Trial Outcomes & Findings for LY3022855 With BRAF/MEK Inhibition in Patients With Melanoma (NCT NCT03101254)
NCT ID: NCT03101254
Last Updated: 2024-07-17
Results Overview
DLT is based on CTCAE v4.03. DLT refers to toxicities experienced during the first cycle of treatment that are possibly, probably, or definitely related to the study medication regimen, and grade or category outlined in protocol section 5.4.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
5 participants
Primary outcome timeframe
Participants were assessed cycle 1 on day 1, 8, 15 and 22. The observation period for DLT evaluation was the first cycle (28 days).
Results posted on
2024-07-17
Participant Flow
Participant enrolled from June 2017 to March 2019.
Participant milestones
| Measure |
Phase I: Dose Level 1: LY3022855 (50mg) + Vemurafenib + Cobimetinib
* LY3022855 50mg IV administered intravenously every week
* Vemurafenib 960 mg BID administered by mouth twice daily
* Cobimetinib 60 mg administered by mouth once daily on days 1-21of each cycle
|
Phase I: Dose Level 2: LY3022855 (75mg) + Vemurafenib + Cobimetinib
* LY3022855 75mg IV administered intravenously every week
* Vemurafenib 960 mg BID administered by mouth twice daily
* Cobimetinib 60 mg administered by mouth once daily on days 1-21of each cycle
|
Phase I: Dose Level 3: LY3022855 (100mg) + Vemurafenib + Cobimetinib
* LY3022855 100mg IV administered intravenously every week
* Vemurafenib 960 mg BID administered by mouth twice daily
* Cobimetinib 60 mg administered by mouth once daily on days 1-21of each cycle
|
Phase II: LY3022855 (MTD) + Vemurafenib + Cobimetinib
* MTD of LY3022855 was not established
* Vemurafenib planned 960 mg BID administered by mouth twice daily
* Cobimetinib planned 60 mg administered by mouth once daily on days 1-21of each cycle
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
5
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Phase I: Dose Level 1: LY3022855 (50mg) + Vemurafenib + Cobimetinib
n=5 Participants
* Starting dose level of LY3022855 50mg IV administered intravenously every week
* Vemurafenib 960 mg BID administered by mouth twice daily
* Cobimetinib 60 mg administered by mouth once daily on days 1-21of each cycle
|
|---|---|
|
Age, Continuous
|
52.4 years
STANDARD_DEVIATION 15.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Participants were assessed cycle 1 on day 1, 8, 15 and 22. The observation period for DLT evaluation was the first cycle (28 days).DLT is based on CTCAE v4.03. DLT refers to toxicities experienced during the first cycle of treatment that are possibly, probably, or definitely related to the study medication regimen, and grade or category outlined in protocol section 5.4.
Outcome measures
| Measure |
Phase I: Dose Level 1: LY3022855 (50mg) + Vemurafenib + Cobimetinib
n=5 Participants
* LY3022855 50mg IV administered intravenously every week
* Vemurafenib 960 mg BID administered by mouth twice daily
* Cobimetinib 60 mg administered by mouth once daily on days 1-21of each cycle
|
|---|---|
|
Dose Limiting Toxicity (DLT) [Phase I]
|
1 Participants
|
PRIMARY outcome
Timeframe: Participants were assessed cycle 1 on day 1, 8, 15 and 22. The observation period is the first cycle (28 days).See previous primary outcome measure for the DLT defination. A conventional algorithm (3+3 design) will be used to identify the MTD, escalating on 0/3 or 1/6 DLTs, and de-escalating if two DLTs are encountered. The MTD will be the highest dose level at which ≤ 1/6 subjects experience a DLT. If dose level 1 is discovered to be intolerable (with 2/3 or ≥ 2/6 subjects experiencing a DLT), the trial will be discontinued.
Outcome measures
| Measure |
Phase I: Dose Level 1: LY3022855 (50mg) + Vemurafenib + Cobimetinib
n=5 Participants
* LY3022855 50mg IV administered intravenously every week
* Vemurafenib 960 mg BID administered by mouth twice daily
* Cobimetinib 60 mg administered by mouth once daily on days 1-21of each cycle
|
|---|---|
|
LY3022855 Maximum Tolerated Dose (MTD) With Vemurafenib and Cobimetinib Combination [Phase I]
|
50 mg
|
SECONDARY outcome
Timeframe: Disease was assessed radiologically at baseline and after treatment every 3-4 months. Median follow-up for survival was 202 days with maximum of 480 days.Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) or death. Per RECIST 1.1 criteria.
Outcome measures
| Measure |
Phase I: Dose Level 1: LY3022855 (50mg) + Vemurafenib + Cobimetinib
n=5 Participants
* LY3022855 50mg IV administered intravenously every week
* Vemurafenib 960 mg BID administered by mouth twice daily
* Cobimetinib 60 mg administered by mouth once daily on days 1-21of each cycle
|
|---|---|
|
Median Progression-Free Survival (PFS) [Phase I]
|
3.7 months
Interval 1.9 to 37.2
|
SECONDARY outcome
Timeframe: Radiologic measurements is performed at Cycle 2 Day 28 and at the day 28 of every 2 cycles of treatment thereafter. Median treatment duration is 112 days (range 56 - 1008 days ).The overall response rate (ORR) was defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on RECISTv1.1 criteria.
Outcome measures
| Measure |
Phase I: Dose Level 1: LY3022855 (50mg) + Vemurafenib + Cobimetinib
n=5 Participants
* LY3022855 50mg IV administered intravenously every week
* Vemurafenib 960 mg BID administered by mouth twice daily
* Cobimetinib 60 mg administered by mouth once daily on days 1-21of each cycle
|
|---|---|
|
Overall Response Rate (ORR) [Phase I]
|
20.0 percentage of participants
Interval 1.0 to 66.0
|
SECONDARY outcome
Timeframe: AE evaluated on treatment on each cycle at day 1, 8, 15 and 22. Median treatment duration for this study cohort was 112 days (range 56 - 1008 days).Population: Phase II never started
All grade 3-5 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv4.03 that are not resolved in accordance with treatment guidelines were counted. Rate is the proportion of treated participants experiencing at least one of these adverse events as defined during the time of observation.
Outcome measures
Outcome data not reported
Adverse Events
Phase I: Dose Level 1: LY3022855 (50mg) + Vemurafenib + Cobimetinib
Serious events: 2 serious events
Other events: 5 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Phase I: Dose Level 1: LY3022855 (50mg) + Vemurafenib + Cobimetinib
n=5 participants at risk
* LY3022855 50mg IV administered intravenously every week
* Vemurafenib 960 mg BID administered by mouth twice daily
* Cobimetinib 60 mg administered by mouth once daily on days 1-21of each cycle
|
|---|---|
|
Skin and subcutaneous tissue disorders
Maculopapular rash
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Hepatobiliary disorders
Cholecystitis
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Infections and infestations
Gallbladder infection
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
Other adverse events
| Measure |
Phase I: Dose Level 1: LY3022855 (50mg) + Vemurafenib + Cobimetinib
n=5 participants at risk
* LY3022855 50mg IV administered intravenously every week
* Vemurafenib 960 mg BID administered by mouth twice daily
* Cobimetinib 60 mg administered by mouth once daily on days 1-21of each cycle
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
40.0%
2/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Cardiac disorders
Sinus tachycardia
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Endocrine disorders
Hypothyroidism
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Eye disorders
Blurred vision
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Eye disorders
Dry eye
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Eye disorders
Eye pain
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Eye disorders
Watering eyes
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Eye disorders
Eye disorders - Other, specify
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Gastrointestinal disorders
Abdominal pain
|
40.0%
2/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
5/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Gastrointestinal disorders
Dry mouth
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Gastrointestinal disorders
Duodenal hemorrhage
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Gastrointestinal disorders
Flatulence
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Gastrointestinal disorders
Mucositis oral
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Gastrointestinal disorders
Nausea
|
80.0%
4/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
General disorders
Chills
|
40.0%
2/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
General disorders
Edema face
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
General disorders
Edema limbs
|
40.0%
2/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
General disorders
Fatigue
|
60.0%
3/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
General disorders
Fever
|
40.0%
2/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
General disorders
Flu like symptoms
|
40.0%
2/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Infections and infestations
Skin infection
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Investigations
Alanine aminotransferase increased
|
40.0%
2/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Investigations
Alkaline phosphatase increased
|
60.0%
3/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Investigations
Aspartate aminotransferase increased
|
60.0%
3/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Investigations
Cholesterol high
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Investigations
CPK increased
|
40.0%
2/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Investigations
Creatinine increased
|
60.0%
3/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Investigations
Neutrophil count decreased
|
40.0%
2/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Investigations
Weight loss
|
40.0%
2/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Investigations
White blood cell decreased
|
40.0%
2/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Metabolism and nutrition disorders
Anorexia
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Metabolism and nutrition disorders
Dehydration
|
80.0%
4/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
40.0%
2/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
60.0%
3/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
40.0%
2/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
60.0%
3/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Nervous system disorders
Dizziness
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Nervous system disorders
Dysgeusia
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Nervous system disorders
Sinus pain
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Psychiatric disorders
Anxiety
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Renal and urinary disorders
Hematuria
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Renal and urinary disorders
Renal calculi
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
40.0%
2/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
100.0%
5/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
40.0%
2/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
80.0%
4/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
40.0%
2/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Vascular disorders
Hot flashes
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
|
Vascular disorders
Hypertension
|
20.0%
1/5 • Measured while on-treatment of 1 cycle = 28 days. Mortality observation period is median of 202 days and maximum of 480 days.
A serious adverse event (SAE) is any adverse event during this study that results in one of the following outcomes: death; hospitalization for greater than 24 hours; prolonging an existing inpatient hospitalization; a life-threatening experience (that is, immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; considered significant by the investigator for any other reason. All others are classified as other adverse event (OAE).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place