Trial Outcomes & Findings for Study of Enzalutamide in Patients With Castration-resistant Prostate Cancer (NCT NCT01942837)
NCT ID: NCT01942837
Last Updated: 2022-10-24
Results Overview
Serial biopsies was performed at pre-study and progression to analyze mechanisms of resistance to enzalutamide, such as alterations in AR (mutations, amplifications), tumor suppression genes, DNA repair genes, and SPOP. Whole exome sequencing was performed on tumor tissue biopsies.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
67 participants
Primary outcome timeframe
Tumor biopsies were performed at pre-study and progression. Progression occurred up to 41 months after initiation of enzalutamide.
Results posted on
2022-10-24
Participant Flow
Participant milestones
| Measure |
Enzalutamide
Participants will be treated with four 40 mg capsules (160 mg) once daily of enzalutamide taken orally with 28-days cycle. Participants will maintain a drug diary from time of initiation of study treatment to time of discontinuation from the study (Appendix C).
|
|---|---|
|
Overall Study
STARTED
|
67
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
67
|
Reasons for withdrawal
| Measure |
Enzalutamide
Participants will be treated with four 40 mg capsules (160 mg) once daily of enzalutamide taken orally with 28-days cycle. Participants will maintain a drug diary from time of initiation of study treatment to time of discontinuation from the study (Appendix C).
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Symptomatic or radiographic progression
|
49
|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Physician Decision
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Intercurrent Illness
|
1
|
|
Overall Study
On treatment
|
3
|
|
Overall Study
Never initiate the treatment
|
2
|
Baseline Characteristics
Study of Enzalutamide in Patients With Castration-resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
Enzalutamide
n=65 Participants
Participants will be treated with four 40 mg capsules (160 mg) once daily of enzalutamide taken orally. All participants without orchiectomy will be maintained on LHRH agonist/antagonist therapy. Participants will be evaluated clinically and with laboratory studies on day 1 of every 28 day cycle. Participants will maintain a drug diary from time of initiation of study treatment to time of discontinuation from the study (Appendix C).
Enzalutamide: Administration: 160 mg orally once daily. Treatment will be continued until evidence of symptomatic or radiographic progression or the participant is taken off the study for another reason.
Dosing: 160 mg orally taken once daily as four 40 mg capsules.
|
|---|---|
|
Age, Continuous
|
70 years
n=99 Participants
|
|
Sex/Gender, Customized
Male
|
65 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=99 Participants
|
|
Institution
Dana-Farber Cancer Institute
|
39 Participants
n=99 Participants
|
|
Institution
University of Washington
|
19 Participants
n=99 Participants
|
|
Institution
Beth Israel Deaconess Medical Center
|
6 Participants
n=99 Participants
|
|
Institution
South Shore Hospital
|
1 Participants
n=99 Participants
|
|
Prior chemotherapy
Yes
|
16 Participants
n=99 Participants
|
|
Prior chemotherapy
No
|
49 Participants
n=99 Participants
|
|
Prior docetaxel
Yes
|
15 Participants
n=99 Participants
|
|
Prior docetaxel
No
|
50 Participants
n=99 Participants
|
|
Prior abiraterone
Yes
|
22 Participants
n=99 Participants
|
|
Prior abiraterone
No
|
43 Participants
n=99 Participants
|
|
Prior ketoconazole
Yes
|
9 Participants
n=99 Participants
|
|
Prior ketoconazole
No
|
56 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Tumor biopsies were performed at pre-study and progression. Progression occurred up to 41 months after initiation of enzalutamide.Population: Patients who had paired biopsies of pre-study and progression.
Serial biopsies was performed at pre-study and progression to analyze mechanisms of resistance to enzalutamide, such as alterations in AR (mutations, amplifications), tumor suppression genes, DNA repair genes, and SPOP. Whole exome sequencing was performed on tumor tissue biopsies.
Outcome measures
| Measure |
Enzalutamide
n=10 Participants
Participants will be treated with four 40 mg capsules (160 mg) once daily of enzalutamide taken orally. All participants without orchiectomy will be maintained on LHRH agonist/antagonist therapy. Participants will be evaluated clinically and with laboratory studies on day 1 of every 28 day cycle. Participants will maintain a drug diary from time of initiation of study treatment to time of discontinuation from the study (Appendix C).
Enzalutamide: Administration: 160 mg orally once daily. Treatment will be continued until evidence of symptomatic or radiographic progression or the participant is taken off the study for another reason.
Dosing: 160 mg orally taken once daily as four 40 mg capsules.
|
|---|---|
|
Number of Patients With Gene Alterations
AR mutations at pre-study
|
4 Participants
|
|
Number of Patients With Gene Alterations
TP53 alteration at pre-study
|
7 Participants
|
|
Number of Patients With Gene Alterations
RB1 alteration at pre-study
|
7 Participants
|
|
Number of Patients With Gene Alterations
PTEN alteration at pre-study
|
6 Participants
|
|
Number of Patients With Gene Alterations
BRCA2 alteration at pre-study
|
4 Participants
|
|
Number of Patients With Gene Alterations
CDK12 alteration at pre-study
|
1 Participants
|
|
Number of Patients With Gene Alterations
ATM alteration at pre-study
|
1 Participants
|
|
Number of Patients With Gene Alterations
SPOP alteration at pre-study
|
4 Participants
|
|
Number of Patients With Gene Alterations
AR amplifications at pre-study
|
7 Participants
|
SECONDARY outcome
Timeframe: Not collected.Population: Serum data on the trial was collected but hormone assays were not run due to insufficient funding.
Serum testosterone were be collected at pre-study (C1D1) and every cycle and changes over time from baseline were planned to be summarized descriptively.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: PSA was measured at pre-treatment, each C1D1 (1 cycle=28 days), end of treatment, and follow-up visits (every 6 months). PSA were measured up to 52 months.Population: Patients who received ≥1 dose of enzalutamide
PSA response is defined per PCWG2 criteria (PSA decline \>=50% relative to cycle 1 PSA) and is summarized as frequency and percent.
Outcome measures
| Measure |
Enzalutamide
n=65 Participants
Participants will be treated with four 40 mg capsules (160 mg) once daily of enzalutamide taken orally. All participants without orchiectomy will be maintained on LHRH agonist/antagonist therapy. Participants will be evaluated clinically and with laboratory studies on day 1 of every 28 day cycle. Participants will maintain a drug diary from time of initiation of study treatment to time of discontinuation from the study (Appendix C).
Enzalutamide: Administration: 160 mg orally once daily. Treatment will be continued until evidence of symptomatic or radiographic progression or the participant is taken off the study for another reason.
Dosing: 160 mg orally taken once daily as four 40 mg capsules.
|
|---|---|
|
Number of Participants With a PSA Response
≥50% PSA reduction
|
38 Participants
|
|
Number of Participants With a PSA Response
≥90% PSA reduction
|
20 Participants
|
SECONDARY outcome
Timeframe: PSA was measured at pre-treatment, each C1D1 (1 cycle=28 days), end of treatment, and follow-up visits (every 6 months). PSA were measured up to 52 months.Population: Patients who experienced PSA response defined as more than equal to 50% decline from baseline.
Duration of PSA response is defined as time from the first achievement of PSA response (PSA decline \>=50% from cycle 1) to the date of PSA progression or death, whichever occurs first.
Outcome measures
| Measure |
Enzalutamide
n=38 Participants
Participants will be treated with four 40 mg capsules (160 mg) once daily of enzalutamide taken orally. All participants without orchiectomy will be maintained on LHRH agonist/antagonist therapy. Participants will be evaluated clinically and with laboratory studies on day 1 of every 28 day cycle. Participants will maintain a drug diary from time of initiation of study treatment to time of discontinuation from the study (Appendix C).
Enzalutamide: Administration: 160 mg orally once daily. Treatment will be continued until evidence of symptomatic or radiographic progression or the participant is taken off the study for another reason.
Dosing: 160 mg orally taken once daily as four 40 mg capsules.
|
|---|---|
|
Duration of PSA Response
|
3.2 months
Interval 1.4 to 7.4
|
SECONDARY outcome
Timeframe: Imaging was performed at pre-study and every 12 weeks on treatment. Treatment cycles is 28 days. Patients were assessed up to 41 months.Population: Patients with measurable disease at baseline.
Objective responses for measurable disease was evaluated using RECIST 1.1 criteria. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Response was tabulated with frequency.
Outcome measures
| Measure |
Enzalutamide
n=32 Participants
Participants will be treated with four 40 mg capsules (160 mg) once daily of enzalutamide taken orally. All participants without orchiectomy will be maintained on LHRH agonist/antagonist therapy. Participants will be evaluated clinically and with laboratory studies on day 1 of every 28 day cycle. Participants will maintain a drug diary from time of initiation of study treatment to time of discontinuation from the study (Appendix C).
Enzalutamide: Administration: 160 mg orally once daily. Treatment will be continued until evidence of symptomatic or radiographic progression or the participant is taken off the study for another reason.
Dosing: 160 mg orally taken once daily as four 40 mg capsules.
|
|---|---|
|
Response of Measurable Disease at Baseline
Complete response
|
0 Participants
|
|
Response of Measurable Disease at Baseline
Partial response
|
11 Participants
|
|
Response of Measurable Disease at Baseline
Stable disease
|
11 Participants
|
|
Response of Measurable Disease at Baseline
Progressive disease
|
7 Participants
|
|
Response of Measurable Disease at Baseline
Inevaluable/missing
|
3 Participants
|
SECONDARY outcome
Timeframe: Imaging was performed at pre-study and every 12 weeks on treatment. Treatment cycles is 28 days. Patients were assessed up to 41 months.Population: Patients with CR or PR to enzalutamide. There was no CR achieved and 11 PRs.
Duration of response of measurable disease is defined as time from the date of first objective response (PR/CR) to date of progression or death, whichever comes first. Objective response is per RECIST 1.1 criteria: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Enzalutamide
n=11 Participants
Participants will be treated with four 40 mg capsules (160 mg) once daily of enzalutamide taken orally. All participants without orchiectomy will be maintained on LHRH agonist/antagonist therapy. Participants will be evaluated clinically and with laboratory studies on day 1 of every 28 day cycle. Participants will maintain a drug diary from time of initiation of study treatment to time of discontinuation from the study (Appendix C).
Enzalutamide: Administration: 160 mg orally once daily. Treatment will be continued until evidence of symptomatic or radiographic progression or the participant is taken off the study for another reason.
Dosing: 160 mg orally taken once daily as four 40 mg capsules.
|
|---|---|
|
Duration of Response of Measurable Disease
|
2.8 months
Interval 0.03 to 7.8
|
SECONDARY outcome
Timeframe: Toxicity was reported at pre-study, every cycle, and end of treatment visit. Patients reported toxicities up to 39 months.Population: Patients who received at least one dose of enzalutamide.
For safety and tolerability, treatment-related grade 3 or higher toxicities was assessed using CTCAE v. 4.0 and was provided using frequency.
Outcome measures
| Measure |
Enzalutamide
n=65 Participants
Participants will be treated with four 40 mg capsules (160 mg) once daily of enzalutamide taken orally. All participants without orchiectomy will be maintained on LHRH agonist/antagonist therapy. Participants will be evaluated clinically and with laboratory studies on day 1 of every 28 day cycle. Participants will maintain a drug diary from time of initiation of study treatment to time of discontinuation from the study (Appendix C).
Enzalutamide: Administration: 160 mg orally once daily. Treatment will be continued until evidence of symptomatic or radiographic progression or the participant is taken off the study for another reason.
Dosing: 160 mg orally taken once daily as four 40 mg capsules.
|
|---|---|
|
Toxicity Measurements
Grade 3 colitis
|
1 Participants
|
|
Toxicity Measurements
Grade 3 fatigue
|
1 Participants
|
|
Toxicity Measurements
Grade 3 hypertension
|
4 Participants
|
SECONDARY outcome
Timeframe: Tumor biopsies will be performed at pre-treatment and end of treatment visit. Treatment cycle is 28 days. PSA was collected up to 52 months.Population: Patients who had paired biopsies of pre-study and progression.
Serial biopsies was performed at pre-study and progression to analyze mechanisms of resistance to enzalutamide, such as alterations in AR (mutations, amplifications), DNA repair genes, and SPOP. Whole exome sequencing was performed on tumor tissue biopsies. Gene alterations were tabulated with PSA response.
Outcome measures
| Measure |
Enzalutamide
n=10 Participants
Participants will be treated with four 40 mg capsules (160 mg) once daily of enzalutamide taken orally. All participants without orchiectomy will be maintained on LHRH agonist/antagonist therapy. Participants will be evaluated clinically and with laboratory studies on day 1 of every 28 day cycle. Participants will maintain a drug diary from time of initiation of study treatment to time of discontinuation from the study (Appendix C).
Enzalutamide: Administration: 160 mg orally once daily. Treatment will be continued until evidence of symptomatic or radiographic progression or the participant is taken off the study for another reason.
Dosing: 160 mg orally taken once daily as four 40 mg capsules.
|
|---|---|
|
Number of Participants With PSA Response Stratified by Gene Alterations in Serial Tumor Biopsies
PSA response among patients in Patients with AR amplification
|
3 Participants
|
|
Number of Participants With PSA Response Stratified by Gene Alterations in Serial Tumor Biopsies
PSA response among patients with AR mutation
|
1 Participants
|
|
Number of Participants With PSA Response Stratified by Gene Alterations in Serial Tumor Biopsies
PSA response among patients with SPOP alteration
|
2 Participants
|
SECONDARY outcome
Timeframe: Subsequent treatments were followed up to 31 months after discontinuation of study drug.Population: Patients who received at least one dose of enzalutamide.
Subsequent lines of therapy following study drug discontinuation was summarized descriptively.
Outcome measures
| Measure |
Enzalutamide
n=65 Participants
Participants will be treated with four 40 mg capsules (160 mg) once daily of enzalutamide taken orally. All participants without orchiectomy will be maintained on LHRH agonist/antagonist therapy. Participants will be evaluated clinically and with laboratory studies on day 1 of every 28 day cycle. Participants will maintain a drug diary from time of initiation of study treatment to time of discontinuation from the study (Appendix C).
Enzalutamide: Administration: 160 mg orally once daily. Treatment will be continued until evidence of symptomatic or radiographic progression or the participant is taken off the study for another reason.
Dosing: 160 mg orally taken once daily as four 40 mg capsules.
|
|---|---|
|
Subsequent Lines of Therapy
|
2 Lines of treatment
Interval 1.0 to 3.0
|
Adverse Events
Enzalutamide
Serious events: 8 serious events
Other events: 65 other events
Deaths: 41 deaths
Serious adverse events
| Measure |
Enzalutamide
n=65 participants at risk
Participants will be treated with four 40 mg capsules (160 mg) once daily of enzalutamide taken orally with 28-days cycle. Participants will maintain a drug diary from time of initiation of study treatment to time of discontinuation from the study (Appendix C).
|
|---|---|
|
Cardiac disorders
Cardiac arrest
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Cardiac disorders
Myocardial infarction
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Gastrointestinal disorders
Colitis
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Gastrointestinal disorders
Diarrhea
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Gastrointestinal disorders
Nausea
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
3.1%
2/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Infections and infestations
Lung infection
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Infections and infestations
Sepsis
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Infections and infestations
Urinary tract infection
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Infections and infestations
Infections and infestations - Other, specify
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Investigations
Alkaline phosphatase increased
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Investigations
Aspartate aminotransferase increased
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Investigations
Blood bilirubin increased
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Nervous system disorders
Dizziness
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Nervous system disorders
Presyncope
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Nervous system disorders
Stroke
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
Other adverse events
| Measure |
Enzalutamide
n=65 participants at risk
Participants will be treated with four 40 mg capsules (160 mg) once daily of enzalutamide taken orally with 28-days cycle. Participants will maintain a drug diary from time of initiation of study treatment to time of discontinuation from the study (Appendix C).
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
16.9%
11/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Blood and lymphatic system disorders
Hemolytic uremic syndrome
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Blood and lymphatic system disorders
Leukocytosis
|
3.1%
2/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Cardiac disorders
Atrial fibrillation
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Cardiac disorders
Atrioventricular block first degree
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Cardiac disorders
Chest pain - cardiac
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Cardiac disorders
Sinus tachycardia
|
3.1%
2/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Ear and labyrinth disorders
Hearing impaired
|
3.1%
2/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Ear and labyrinth disorders
Tinnitus
|
4.6%
3/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Ear and labyrinth disorders
Vertigo
|
6.2%
4/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Eye disorders
Blurred vision
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Eye disorders
Eye pain
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Eye disorders
Floaters
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Eye disorders
Retinal vascular disorder
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Eye disorders
Watering eyes
|
3.1%
2/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Eye disorders
Eye disorders - Other, specify
|
7.7%
5/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Gastrointestinal disorders
Abdominal pain
|
4.6%
3/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Gastrointestinal disorders
Bloating
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Gastrointestinal disorders
Constipation
|
13.8%
9/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Gastrointestinal disorders
Diarrhea
|
18.5%
12/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Gastrointestinal disorders
Dry mouth
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Gastrointestinal disorders
Dyspepsia
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Gastrointestinal disorders
Dysphagia
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Gastrointestinal disorders
Esophageal obstruction
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Gastrointestinal disorders
Gastritis
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Gastrointestinal disorders
Lip pain
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Gastrointestinal disorders
Nausea
|
15.4%
10/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Gastrointestinal disorders
Oral pain
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Gastrointestinal disorders
Stomach pain
|
3.1%
2/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
4/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
4.6%
3/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
General disorders
Chills
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
General disorders
Edema limbs
|
10.8%
7/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
General disorders
Fatigue
|
52.3%
34/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
General disorders
Fever
|
4.6%
3/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
General disorders
Gait disturbance
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
General disorders
Irritability
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
General disorders
Non-cardiac chest pain
|
6.2%
4/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
General disorders
Pain
|
35.4%
23/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
3.1%
2/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Infections and infestations
Bronchial infection
|
4.6%
3/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Infections and infestations
Eye infection
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Infections and infestations
Lung infection
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Infections and infestations
Papulopustular rash
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Infections and infestations
Paronychia
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Infections and infestations
Skin infection
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Infections and infestations
Upper respiratory infection
|
13.8%
9/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Infections and infestations
Urinary tract infection
|
4.6%
3/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Infections and infestations
Infections and infestations - Other, specify
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Injury, poisoning and procedural complications
Burn
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Injury, poisoning and procedural complications
Fall
|
9.2%
6/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Injury, poisoning and procedural complications
Fracture
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Investigations
Alanine aminotransferase increased
|
3.1%
2/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Investigations
Alkaline phosphatase increased
|
4.6%
3/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Investigations
Aspartate aminotransferase increased
|
3.1%
2/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Investigations
Blood bilirubin increased
|
3.1%
2/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Investigations
Cholesterol high
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Investigations
Creatinine increased
|
6.2%
4/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Investigations
Lymphocyte count decreased
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Investigations
Lymphocyte count increased
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Investigations
Neutrophil count decreased
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Investigations
Platelet count decreased
|
6.2%
4/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Investigations
Weight loss
|
3.1%
2/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Investigations
White blood cell decreased
|
3.1%
2/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Metabolism and nutrition disorders
Anorexia
|
13.8%
9/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Metabolism and nutrition disorders
Dehydration
|
4.6%
3/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
6.2%
4/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.8%
7/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.1%
2/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Metabolism and nutrition disorders
Hypokalemia
|
15.4%
10/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
4.6%
3/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.1%
2/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
4/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
30.8%
20/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.7%
5/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.2%
4/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.2%
4/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.1%
2/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.7%
5/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
6.2%
4/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Nervous system disorders
Concentration impairment
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Nervous system disorders
Dizziness
|
16.9%
11/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Nervous system disorders
Dysesthesia
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Nervous system disorders
Dysgeusia
|
6.2%
4/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Nervous system disorders
Encephalopathy
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Nervous system disorders
Facial muscle weakness
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Nervous system disorders
Headache
|
7.7%
5/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Nervous system disorders
Lethargy
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Nervous system disorders
Memory impairment
|
6.2%
4/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Nervous system disorders
Paresthesia
|
3.1%
2/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.6%
3/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Nervous system disorders
Syncope
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
6.2%
4/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Psychiatric disorders
Anxiety
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Psychiatric disorders
Depression
|
6.2%
4/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Psychiatric disorders
Insomnia
|
9.2%
6/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Psychiatric disorders
Libido decreased
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Psychiatric disorders
Restlessness
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Renal and urinary disorders
Acute kidney injury
|
3.1%
2/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Renal and urinary disorders
Hematuria
|
7.7%
5/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Renal and urinary disorders
Renal calculi
|
4.6%
3/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Renal and urinary disorders
Urinary frequency
|
12.3%
8/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Renal and urinary disorders
Urinary incontinence
|
4.6%
3/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Renal and urinary disorders
Urinary urgency
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
4.6%
3/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Reproductive system and breast disorders
Breast pain
|
6.2%
4/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
3.1%
2/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Reproductive system and breast disorders
Genital edema
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Reproductive system and breast disorders
Gynecomastia
|
7.7%
5/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Reproductive system and breast disorders
Pelvic pain
|
6.2%
4/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
3.1%
2/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
4.6%
3/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.8%
7/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.7%
5/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.6%
3/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal fistula
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
6.2%
4/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.2%
4/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
6.2%
4/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Vascular disorders
Flushing
|
3.1%
2/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Vascular disorders
Hematoma
|
1.5%
1/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Vascular disorders
Hot flashes
|
30.8%
20/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Vascular disorders
Hypertension
|
27.7%
18/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
|
Vascular disorders
Hypotension
|
4.6%
3/65 • Toxicities were assessed every cycle and up to 30 days after coming off from the treatment. Toxicities were collected up to ~ 44 months.
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: * Results in death * Is life-threatening. Life-threatening means that the person was at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction which hypothetically might have caused death had it occurred in a more severe form. * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place