier.

Outcome measures

Outcome measures
Measure	Treatment (Ibrutinib) n=40 Participants Patients receive 560 mg ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease at the end of course 2 may continue on therapy until the end of course 5 at the discretion of the treating physician.
Progression-free Survival	14.0 months Interval 7.4 to 16.3

SECONDARY outcome

Timeframe: Time from the date of registration to the date at which the patient's objective status is first noted to be a CR or PR, assessed up to 5 years

Population: All patients reporting a response during treatment are included in this analysis.

Time to response is defined for all evaluable patients who have achieved a confirmed response as the time from the date of registration to the date at which the patient's objective status is first noted to be a CR or PR.The median and 95% confidence interval will be calculated using the methods of Kaplan-Meier.

Outcome measures

Outcome measures
Measure	Treatment (Ibrutinib) n=15 Participants Patients receive 560 mg ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease at the end of course 2 may continue on therapy until the end of course 5 at the discretion of the treating physician.
Time to Response	4.6 months Interval 1.8 to 10.4

SECONDARY outcome

Timeframe: Time from registration to the date of initiation of subsequent treatment for lymphoma, assessed up to 5 years

Population: All patients beginning protocol treatment were included in this endpoint analysis.

Time to subsequent treatment is defined as the time from registration to the date of initiation of subsequent treatment for lymphoma. The distribution of time to subsequent treatment will be estimated using the method of Kaplan-Meier.

Outcome measures

Outcome measures
Measure	Treatment (Ibrutinib) n=40 Participants Patients receive 560 mg ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease at the end of course 2 may continue on therapy until the end of course 5 at the discretion of the treating physician.
Time to Subsequent Treatment	17.7 months Interval 13.4 to 28.4

SECONDARY outcome

Timeframe: Time from registration to the date of treatment discontinuation due to any reason, assessed up to 5 years

Population: All patients beginning protocol treatment were included in this endpoint analysis.

Time to treatment failure is defined as the time from registration to the date of treatment discontinuation due to any reason. The distribution of time to treatment failure will be estimated using the method of Kaplan-Meier.

Outcome measures

Outcome measures
Measure	Treatment (Ibrutinib) n=40 Participants Patients receive 560 mg ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease at the end of course 2 may continue on therapy until the end of course 5 at the discretion of the treating physician.
Time to Treatment Failure	10.0 months Interval 6.0 to 16.2

Adverse Events

Treatment (Ibrutinib)

Serious events: 10 serious events

Other events: 40 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Ibrutinib) n=40 participants at risk Patients receive 560 mg ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease at the end of course 2 may continue on therapy until the end of course 5 at the discretion of the treating physician.
Blood and lymphatic system disorders Spleen disorder	2.5% 1/40 • Number of events 1 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Cardiac disorders Cardiac disorders - Other, specify	2.5% 1/40 • Number of events 1 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Cardiac disorders Chest pain - cardiac	2.5% 1/40 • Number of events 1 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Cardiac disorders Supraventricular tachycardia	2.5% 1/40 • Number of events 1 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Gastrointestinal disorders Diarrhea	5.0% 2/40 • Number of events 3 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Gastrointestinal disorders Gastric hemorrhage	2.5% 1/40 • Number of events 1 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
General disorders Fatigue	2.5% 1/40 • Number of events 1 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Infections and infestations Infections and infestations - Other, specify	5.0% 2/40 • Number of events 2 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Infections and infestations Lung infection	2.5% 1/40 • Number of events 1 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Injury, poisoning and procedural complications Hip fracture	2.5% 1/40 • Number of events 1 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Metabolism and nutrition disorders Hypercalcemia	2.5% 1/40 • Number of events 1 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	2.5% 1/40 • Number of events 1 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Vascular disorders Hematoma	2.5% 1/40 • Number of events 1 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.

Other adverse events

Other adverse events
Measure	Treatment (Ibrutinib) n=40 participants at risk Patients receive 560 mg ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease at the end of course 2 may continue on therapy until the end of course 5 at the discretion of the treating physician.
Blood and lymphatic system disorders Anemia	40.0% 16/40 • Number of events 62 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Blood and lymphatic system disorders Leukocytosis	7.5% 3/40 • Number of events 3 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Cardiac disorders Cardiac disorders - Other, specify	2.5% 1/40 • Number of events 1 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Ear and labyrinth disorders Ear and labyrinth disorders - Other, specify	2.5% 1/40 • Number of events 1 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Ear and labyrinth disorders Tinnitus	2.5% 1/40 • Number of events 1 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Eye disorders Blurred vision	2.5% 1/40 • Number of events 1 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Eye disorders Cataract	2.5% 1/40 • Number of events 1 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Eye disorders Conjunctivitis	2.5% 1/40 • Number of events 1 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Gastrointestinal disorders Abdominal distension	2.5% 1/40 • Number of events 1 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Gastrointestinal disorders Abdominal pain	5.0% 2/40 • Number of events 3 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Gastrointestinal disorders Bloating	2.5% 1/40 • Number of events 1 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Gastrointestinal disorders Constipation	15.0% 6/40 • Number of events 8 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Gastrointestinal disorders Diarrhea	52.5% 21/40 • Number of events 130 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Gastrointestinal disorders Dry mouth	2.5% 1/40 • Number of events 1 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Gastrointestinal disorders Dyspepsia	2.5% 1/40 • Number of events 3 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Gastrointestinal disorders Flatulence	2.5% 1/40 • Number of events 1 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Gastrointestinal disorders Gastroesophageal reflux disease	5.0% 2/40 • Number of events 2 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	5.0% 2/40 • Number of events 4 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Gastrointestinal disorders Hemorrhoidal hemorrhage	2.5% 1/40 • Number of events 1 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Gastrointestinal disorders Mucositis oral	10.0% 4/40 • Number of events 15 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Gastrointestinal disorders Nausea	32.5% 13/40 • Number of events 35 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Gastrointestinal disorders Oral pain	2.5% 1/40 • Number of events 1 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Gastrointestinal disorders Vomiting	20.0% 8/40 • Number of events 8 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
General disorders Edema limbs	15.0% 6/40 • Number of events 15 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
General disorders Fatigue	67.5% 27/40 • Number of events 145 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
General disorders Fever	5.0% 2/40 • Number of events 2 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
General disorders Flu like symptoms	5.0% 2/40 • Number of events 4 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
General disorders Pain	2.5% 1/40 • Number of events 1 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Infections and infestations Bladder infection	2.5% 1/40 • Number of events 2 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Infections and infestations Conjunctivitis infective	2.5% 1/40 • Number of events 1 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Infections and infestations Gum infection	2.5% 1/40 • Number of events 2 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Infections and infestations Infections and infestations - Other, specify	7.5% 3/40 • Number of events 3 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Infections and infestations Lung infection	7.5% 3/40 • Number of events 4 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Infections and infestations Otitis media	2.5% 1/40 • Number of events 1 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Infections and infestations Sinusitis	10.0% 4/40 • Number of events 5 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Infections and infestations Skin infection	5.0% 2/40 • Number of events 2 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Infections and infestations Upper respiratory infection	17.5% 7/40 • Number of events 10 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Infections and infestations Urinary tract infection	5.0% 2/40 • Number of events 2 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Infections and infestations Vaginal infection	5.0% 2/40 • Number of events 2 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Injury, poisoning and procedural complications Bruising	15.0% 6/40 • Number of events 12 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Investigations Alanine aminotransferase increased	5.0% 2/40 • Number of events 3 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Investigations Alkaline phosphatase increased	2.5% 1/40 • Number of events 1 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Investigations Aspartate aminotransferase increased	5.0% 2/40 • Number of events 4 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Investigations Blood bilirubin increased	10.0% 4/40 • Number of events 6 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Investigations CD4 lymphocytes decreased	2.5% 1/40 • Number of events 1 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Investigations Lymphocyte count decreased	27.5% 11/40 • Number of events 52 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Investigations Neutrophil count decreased	12.5% 5/40 • Number of events 16 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Investigations Platelet count decreased	57.5% 23/40 • Number of events 137 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Investigations Weight loss	2.5% 1/40 • Number of events 7 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Investigations White blood cell decreased	12.5% 5/40 • Number of events 8 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Metabolism and nutrition disorders Anorexia	7.5% 3/40 • Number of events 4 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Metabolism and nutrition disorders Hyperglycemia	2.5% 1/40 • Number of events 2 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Metabolism and nutrition disorders Hyperkalemia	2.5% 1/40 • Number of events 1 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Metabolism and nutrition disorders Hypernatremia	2.5% 1/40 • Number of events 2 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Metabolism and nutrition disorders Hyperuricemia	5.0% 2/40 • Number of events 3 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Metabolism and nutrition disorders Hypoalbuminemia	2.5% 1/40 • Number of events 1 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Metabolism and nutrition disorders Hypocalcemia	2.5% 1/40 • Number of events 1 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Metabolism and nutrition disorders Hypokalemia	2.5% 1/40 • Number of events 1 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Musculoskeletal and connective tissue disorders Arthralgia	5.0% 2/40 • Number of events 2 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Musculoskeletal and connective tissue disorders Back pain	7.5% 3/40 • Number of events 3 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	2.5% 1/40 • Number of events 2 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Musculoskeletal and connective tissue disorders Myalgia	7.5% 3/40 • Number of events 5 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	5.0% 2/40 • Number of events 32 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	2.5% 1/40 • Number of events 1 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Nervous system disorders Dizziness	5.0% 2/40 • Number of events 2 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Nervous system disorders Dysgeusia	7.5% 3/40 • Number of events 4 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Nervous system disorders Headache	5.0% 2/40 • Number of events 4 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Nervous system disorders Peripheral sensory neuropathy	2.5% 1/40 • Number of events 1 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Psychiatric disorders Insomnia	2.5% 1/40 • Number of events 1 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Renal and urinary disorders Urinary tract obstruction	2.5% 1/40 • Number of events 1 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	2.5% 1/40 • Number of events 1 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Respiratory, thoracic and mediastinal disorders Cough	5.0% 2/40 • Number of events 5 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	5.0% 2/40 • Number of events 5 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	7.5% 3/40 • Number of events 3 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Respiratory, thoracic and mediastinal disorders Postnasal drip	2.5% 1/40 • Number of events 1 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Respiratory, thoracic and mediastinal disorders Sore throat	2.5% 1/40 • Number of events 1 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Skin and subcutaneous tissue disorders Alopecia	2.5% 1/40 • Number of events 3 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Skin and subcutaneous tissue disorders Dry skin	7.5% 3/40 • Number of events 8 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Skin and subcutaneous tissue disorders Pruritus	2.5% 1/40 • Number of events 2 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Skin and subcutaneous tissue disorders Rash acneiform	2.5% 1/40 • Number of events 1 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	17.5% 7/40 • Number of events 16 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	12.5% 5/40 • Number of events 9 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Skin and subcutaneous tissue disorders Skin ulceration	2.5% 1/40 • Number of events 1 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Vascular disorders Hematoma	2.5% 1/40 • Number of events 4 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Vascular disorders Hypertension	2.5% 1/40 • Number of events 2 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.
Vascular disorders Thromboembolic event	2.5% 1/40 • Number of events 1 • Adverse events were collected at the end of each cycle of treatment, up to cycle 35. Adverse events were recorded at the end of each cycle of treatment.

Additional Information

Nancy L. Bartlett, M.D.

Washington University School of Medicine

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60