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Trial Outcomes & Findings for Docetaxel, Carboplatin, and Rucaparib Camsylate in Treating Patients With Metastatic Castration Resistant Prostate Cancer With Homologous Recombination DNA Repair Deficiency (NCT NCT03442556)

NCT ID: NCT03442556

Last Updated: 2026-08-26

Results Overview

Radiologic progression free survival (rPFS) is defined as the time from first dose of docetaxel/carboplatin to the date of first objective evidence of radiographic progression (soft tissue or bone lesion) or death due to any cause, whichever occurs first. Radiographic disease progression includes confirmed bone disease progression and soft tissue disease progression adjudicated by investigator assessment using the RECIST 1.1/PCWG3 criteria.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

18 participants

Primary outcome timeframe

From first dose of docetaxel/carboplatin to the date of first objective evidence of radiographic progression (soft tissue or bone lesion) or death due to any cause, whichever occurs first, assessed up to 3.75 years.

Results posted on

2026-08-26

Participant Flow

Participant milestones

Participant milestones
Measure
Treatment (Docetaxel, Carboplatin, Rucaparib Camsylate)
INDUCTION: Patients receive docetaxel IV and carboplatin IV on day 1. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive rucaparib camsylate PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Induction (docetaxel and carboplatin)
STARTED
18
Induction (docetaxel and carboplatin)
COMPLETED
16
Induction (docetaxel and carboplatin)
NOT COMPLETED
2
Maintenance (rucaparib)
STARTED
16
Maintenance (rucaparib)
COMPLETED
0
Maintenance (rucaparib)
NOT COMPLETED
16

Reasons for withdrawal

Reasons for withdrawal
Measure
Treatment (Docetaxel, Carboplatin, Rucaparib Camsylate)
INDUCTION: Patients receive docetaxel IV and carboplatin IV on day 1. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive rucaparib camsylate PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Induction (docetaxel and carboplatin)
Adverse Event
1
Induction (docetaxel and carboplatin)
Death
1
Maintenance (rucaparib)
Adverse Event
2
Maintenance (rucaparib)
Death
1
Maintenance (rucaparib)
Disease Progression
12
Maintenance (rucaparib)
Withdrawal by Subject
1

Baseline Characteristics

Docetaxel, Carboplatin, and Rucaparib Camsylate in Treating Patients With Metastatic Castration Resistant Prostate Cancer With Homologous Recombination DNA Repair Deficiency

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Treatment (Docetaxel, Carboplatin, Rucaparib Camsylate)
n=18 Participants
INDUCTION: Patients receive docetaxel IV and carboplatin IV on day 1. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive rucaparib camsylate PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Age, Categorical
<=18 years
0 Participants
n=31 Participants
Age, Categorical
Between 18 and 65 years
6 Participants
n=31 Participants
Age, Categorical
>=65 years
12 Participants
n=31 Participants
Sex: Female, Male
Female
0 Participants
n=31 Participants
Sex: Female, Male
Male
18 Participants
n=31 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=31 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
16 Participants
n=31 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants
n=31 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=31 Participants
Race (NIH/OMB)
Asian
2 Participants
n=31 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=31 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=31 Participants
Race (NIH/OMB)
White
15 Participants
n=31 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=31 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=31 Participants
PSA at Diagnosis
Participant 1
16 ng/mL
n=31 Participants
PSA at Diagnosis
Participant 2
5 ng/mL
n=31 Participants
PSA at Diagnosis
Participant 3
42 ng/mL
n=31 Participants
PSA at Diagnosis
Participant 4
129 ng/mL
n=31 Participants
PSA at Diagnosis
Participant 5
156 ng/mL
n=31 Participants
PSA at Diagnosis
Participant 6
540 ng/mL
n=31 Participants
PSA at Diagnosis
Participant 7
6 ng/mL
n=31 Participants
PSA at Diagnosis
Participant 8
588 ng/mL
n=31 Participants
PSA at Diagnosis
Participant 9
132 ng/mL
n=31 Participants
PSA at Diagnosis
Participant 10
7 ng/mL
n=31 Participants
PSA at Diagnosis
Participant 11
25 ng/mL
n=31 Participants
PSA at Diagnosis
Participant 12
36 ng/mL
n=31 Participants
PSA at Diagnosis
Participant 13
17 ng/mL
n=31 Participants
PSA at Diagnosis
Participant 14
13 ng/mL
n=31 Participants
PSA at Diagnosis
Participant 15
2040 ng/mL
n=31 Participants
PSA at Diagnosis
Participant 16
35 ng/mL
n=31 Participants
PSA at Diagnosis
Participant 17
4374 ng/mL
n=31 Participants
PSA at Diagnosis
Participant 18
1101 ng/mL
n=31 Participants
Primary treatment (radical prostatectomy or radiation)
Prostatectomy
5 Participants
n=31 Participants
Primary treatment (radical prostatectomy or radiation)
Radiation
1 Participants
n=31 Participants
Primary treatment (radical prostatectomy or radiation)
Neither
12 Participants
n=31 Participants
Prior therapies for castration resistant prostate cancer
1 Therapy
4 Participants
n=31 Participants
Prior therapies for castration resistant prostate cancer
2 Therapies
8 Participants
n=31 Participants
Prior therapies for castration resistant prostate cancer
3 or more Therapies
6 Participants
n=31 Participants
BRCA/ATM/other HR gene mutation status
ATM
7 participants
n=31 Participants
BRCA/ATM/other HR gene mutation status
BRCA1
3 participants
n=31 Participants
BRCA/ATM/other HR gene mutation status
BRCA2
8 participants
n=31 Participants
BRCA/ATM/other HR gene mutation status
PALB2
1 participants
n=31 Participants
BRCA/ATM/other HR gene mutation status
FANCA
1 participants
n=31 Participants
BRCA/ATM/other HR gene mutation status
CHD1 + SPOP
1 participants
n=31 Participants
Clinical Stage at Diagnosis
De novo metastatic disease
12 Participants
n=31 Participants
Clinical Stage at Diagnosis
Localized disease at diagnosis
6 Participants
n=31 Participants
TNM Stage at Diagnosis
pT3aN0
1 Participants
n=31 Participants
TNM Stage at Diagnosis
pT3bpN1
1 Participants
n=31 Participants
TNM Stage at Diagnosis
T3bN0
1 Participants
n=31 Participants
TNM Stage at Diagnosis
pT3aR0N1
1 Participants
n=31 Participants
TNM Stage at Diagnosis
T2aN1M0
1 Participants
n=31 Participants
TNM Stage at Diagnosis
Unknown
13 Participants
n=31 Participants

PRIMARY outcome

Timeframe: From first dose of docetaxel/carboplatin to the date of first objective evidence of radiographic progression (soft tissue or bone lesion) or death due to any cause, whichever occurs first, assessed up to 3.75 years.

Population: Overall study cohort

Radiologic progression free survival (rPFS) is defined as the time from first dose of docetaxel/carboplatin to the date of first objective evidence of radiographic progression (soft tissue or bone lesion) or death due to any cause, whichever occurs first. Radiographic disease progression includes confirmed bone disease progression and soft tissue disease progression adjudicated by investigator assessment using the RECIST 1.1/PCWG3 criteria.

Outcome measures

Outcome measures
Measure
Treatment (Docetaxel, Carboplatin, Rucaparib Camsylate)
n=18 Participants
INDUCTION: Patients receive docetaxel IV and carboplatin IV on day 1. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive rucaparib camsylate PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Radiographic Progression Free Survival Assessed by Assessment Using the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1/Prostate Cancer Working Group 3 (PCWG3) Criteria
8.1 Months
Interval 6.5 to 31.2

SECONDARY outcome

Timeframe: Up to 3.75 years

Population: A total of 14 patients had measurable disease.

Overall response rate of measurable disease (PCWG3): radiologic ORR (CR or PR per modified RECIST Version 1.1 criteria and no bone progression per PCWG3 prior to a CR or PR) by investigator assessment in patients with measurable visceral and/or nodal disease at baseline per IRR (Cohort A). An analysis of radiologic ORR by the investigator will also be conducted as supportive to the primary endpoint.

Outcome measures

Outcome measures
Measure
Treatment (Docetaxel, Carboplatin, Rucaparib Camsylate)
n=14 Participants
INDUCTION: Patients receive docetaxel IV and carboplatin IV on day 1. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive rucaparib camsylate PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Response Rate (ORR) of Measurable Disease (PCWG3) (Complete Response or Partial Response) Assessed by Modified RECIST Version 1.1 Criteria
Partial Response
3 Participants
Overall Response Rate (ORR) of Measurable Disease (PCWG3) (Complete Response or Partial Response) Assessed by Modified RECIST Version 1.1 Criteria
Stable Disease
9 Participants
Overall Response Rate (ORR) of Measurable Disease (PCWG3) (Complete Response or Partial Response) Assessed by Modified RECIST Version 1.1 Criteria
Progressive Disease
2 Participants

SECONDARY outcome

Timeframe: Up to 13 weeks

Population: Overall cohort of 18 patients that participated in the induction phase.

Rate of confirmed PSA decrease from baseline, assessed by a local laboratory (PSA50 and PSA90). Number of patients achieving a PSA decline from baseline of ≥50% (PSA50) or ≥90% (PSA90). The change in PSA was calculated relative to the PSA level at the start of cycle 1.

Outcome measures

Outcome measures
Measure
Treatment (Docetaxel, Carboplatin, Rucaparib Camsylate)
n=18 Participants
INDUCTION: Patients receive docetaxel IV and carboplatin IV on day 1. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive rucaparib camsylate PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Prostate-specific Antigen (PSA) Nadir After Induction
PSA decline from baseline of ≥50%
7 Participants
Prostate-specific Antigen (PSA) Nadir After Induction
PSA decline from baseline of ≥90%
1 Participants
Prostate-specific Antigen (PSA) Nadir After Induction
PSA decline from baseline of <50%
4 Participants
Prostate-specific Antigen (PSA) Nadir After Induction
PSA Increase
6 Participants

SECONDARY outcome

Timeframe: Up to 3.5 years

Population: Two patients were not eligible to receive subsequent PARPi therapy after chemotherapy because of abnormal laboratory results. The population is the remaining 16 participants who received PARPi (rucaparib).

Rate of confirmed PSA decrease from baseline, assessed by a local laboratory (PSA50 and PSA90) using postchemotherapy PSA as the baseline. The most recent PSA level before PARPi initiation was used as the baseline PSA. Number of patients achieving a PSA decline from baseline of ≥50% (PSA50) or ≥90% (PSA90).

Outcome measures

Outcome measures
Measure
Treatment (Docetaxel, Carboplatin, Rucaparib Camsylate)
n=16 Participants
INDUCTION: Patients receive docetaxel IV and carboplatin IV on day 1. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive rucaparib camsylate PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
PSA Nadir After Maintenance
PSA decline from postchemotherapy of <50%
1 Participants
PSA Nadir After Maintenance
PSA Increase
7 Participants
PSA Nadir After Maintenance
PSA decline from postchemotherapy of ≥50%
4 Participants
PSA Nadir After Maintenance
PSA decline from postchemotherapy of ≥90%
4 Participants

SECONDARY outcome

Timeframe: From the date that a response (PSA decrease >= 50%) is first reported to the time that PSA progression is first documented, assessed up to 3.75 years

Population: 10 of the 18 Subjects has a PSA50 response and then later had PSA progression.

PSA-response duration: duration of confirmed response is defined as the time from the date that a response (PSA decrease ≥ 50%) is first reported to the time that PSA progression is first documented.

Outcome measures

Outcome measures
Measure
Treatment (Docetaxel, Carboplatin, Rucaparib Camsylate)
n=10 Participants
INDUCTION: Patients receive docetaxel IV and carboplatin IV on day 1. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive rucaparib camsylate PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
PSA Response Duration
Subject 1
12.43 Months
PSA Response Duration
Subject 2
0.67 Months
PSA Response Duration
Subject 3
36.86 Months
PSA Response Duration
Subject 4
24.03 Months
PSA Response Duration
Subject 5
12 Months
PSA Response Duration
Subject 6
4.86 Months
PSA Response Duration
Subject 7
4.6 Months
PSA Response Duration
Subject 8
19.86 Months
PSA Response Duration
Subject 9
4.56 Months
PSA Response Duration
Subject 10
8.23 Months

SECONDARY outcome

Timeframe: From first dose of docetaxel/carboplatin to the date that a >= 25% increase and absolute increase of >= 2 ng/mL above the nadir (or baseline value for patients who did not have a decline in PSA) in PSA was measured, assessed up to 3.75 years.

Population: Overall study cohort

Time to PSA progression is defined as the time from first dose of docetaxel/carboplatin to the date that a ≥ 25% increase and absolute increase of ≥ 2 ng/mL above the nadir (or baseline value for patients who did not have a decline in PSA) in PSA was measured. The increase must be confirmed by a second consecutive assessment conducted at least 3 weeks later.

Outcome measures

Outcome measures
Measure
Treatment (Docetaxel, Carboplatin, Rucaparib Camsylate)
n=18 Participants
INDUCTION: Patients receive docetaxel IV and carboplatin IV on day 1. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive rucaparib camsylate PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Time to PSA Progression (PCWG3)
5.2 Months
Interval 3.2 to 20.9

Adverse Events

Induction Phase (Docetaxel and Carboplatin)

Serious events: 2 serious events
Other events: 18 other events
Deaths: 1 deaths

Maintenance Phase (Rucaparib Camsylate)

Serious events: 1 serious events
Other events: 16 other events
Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure
Induction Phase (Docetaxel and Carboplatin)
n=18 participants at risk
INDUCTION: Patients receive docetaxel IV and carboplatin IV on day 1. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Docetaxel: Given IV
Maintenance Phase (Rucaparib Camsylate)
n=16 participants at risk
MAINTENANCE: Patients receive rucaparib camsylate PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Rucaparib Camsylate: Given PO
Metabolism and nutrition disorders
Starvation Ketoacidosis
5.6%
1/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
0.00%
0/16 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Metabolism and nutrition disorders
Acute Ketoacidosis
5.6%
1/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
0.00%
0/16 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Gastrointestinal disorders
Intractable Vomiting
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Nervous system disorders
Cerebral Venous Sinus Thrombosis
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Skin and subcutaneous tissue disorders
Skin ulceration, right foot
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.

Other adverse events

Other adverse events
Measure
Induction Phase (Docetaxel and Carboplatin)
n=18 participants at risk
INDUCTION: Patients receive docetaxel IV and carboplatin IV on day 1. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Docetaxel: Given IV
Maintenance Phase (Rucaparib Camsylate)
n=16 participants at risk
MAINTENANCE: Patients receive rucaparib camsylate PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Rucaparib Camsylate: Given PO
Blood and lymphatic system disorders
Leukocytosis
5.6%
1/18 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
0.00%
0/16 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Skin and subcutaneous tissue disorders
Hair Loss
16.7%
3/18 • Number of events 3 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
0.00%
0/16 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Cardiac disorders
Tachycardia
11.1%
2/18 • Number of events 2 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Respiratory, thoracic and mediastinal disorders
Dyspnea on exertion
11.1%
2/18 • Number of events 2 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
18.8%
3/16 • Number of events 3 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
General disorders
Fatigue
83.3%
15/18 • Number of events 17 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
75.0%
12/16 • Number of events 29 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Metabolism and nutrition disorders
Hypophosphatemia
5.6%
1/18 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
18.8%
3/16 • Number of events 3 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Gastrointestinal disorders
Constipation
44.4%
8/18 • Number of events 8 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
37.5%
6/16 • Number of events 9 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
General disorders
Fever
16.7%
3/18 • Number of events 3 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
0.00%
0/16 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Gastrointestinal disorders
Diarrhea
44.4%
8/18 • Number of events 8 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
18.8%
3/16 • Number of events 3 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Gastrointestinal disorders
Gastroesophageal reflux disease
11.1%
2/18 • Number of events 3 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Gastrointestinal disorders
Nausea
50.0%
9/18 • Number of events 9 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
37.5%
6/16 • Number of events 9 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Metabolism and nutrition disorders
Anorexia
38.9%
7/18 • Number of events 7 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
31.2%
5/16 • Number of events 5 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Investigations
Weight loss
11.1%
2/18 • Number of events 3 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
31.2%
5/16 • Number of events 5 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Metabolism and nutrition disorders
Hypomagnesemia
27.8%
5/18 • Number of events 5 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
18.8%
3/16 • Number of events 3 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Musculoskeletal and connective tissue disorders
Mid-thoracic Back Pain
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Investigations
Elevated Liver Transaminases
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Skin and subcutaneous tissue disorders
Spontaneous Blistering Lesions on Skin
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Skin and subcutaneous tissue disorders
Rash
22.2%
4/18 • Number of events 4 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
12.5%
2/16 • Number of events 2 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Ear and labyrinth disorders
Ototoxicity
5.6%
1/18 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
0.00%
0/16 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Ear and labyrinth disorders
Tinnitus
16.7%
3/18 • Number of events 3 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Investigations
Thrombocytopenia
27.8%
5/18 • Number of events 7 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
25.0%
4/16 • Number of events 4 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Blood and lymphatic system disorders
Anemia
61.1%
11/18 • Number of events 12 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
37.5%
6/16 • Number of events 19 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Investigations
Alkaline phosphatase increased
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Musculoskeletal and connective tissue disorders
Back Pain (with radicular symptoms)
5.6%
1/18 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
0.00%
0/16 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Infections and infestations
Cellulitis
5.6%
1/18 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
0.00%
0/16 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Musculoskeletal and connective tissue disorders
Left Hip Pain
5.6%
1/18 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Investigations
Neutropenia
5.6%
1/18 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 3 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Endocrine disorders
Electrolyte Imbalances
5.6%
1/18 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
0.00%
0/16 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Investigations
Elevated creatinine
5.6%
1/18 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
31.2%
5/16 • Number of events 5 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Infections and infestations
Upper Respiratory Infection
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
25.0%
4/16 • Number of events 4 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Infections and infestations
Common Cold
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Nervous system disorders
Headache
5.6%
1/18 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
12.5%
2/16 • Number of events 3 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Renal and urinary disorders
Lower Urinary Tract Symptoms
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Respiratory, thoracic and mediastinal disorders
Dyspnea
5.6%
1/18 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
12.5%
2/16 • Number of events 3 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Gastrointestinal disorders
Abdominal Pain
11.1%
2/18 • Number of events 2 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
18.8%
3/16 • Number of events 4 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Respiratory, thoracic and mediastinal disorders
Cough
5.6%
1/18 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
12.5%
2/16 • Number of events 3 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Metabolism and nutrition disorders
Hypokalemia
5.6%
1/18 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 2 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Renal and urinary disorders
Dysuria
5.6%
1/18 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
0.00%
0/16 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Musculoskeletal and connective tissue disorders
Left Lower Back Pain
5.6%
1/18 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Vascular disorders
Facial flushing and warmth
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Vascular disorders
Heat intolerance and diaphoresis
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Blood and lymphatic system disorders
Leukopenia
5.6%
1/18 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 2 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Musculoskeletal and connective tissue disorders
Arthralgia, right shoulder
5.6%
1/18 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
0.00%
0/16 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Nervous system disorders
Peripheral Neuropathy
11.1%
2/18 • Number of events 2 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
18.8%
3/16 • Number of events 5 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Nervous system disorders
Dysgeusia
22.2%
4/18 • Number of events 4 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Eye disorders
Worsening Vision
5.6%
1/18 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
0.00%
0/16 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Gastrointestinal disorders
Vomiting
16.7%
3/18 • Number of events 3 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
18.8%
3/16 • Number of events 4 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Musculoskeletal and connective tissue disorders
Upper leg knee pain
5.6%
1/18 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
0.00%
0/16 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Nervous system disorders
Dizziness
16.7%
3/18 • Number of events 5 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
General disorders
Pain
5.6%
1/18 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
0.00%
0/16 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Nervous system disorders
Tingling in left wrist and arm, positional
5.6%
1/18 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
0.00%
0/16 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Musculoskeletal and connective tissue disorders
Right Lower Back Pain
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Musculoskeletal and connective tissue disorders
Shoulder Pain
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Musculoskeletal and connective tissue disorders
Ankle Pain
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
12.5%
2/16 • Number of events 3 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Musculoskeletal and connective tissue disorders
Lower Back Pain
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Infections and infestations
Urinary Tract Infection
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 2 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Musculoskeletal and connective tissue disorders
Right Hip Pain
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Psychiatric disorders
Insomnia
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Infections and infestations
Covid-19 Infection
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
18.8%
3/16 • Number of events 3 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Nervous system disorders
Chemo Brain
5.6%
1/18 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
0.00%
0/16 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Renal and urinary disorders
Nocturia
5.6%
1/18 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Eye disorders
Watering eyes
5.6%
1/18 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
0.00%
0/16 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Injury, poisoning and procedural complications
Slowed healing of prior fibular fracture
5.6%
1/18 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
0.00%
0/16 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Metabolism and nutrition disorders
Hyperglycemia
11.1%
2/18 • Number of events 2 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 3 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Respiratory, thoracic and mediastinal disorders
Epistaxis
11.1%
2/18 • Number of events 2 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
0.00%
0/16 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Nervous system disorders
Vasovagal syncope
5.6%
1/18 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
0.00%
0/16 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Injury, poisoning and procedural complications
Right knee injury
5.6%
1/18 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
0.00%
0/16 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
General disorders
Cancer Related Pain
16.7%
3/18 • Number of events 4 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Vascular disorders
Hot Flashes
5.6%
1/18 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
12.5%
2/16 • Number of events 2 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Gastrointestinal disorders
Gum sensitivity
5.6%
1/18 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
0.00%
0/16 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Gastrointestinal disorders
Rectal pain
5.6%
1/18 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
0.00%
0/16 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Infections and infestations
Folliculitis
5.6%
1/18 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
0.00%
0/16 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Nervous system disorders
Paresthesia
5.6%
1/18 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
0.00%
0/16 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Gastrointestinal disorders
Mucositis
5.6%
1/18 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
0.00%
0/16 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Vascular disorders
Pulmonary Embolism
5.6%
1/18 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Musculoskeletal and connective tissue disorders
Myalgias
5.6%
1/18 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
0.00%
0/16 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Respiratory, thoracic and mediastinal disorders
Nasal congestion
5.6%
1/18 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
0.00%
0/16 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
General disorders
Cold intolerance
5.6%
1/18 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
0.00%
0/16 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
5.6%
1/18 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
0.00%
0/16 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Gastrointestinal disorders
Mouth sores
11.1%
2/18 • Number of events 2 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
0.00%
0/16 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Investigations
Elevated LFTs
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
12.5%
2/16 • Number of events 3 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Psychiatric disorders
Depression
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
12.5%
2/16 • Number of events 2 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Psychiatric disorders
Anxiety
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 2 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Gastrointestinal disorders
Fecal incontinence
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Respiratory, thoracic and mediastinal disorders
Postnasal Drip
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 3 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Musculoskeletal and connective tissue disorders
Chest tightness
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Gastrointestinal disorders
Dysphagia
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 3 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Renal and urinary disorders
Bladder spams
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Cardiac disorders
Palpitations
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Musculoskeletal and connective tissue disorders
Left Shoulder Pain
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Vascular disorders
Hypertension
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 2 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Infections and infestations
Sepsis
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Metabolism and nutrition disorders
Hypernatremia
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Renal and urinary disorders
Urinary Retention
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Skin and subcutaneous tissue disorders
Desquamation
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Renal and urinary disorders
Urinary incontinence
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Gastrointestinal disorders
Flatulence
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
12.5%
2/16 • Number of events 2 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Skin and subcutaneous tissue disorders
Nail discoloration
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Investigations
Elevated bilirubin
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 3 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Musculoskeletal and connective tissue disorders
Right knee pain
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Nervous system disorders
Tremor
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Metabolism and nutrition disorders
Hypocalcemia
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 2 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Musculoskeletal and connective tissue disorders
Anterior Thigh Aching
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Skin and subcutaneous tissue disorders
Skin Ulceration
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Injury, poisoning and procedural complications
Fall
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
12.5%
2/16 • Number of events 2 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
General disorders
Gait Disturbance
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
General disorders
Non-Cardiac Left Chest Pain
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Metabolism and nutrition disorders
Dehydration
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 2 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Nervous system disorders
Memory Impairment
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Ear and labyrinth disorders
Vertigo
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Psychiatric disorders
Confusion
5.6%
1/18 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Investigations
Aspartate aminotransferase increase
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Skin and subcutaneous tissue disorders
Pruritus
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Investigations
Alanine aminotransferase increased
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Musculoskeletal and connective tissue disorders
Jaw pain
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Nervous system disorders
Facial nerve disorder
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Skin and subcutaneous tissue disorders
Left foot erythema
5.6%
1/18 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
0.00%
0/16 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Skin and subcutaneous tissue disorders
Burning sensation in palms
5.6%
1/18 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
0.00%
0/16 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Skin and subcutaneous tissue disorders
Dry Skin
5.6%
1/18 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
0.00%
0/16 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Gastrointestinal disorders
Hypogastric abdominal pain (burning sensation)
5.6%
1/18 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
0.00%
0/16 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Vascular disorders
Hypotension
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
12.5%
2/16 • Number of events 2 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Endocrine disorders
Hypothyroidism
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Ear and labyrinth disorders
Bilateral Impacted Eardrums
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Renal and urinary disorders
Acute kidney injury
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Blood and lymphatic system disorders
Cytopenias
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
Infections and infestations
Sinus Infection
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
6.2%
1/16 • Number of events 1 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
General disorders
Lower extremity edema
0.00%
0/18 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.
12.5%
2/16 • Number of events 2 • Only treatment-emergent adverse events (TEAEs) were collected: TEAEs are defined as AEs with onset date on or after the date of first dose of study drug until the date of the last study drug dose plus 28 days (up to 3.75 years total).
The existence of an AE may be concluded from a spontaneous report of the patient; from the physical examination; or from special tests such as the ECG, laboratory assessments, or other study-specified procedure (source of AE). Symptoms reported spontaneously by the patient during the physical examination would also qualify as an AE. The severity of the toxicities will be graded according to the NCI CTCAE Version 4.03 or later.

Additional Information

Dr. Heather Cheng

University of Washington

Phone: 206-667-7991

Results disclosure agreements

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