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Trial Outcomes & Findings for Avoiding Growth Factor During Paclitaxel Treatment in Breast Cancer (NCT NCT02698891)

NCT ID: NCT02698891

Last Updated: 2022-05-06

Results Overview

Rate of participants who completed Paclitaxel treatment in 7 weeks while omitting Neulasta™ (Pegfilgrastim). Neulasta is administered based on the following pre-specified safety criteria. * The patient experiences a prior episode of fever and neutropenia. * If the patient has an active infection this decision will be at provider discretion.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

127 participants

Primary outcome timeframe

7 Weeks

Results posted on

2022-05-06

Participant Flow

Enrollment Period: May 2016 and November 2018

Participant milestones

Participant milestones
Measure
Paclitaxel
After the screening procedures confirm participation in the research study: 175 mg/m\^2 Paclitaxel via IV, once every 2 weeks x 4 cycles. (1 cycle = 2 weeks) \-- Neulasta™ (Pegfilgrastim) 6 mg SQ x1 is administered on day 2 of each treatment cycle, approximately 24 hours after the chemotherapy treatment, if: * The patient experiences a prior episode of fever and neutropenia. * If the patient has an active infection this decision will be at provider discretion. * If Neulasta™(Pegfilgrastim) is administered in any Paclitaxel cycle for a given patient, it will be then administered for all future cycles. Paclitaxel Neulasta
Overall Study
STARTED
127
Overall Study
Treated
125
Overall Study
COMPLETED
115
Overall Study
NOT COMPLETED
12

Reasons for withdrawal

Reasons for withdrawal
Measure
Paclitaxel
After the screening procedures confirm participation in the research study: 175 mg/m\^2 Paclitaxel via IV, once every 2 weeks x 4 cycles. (1 cycle = 2 weeks) \-- Neulasta™ (Pegfilgrastim) 6 mg SQ x1 is administered on day 2 of each treatment cycle, approximately 24 hours after the chemotherapy treatment, if: * The patient experiences a prior episode of fever and neutropenia. * If the patient has an active infection this decision will be at provider discretion. * If Neulasta™(Pegfilgrastim) is administered in any Paclitaxel cycle for a given patient, it will be then administered for all future cycles. Paclitaxel Neulasta
Overall Study
Withdrawal by Subject
2
Overall Study
deemed ineligible
1
Overall Study
Adverse Event
9

Baseline Characteristics

Avoiding Growth Factor During Paclitaxel Treatment in Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Paclitaxel
n=125 Participants
After the screening procedures confirm participation in the research study: 175 mg/m\^2 Paclitaxel via IV, once every 2 weeks x 4 cycles. (1 cycle = 2 weeks) \-- Neulasta™ (Pegfilgrastim) 6 mg SQ x1 is administered on day 2 of each treatment cycle, approximately 24 hours after the chemotherapy treatment, if: * The patient experiences a prior episode of fever and neutropenia. * If the patient has an active infection this decision will be at provider discretion. * If Neulasta™(Pegfilgrastim) is administered in any Paclitaxel cycle for a given patient, it will be then administered for all future cycles. Paclitaxel Neulasta
Age, Continuous
46 years
n=99 Participants
Sex: Female, Male
Female
125 Participants
n=99 Participants
Sex: Female, Male
Male
0 Participants
n=99 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
7 Participants
n=99 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
113 Participants
n=99 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
5 Participants
n=99 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 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
9 Participants
n=99 Participants
Race (NIH/OMB)
White
101 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
Body Surface Area
1.81 m^2
n=99 Participants
ECOG Performance Status
0 - Fully Active
119 Participants
n=99 Participants
ECOG Performance Status
1 - Restricted
6 Participants
n=99 Participants
Menopausal Status
Premenopausal
84 Participants
n=99 Participants
Menopausal Status
Postmenopausal
41 Participants
n=99 Participants
Stage at Initial Diagnosis
Stage I
16 Participants
n=99 Participants
Stage at Initial Diagnosis
Stage II
81 Participants
n=99 Participants
Stage at Initial Diagnosis
Stage III
27 Participants
n=99 Participants
Stage at Initial Diagnosis
Unknown
1 Participants
n=99 Participants
Histology
Ductal Carcinoma
94 Participants
n=99 Participants
Histology
Lobular Carcinoma
16 Participants
n=99 Participants
Histology
Mixed Lobular and Ductal Carcinoma
13 Participants
n=99 Participants
Histology
Other
2 Participants
n=99 Participants
Hormone Receptor Status
Estrogen and Progesterone Receptor Positive
80 Participants
n=99 Participants
Hormone Receptor Status
Estrogen and Progesterone Receptor Negative
44 Participants
n=99 Participants
Hormone Receptor Status
Unknown
1 Participants
n=99 Participants
Chemotherapy Setting
Neoadjuvant
57 Participants
n=99 Participants
Chemotherapy Setting
Adjuvant
68 Participants
n=99 Participants

PRIMARY outcome

Timeframe: 7 Weeks

Rate of participants who completed Paclitaxel treatment in 7 weeks while omitting Neulasta™ (Pegfilgrastim). Neulasta is administered based on the following pre-specified safety criteria. * The patient experiences a prior episode of fever and neutropenia. * If the patient has an active infection this decision will be at provider discretion.

Outcome measures

Outcome measures
Measure
Paclitaxel
n=125 Participants
After the screening procedures confirm participation in the research study: 175 mg/m\^2 Paclitaxel via IV, once every 2 weeks x 4 cycles. (1 cycle = 2 weeks) \-- Neulasta™ (Pegfilgrastim) 6 mg SQ x1 is administered on day 2 of each treatment cycle, approximately 24 hours after the chemotherapy treatment, if: * The patient experiences a prior episode of fever and neutropenia. * If the patient has an active infection this decision will be at provider discretion. * If Neulasta™(Pegfilgrastim) is administered in any Paclitaxel cycle for a given patient, it will be then administered for all future cycles. Paclitaxel Neulasta
Rate of Paclitaxel Treatment Completion Within 7 Weeks
90 percentage of participants
Interval 83.0 to 94.0

SECONDARY outcome

Timeframe: While on study, up to 6.2 months

Percentage of participants experiencing grade 3-5 neutropenia per Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. while on treatment.

Outcome measures

Outcome measures
Measure
Paclitaxel
n=125 Participants
After the screening procedures confirm participation in the research study: 175 mg/m\^2 Paclitaxel via IV, once every 2 weeks x 4 cycles. (1 cycle = 2 weeks) \-- Neulasta™ (Pegfilgrastim) 6 mg SQ x1 is administered on day 2 of each treatment cycle, approximately 24 hours after the chemotherapy treatment, if: * The patient experiences a prior episode of fever and neutropenia. * If the patient has an active infection this decision will be at provider discretion. * If Neulasta™(Pegfilgrastim) is administered in any Paclitaxel cycle for a given patient, it will be then administered for all future cycles. Paclitaxel Neulasta
Rate of Grade 3-5 Neutropenia
8.8 percentage of participants
Interval 5.0 to 15.7

SECONDARY outcome

Timeframe: While on study, up to 6.2 months

Percentage of participants experiencing a grade 3 or 4 toxicity excluding grade 3 or 4 neutropenia or febrile neutropenia per Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Outcome measures

Outcome measures
Measure
Paclitaxel
n=125 Participants
After the screening procedures confirm participation in the research study: 175 mg/m\^2 Paclitaxel via IV, once every 2 weeks x 4 cycles. (1 cycle = 2 weeks) \-- Neulasta™ (Pegfilgrastim) 6 mg SQ x1 is administered on day 2 of each treatment cycle, approximately 24 hours after the chemotherapy treatment, if: * The patient experiences a prior episode of fever and neutropenia. * If the patient has an active infection this decision will be at provider discretion. * If Neulasta™(Pegfilgrastim) is administered in any Paclitaxel cycle for a given patient, it will be then administered for all future cycles. Paclitaxel Neulasta
Rate of Grade 3-4 Toxicities, Excluding Neutropenia
12 percentage of participants
Interval 7.4 to 18.9

SECONDARY outcome

Timeframe: While on treatment, up to 2.3 months

Percentage of participants experiencing dose reductions due to adverse events.

Outcome measures

Outcome measures
Measure
Paclitaxel
n=125 Participants
After the screening procedures confirm participation in the research study: 175 mg/m\^2 Paclitaxel via IV, once every 2 weeks x 4 cycles. (1 cycle = 2 weeks) \-- Neulasta™ (Pegfilgrastim) 6 mg SQ x1 is administered on day 2 of each treatment cycle, approximately 24 hours after the chemotherapy treatment, if: * The patient experiences a prior episode of fever and neutropenia. * If the patient has an active infection this decision will be at provider discretion. * If Neulasta™(Pegfilgrastim) is administered in any Paclitaxel cycle for a given patient, it will be then administered for all future cycles. Paclitaxel Neulasta
Rate of Chemotherapy Dose Reductions
13.6 percentage of participants
Interval 8.7 to 20.7

SECONDARY outcome

Timeframe: While on treatment, up to 2.3 months

Percentage of Participants who received all planned chemotherapy cycles.

Outcome measures

Outcome measures
Measure
Paclitaxel
n=125 Participants
After the screening procedures confirm participation in the research study: 175 mg/m\^2 Paclitaxel via IV, once every 2 weeks x 4 cycles. (1 cycle = 2 weeks) \-- Neulasta™ (Pegfilgrastim) 6 mg SQ x1 is administered on day 2 of each treatment cycle, approximately 24 hours after the chemotherapy treatment, if: * The patient experiences a prior episode of fever and neutropenia. * If the patient has an active infection this decision will be at provider discretion. * If Neulasta™(Pegfilgrastim) is administered in any Paclitaxel cycle for a given patient, it will be then administered for all future cycles. Paclitaxel Neulasta
Percentage of Participants Who Received All Planned Chemotherapy Cycles
92 percentage of participants
Interval 85.8 to 96.1

SECONDARY outcome

Timeframe: While on treatment, up to 2.3 months

The percentage of participants who experienced a hypersensitivity reaction on cycles 3 and 4 without use of dexamethasone (a steroid)..

Outcome measures

Outcome measures
Measure
Paclitaxel
n=125 Participants
After the screening procedures confirm participation in the research study: 175 mg/m\^2 Paclitaxel via IV, once every 2 weeks x 4 cycles. (1 cycle = 2 weeks) \-- Neulasta™ (Pegfilgrastim) 6 mg SQ x1 is administered on day 2 of each treatment cycle, approximately 24 hours after the chemotherapy treatment, if: * The patient experiences a prior episode of fever and neutropenia. * If the patient has an active infection this decision will be at provider discretion. * If Neulasta™(Pegfilgrastim) is administered in any Paclitaxel cycle for a given patient, it will be then administered for all future cycles. Paclitaxel Neulasta
Rate of Hypersensitivity Reactions on Cycles 3-4 of Paclitaxel, When Steroid is Avoided
2.4 percentage of participants
Interval 0.5 to 6.9

SECONDARY outcome

Timeframe: While on treatment, up to 2.3 months

Number of participants with dose delays due to various different adverse events. Adverse events classified using CTCAEv 4.0.

Outcome measures

Outcome measures
Measure
Paclitaxel
n=125 Participants
After the screening procedures confirm participation in the research study: 175 mg/m\^2 Paclitaxel via IV, once every 2 weeks x 4 cycles. (1 cycle = 2 weeks) \-- Neulasta™ (Pegfilgrastim) 6 mg SQ x1 is administered on day 2 of each treatment cycle, approximately 24 hours after the chemotherapy treatment, if: * The patient experiences a prior episode of fever and neutropenia. * If the patient has an active infection this decision will be at provider discretion. * If Neulasta™(Pegfilgrastim) is administered in any Paclitaxel cycle for a given patient, it will be then administered for all future cycles. Paclitaxel Neulasta
Number of Participants With Dose Delays by Reason for Delay
Cardiotoxicity
1 Participants
Number of Participants With Dose Delays by Reason for Delay
Febrile Neutropenia
1 Participants
Number of Participants With Dose Delays by Reason for Delay
Neutropenia without Fever
12 Participants
Number of Participants With Dose Delays by Reason for Delay
Nonhematologic Toxicity
3 Participants
Number of Participants With Dose Delays by Reason for Delay
Infection
1 Participants
Number of Participants With Dose Delays by Reason for Delay
Neurotoxicity
3 Participants
Number of Participants With Dose Delays by Reason for Delay
Other
3 Participants

SECONDARY outcome

Timeframe: While on treatment, up to 2.3 months

An algorithm was used to estimated median and range of potential savings per 100 patients if the use of pegfilgrastim was omitted from treatment. The algorithm is designed assuming an average wholesale price in the United States ranging from $1,361 to $4,655 for myeloid growth factors such as filgrastim (8 days of growth factor support/cycle) and peg-filgrastim ($5,443 to $18,622 for 4 cycles on the basis of April 2019 Medicare Part B Drug Average Sales Price), and applying a 95.7% reduction in the use of pegfilgrastim during paclitaxel.

Outcome measures

Outcome measures
Measure
Paclitaxel
n=125 Participants
After the screening procedures confirm participation in the research study: 175 mg/m\^2 Paclitaxel via IV, once every 2 weeks x 4 cycles. (1 cycle = 2 weeks) \-- Neulasta™ (Pegfilgrastim) 6 mg SQ x1 is administered on day 2 of each treatment cycle, approximately 24 hours after the chemotherapy treatment, if: * The patient experiences a prior episode of fever and neutropenia. * If the patient has an active infection this decision will be at provider discretion. * If Neulasta™(Pegfilgrastim) is administered in any Paclitaxel cycle for a given patient, it will be then administered for all future cycles. Paclitaxel Neulasta
Median of Savings When Omitting Pegfilgrastim From Treatment.
1.1 millions of dollars per 100 patients
Interval 0.5 to 1.7

Adverse Events

Paclitaxel

Serious events: 4 serious events
Other events: 63 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Paclitaxel
n=127 participants at risk
After the screening procedures confirm participation in the research study: 175 mg/m\^2 Paclitaxel via IV, once every 2 weeks x 4 cycles. (1 cycle = 2 weeks) \-- Neulasta™ (Pegfilgrastim) 6 mg SQ x1 is administered on day 2 of each treatment cycle, approximately 24 hours after the chemotherapy treatment, if: * The patient experiences a prior episode of fever and neutropenia. * If the patient has an active infection this decision will be at provider discretion. * If Neulasta™(Pegfilgrastim) is administered in any Paclitaxel cycle for a given patient, it will be then administered for all future cycles. Paclitaxel Neulasta
Blood and lymphatic system disorders
Febrile neutropenia
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Nervous system disorders
Peripheral motor neuropathy
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Investigations
Neutrophil count decreased
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.

Other adverse events

Other adverse events
Measure
Paclitaxel
n=127 participants at risk
After the screening procedures confirm participation in the research study: 175 mg/m\^2 Paclitaxel via IV, once every 2 weeks x 4 cycles. (1 cycle = 2 weeks) \-- Neulasta™ (Pegfilgrastim) 6 mg SQ x1 is administered on day 2 of each treatment cycle, approximately 24 hours after the chemotherapy treatment, if: * The patient experiences a prior episode of fever and neutropenia. * If the patient has an active infection this decision will be at provider discretion. * If Neulasta™(Pegfilgrastim) is administered in any Paclitaxel cycle for a given patient, it will be then administered for all future cycles. Paclitaxel Neulasta
Gastrointestinal disorders
Bloating
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Skin and subcutaneous tissue disorders
sore spots on nails, ridging
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Gastrointestinal disorders
Colitis
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders ? rash to cheeks
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Skin and subcutaneous tissue disorders
Ridging and sore spots
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Blood and lymphatic system disorders
Anemia
20.5%
26/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Blood and lymphatic system disorders
Febrile neutropenia
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Gastrointestinal disorders
Constipation
10.2%
13/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Cardiac disorders
Chest pain - cardiac
2.4%
3/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Cardiac disorders
Left ventricular systolic dysfunction
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Cardiac disorders
Palpitations
1.6%
2/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Cardiac disorders
Restrictive cardiomyopathy
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Cardiac disorders
Sinus tachycardia
2.4%
3/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Cardiac disorders
Supraventricular tachycardia
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Eye disorders
Blurred vision
1.6%
2/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Eye disorders
Dry eye
3.1%
4/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Eye disorders
Watering eyes
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Gastrointestinal disorders
Abdominal pain
1.6%
2/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Gastrointestinal disorders
Anal pain
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Gastrointestinal disorders
Diarrhea
5.5%
7/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Gastrointestinal disorders
Dry mouth
2.4%
3/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Gastrointestinal disorders
Dyspepsia
3.9%
5/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Gastrointestinal disorders
Gastroesophageal reflux disease
2.4%
3/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Gastrointestinal disorders
Hemorrhoids
2.4%
3/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Gastrointestinal disorders
Mucositis oral
7.9%
10/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Gastrointestinal disorders
Nausea
16.5%
21/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Gastrointestinal disorders
Oral pain
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Gastrointestinal disorders
Stomach pain
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Gastrointestinal disorders
Toothache
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Gastrointestinal disorders
Vomiting
3.1%
4/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
General disorders
Chills
2.4%
3/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
General disorders
Edema face
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
General disorders
Edema limbs
1.6%
2/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
General disorders
Fatigue
28.3%
36/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
General disorders
Fever
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
General disorders
Flu like symptoms
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
General disorders
Infusion related reaction
1.6%
2/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
General disorders
Localized edema
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
General disorders
Pain
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Infections and infestations
Lung infection
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Infections and infestations
Nail infection
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Infections and infestations
Paronychia
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Infections and infestations
Pharyngitis
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Infections and infestations
Sinusitis
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Infections and infestations
Infections and infestations - Other, specify
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Investigations
Alanine aminotransferase increased
4.7%
6/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Investigations
Alkaline phosphatase increased
2.4%
3/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Investigations
Aspartate aminotransferase increased
7.1%
9/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Investigations
CD4 lymphocytes decreased
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Investigations
Creatinine increased
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Investigations
Electrocardiogram QT corrected interval prolonged
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Investigations
Lymphocyte count decreased
2.4%
3/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Investigations
Neutrophil count decreased
15.0%
19/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Investigations
Platelet count decreased
2.4%
3/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Investigations
Weight loss
2.4%
3/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Investigations
White blood cell decreased
3.1%
4/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Metabolism and nutrition disorders
Anorexia
1.6%
2/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Metabolism and nutrition disorders
Dehydration
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Metabolism and nutrition disorders
Hyperglycemia
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Metabolism and nutrition disorders
Hypoalbuminemia
2.4%
3/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Metabolism and nutrition disorders
Hypocalcemia
2.4%
3/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Metabolism and nutrition disorders
Hypokalemia
3.1%
4/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Metabolism and nutrition disorders
Hypomagnesemia
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Metabolism and nutrition disorders
Hyponatremia
3.1%
4/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Metabolism and nutrition disorders
Obesity
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Musculoskeletal and connective tissue disorders
Arthralgia
14.2%
18/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Musculoskeletal and connective tissue disorders
Bone pain
4.7%
6/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
1.6%
2/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Musculoskeletal and connective tissue disorders
Myalgia
8.7%
11/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Musculoskeletal and connective tissue disorders
Pain in extremity
2.4%
3/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Nervous system disorders
Concentration impairment
2.4%
3/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Nervous system disorders
Dysgeusia
3.9%
5/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Nervous system disorders
Headache
5.5%
7/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Nervous system disorders
Lethargy
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Nervous system disorders
Memory impairment
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Nervous system disorders
Paresthesia
3.9%
5/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Nervous system disorders
Peripheral motor neuropathy
4.7%
6/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Nervous system disorders
Peripheral sensory neuropathy
21.3%
27/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Nervous system disorders
Nervous system disorders - Other, specify
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Psychiatric disorders
Anxiety
3.1%
4/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Psychiatric disorders
Depression
1.6%
2/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Psychiatric disorders
Insomnia
4.7%
6/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Renal and urinary disorders
Urinary incontinence
1.6%
2/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Renal and urinary disorders
Urinary retention
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Reproductive system and breast disorders
Breast pain
1.6%
2/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
1.6%
2/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Respiratory, thoracic and mediastinal disorders
Cough
6.3%
8/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Respiratory, thoracic and mediastinal disorders
Dyspnea
7.1%
9/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Respiratory, thoracic and mediastinal disorders
Nasal congestion
2.4%
3/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Respiratory, thoracic and mediastinal disorders
Postnasal drip
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Respiratory, thoracic and mediastinal disorders
Sneezing
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Respiratory, thoracic and mediastinal disorders
Sore throat
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Respiratory, thoracic and mediastinal disorders
Wheezing
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
1.6%
2/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Skin and subcutaneous tissue disorders
Alopecia
15.0%
19/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Skin and subcutaneous tissue disorders
Bullous dermatitis
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Skin and subcutaneous tissue disorders
Dry skin
5.5%
7/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Skin and subcutaneous tissue disorders
Nail discoloration
5.5%
7/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Skin and subcutaneous tissue disorders
Nail loss
1.6%
2/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Skin and subcutaneous tissue disorders
Nail ridging
1.6%
2/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
3.1%
4/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Skin and subcutaneous tissue disorders
Pruritus
2.4%
3/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Skin and subcutaneous tissue disorders
Rash acneiform
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Skin and subcutaneous tissue disorders
Rash maculo-papular
5.5%
7/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Skin and subcutaneous tissue disorders
Skin ulceration
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Vascular disorders
Hot flashes
5.5%
7/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Vascular disorders
Hypertension
12.6%
16/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
Vascular disorders
Thromboembolic event
0.79%
1/127 • While on study, up to 6.2 months
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.

Additional Information

Dr. Nancy Lin

Dana-Farber Cancer Institute

Phone: 617-632-3800

Results disclosure agreements

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