Trial Outcomes & Findings for Anti-PD-1 Monoclonal Antibody in Advanced, Trastuzumab-resistant, HER2-positive Breast Cancer (NCT NCT02129556)
NCT ID: NCT02129556
Last Updated: 2019-02-15
Results Overview
Determination of dose-limiting toxicity (DLT) which is defined as an adverse event or abnormal laboratory value assessed as suspected to be trial treatment related (possible, probable or definite) and unrelated to disease or disease progression. Toxicities and lab values will be graded according to the NCI CTCAE (v4.0). 1. Any grade-3 or greater non-hematological adverse event lasting at least one week; 2. Any grade-4 hematological toxicity; or, 3. Any adverse event resulting in a delay starting cycle 2 of more than 14 days.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
58 participants
Primary outcome timeframe
Within the first 21 days
Results posted on
2019-02-15
Participant Flow
Participant milestones
| Measure |
Phase Ib 2 mg/kg
HER2-positive, PD-L1 expressing, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy. In the Phase Ib portion of the trial, two weight-based doses of MK-3475 were specified in the dose escalation (2 mg/kg and 10 mg/kg).
|
Phase Ib 10 mg/kg
HER2-positive, PD-L1 expressing, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy. In the Phase Ib portion of the trial, two weight-based doses of MK-3475 were specified in the dose escalation (2 mg/kg and 10 mg/kg).
|
Phase II PD-L1+
HER2-positive, PD-L1 expressing, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy. The Phase II portion of the trial used a flat dose of 200 mg of MK-3475 based on emerging data from the sponsor.
|
Phase II PD-L1-
HER2-positive, PD-L1 negative, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy. The Phase II portion of the trial used a flat dose of 200 mg of MK-3475 based on emerging data from the sponsor.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
40
|
12
|
|
Overall Study
COMPLETED
|
3
|
3
|
37
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Anti-PD-1 Monoclonal Antibody in Advanced, Trastuzumab-resistant, HER2-positive Breast Cancer
Baseline characteristics by cohort
| Measure |
Phase Ib
n=6 Participants
HER2-positive, PD-L1 expressing, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy
|
Phase II PD-L1+
n=40 Participants
HER2-positive, PD-L1 expressing, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy
|
Phase II PD-L1-
n=12 Participants
HER2-positive, PD-L1 negative, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
48 years
STANDARD_DEVIATION 9.5 • n=99 Participants
|
51.2 years
STANDARD_DEVIATION 10.4 • n=107 Participants
|
54.5 years
STANDARD_DEVIATION 5.2 • n=206 Participants
|
51.5 years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
58 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
4 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
42 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Missing
|
2 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
|
Region of Enrollment
Austria
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Region of Enrollment
Belgium
|
0 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
|
Region of Enrollment
Italy
|
0 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Region of Enrollment
Australia
|
4 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
21 Participants
n=7 Participants
|
|
Region of Enrollment
France
|
2 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Within the first 21 daysPopulation: Patients enrolled during phase Ib portion, a patient receiving one or more doses of MK-3475 and trastuzumab is considered evaluable.
Determination of dose-limiting toxicity (DLT) which is defined as an adverse event or abnormal laboratory value assessed as suspected to be trial treatment related (possible, probable or definite) and unrelated to disease or disease progression. Toxicities and lab values will be graded according to the NCI CTCAE (v4.0). 1. Any grade-3 or greater non-hematological adverse event lasting at least one week; 2. Any grade-4 hematological toxicity; or, 3. Any adverse event resulting in a delay starting cycle 2 of more than 14 days.
Outcome measures
| Measure |
Phase Ib 2 mg/kg
n=3 Participants
HER2-positive, PD-L1 expressing, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy
|
Phase Ib 10 mg/kg
n=3 Participants
HER2-positive, PD-L1 expressing, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy
|
Phase II PD-L1-
HER2-positive, PD-L1 negative, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy
|
|---|---|---|---|
|
Dose-Limiting Toxicity (DLT) of MK-3475 in Combination With Trastuzumab
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Clinical and radiological tumor assessment will be performed by CT scan or MRI at baseline, at weeks 12, 18 and 24, then every 12 weeks until progression, or 24 weeks after stop of treatment if before progression.Confirmed CR or PR as best overall response. At the time of each restaging, patients will be classified as achieving complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or non-evaluable for response according to RECIST (Version 1.1) criteria.
Outcome measures
| Measure |
Phase Ib 2 mg/kg
n=6 Participants
HER2-positive, PD-L1 expressing, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy
|
Phase Ib 10 mg/kg
n=40 Participants
HER2-positive, PD-L1 expressing, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy
|
Phase II PD-L1-
n=12 Participants
HER2-positive, PD-L1 negative, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy
|
|---|---|---|---|
|
Objective Response Rate (ORR)
|
0.17 proportion of participants
Interval 0.01 to 0.58
|
0.15 proportion of participants
Interval 0.07 to 0.29
|
0.00 proportion of participants
Interval 0.0 to 0.18
|
SECONDARY outcome
Timeframe: From date of first documentation of objective response until first documentation of progressive disease, up to 24 weeks after stop of treatment (=30 months)Population: Patients who achieved objective response
Duration of response (DoR) is defined among patients with objective response (confirmed CR or PR as best overall response) as the interval between dates of first documentation of objective response and first documentation of progressive disease. In the absence of documented progressive disease, follow-up will be censored at date of last disease assessment.
Outcome measures
| Measure |
Phase Ib 2 mg/kg
n=1 Participants
HER2-positive, PD-L1 expressing, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy
|
Phase Ib 10 mg/kg
n=6 Participants
HER2-positive, PD-L1 expressing, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy
|
Phase II PD-L1-
HER2-positive, PD-L1 negative, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy
|
|---|---|---|---|
|
Duration of Response (DoR)
|
23.1 months
|
3.5 months
Interval 2.7 to 999999.0
|
—
|
SECONDARY outcome
Timeframe: From the first trial treatment until first documentation of progressive disease up to 24 weeks after stop of treatment (=30 months)Time to progression (TTP) defined as the interval between the dates of the start of trial treatment and first documentation of progressive disease. In the absence of documented progressive disease, follow-up will be censored at date of last disease assessment
Outcome measures
| Measure |
Phase Ib 2 mg/kg
n=6 Participants
HER2-positive, PD-L1 expressing, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy
|
Phase Ib 10 mg/kg
n=40 Participants
HER2-positive, PD-L1 expressing, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy
|
Phase II PD-L1-
n=12 Participants
HER2-positive, PD-L1 negative, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy
|
|---|---|---|---|
|
Time to Progression (TTP)
|
2.5 months
Interval 1.1 to 2.7
|
2.7 months
Interval 2.6 to 4.9
|
2.5 months
Interval 1.4 to 999999.0
|
SECONDARY outcome
Timeframe: From the start of trial treatment until confirmed CR, PR, or SD lasting for 24 weeks or longerThe proportion of patients with best confirmed RECIST response of CR, PR, or duration of SD of at least 24 weeks (measured from first dose of trial treatment).
Outcome measures
| Measure |
Phase Ib 2 mg/kg
n=6 Participants
HER2-positive, PD-L1 expressing, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy
|
Phase Ib 10 mg/kg
n=40 Participants
HER2-positive, PD-L1 expressing, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy
|
Phase II PD-L1-
n=12 Participants
HER2-positive, PD-L1 negative, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy
|
|---|---|---|---|
|
Disease Control Rate (DCR)
|
0.17 proportion of participants
Interval 0.01 to 0.58
|
0.25 proportion of participants
Interval 0.14 to 0.39
|
0.00 proportion of participants
Interval 0.0 to 0.18
|
SECONDARY outcome
Timeframe: From the date of first treatment dose until documented disease progression or death from any cause. whichever occur first, assessed up to 30 monthsThe interval between the dates of the first dose of trial treatment until first documentation of disease progression or death, whichever occurs first. Patients with new non-breast cancer malignancy must continue to be followed for progression of the original breast cancer. For patients without progression, follow-up is censored at the date of last disease assessment without progression, unless death occurs within 12 weeks following the date last known progression-free, in which case the death will be counted as a PFS event.
Outcome measures
| Measure |
Phase Ib 2 mg/kg
n=6 Participants
HER2-positive, PD-L1 expressing, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy
|
Phase Ib 10 mg/kg
n=40 Participants
HER2-positive, PD-L1 expressing, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy
|
Phase II PD-L1-
n=12 Participants
HER2-positive, PD-L1 negative, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy
|
|---|---|---|---|
|
Progression-Free Survival (PFS)
|
2.5 months
Interval 1.1 to 2.7
|
2.7 months
Interval 2.6 to 4.0
|
2.5 months
Interval 1.4 to 2.7
|
SECONDARY outcome
Timeframe: Time from start of trial treatment to death from any cause, assessed up to 30 monthsOS is defined as the time from the first dose of trial treatment to death from any cause. For patients who are lost to follow-up or who have no documentation of death at the time of final analysis, follow-up is censored at the date of last assessment of vital status. OS at 12 months by Kaplan-Meier estimates.
Outcome measures
| Measure |
Phase Ib 2 mg/kg
n=6 Participants
HER2-positive, PD-L1 expressing, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy
|
Phase Ib 10 mg/kg
n=40 Participants
HER2-positive, PD-L1 expressing, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy
|
Phase II PD-L1-
n=12 Participants
HER2-positive, PD-L1 negative, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy
|
|---|---|---|---|
|
Overall Survival (OS) at 12 Months
|
0.67 proportion of participants
Interval 0.27 to 0.88
|
.65 proportion of participants
Interval 0.5 to 0.76
|
.12 proportion of participants
Interval 0.01 to 0.36
|
Adverse Events
Phase Ib
Serious events: 4 serious events
Other events: 6 other events
Deaths: 4 deaths
Phase II (PD-L1+ and PD-L1-)
Serious events: 25 serious events
Other events: 50 other events
Deaths: 25 deaths
Serious adverse events
| Measure |
Phase Ib
n=6 participants at risk
HER2-positive, PD-L1 expressing, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy. All 6 patients in Phase I were combined when reporting clinical measures for secondary outcomes adverse events for stronger response rates.
|
Phase II (PD-L1+ and PD-L1-)
n=52 participants at risk
HER2-positive, PD-L1 expressing or PD-L1 negative, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy. For adverse events, Phase II cohorts were combined since PD-L1 status does not affect toxicity.
|
|---|---|---|
|
Gastrointestinal disorders
Gastroenteritis
|
16.7%
1/6 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
0.00%
0/52 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
0.00%
0/52 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Cardiac disorders
Takotsubo cardiomyopathy
|
16.7%
1/6 • Number of events 2 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
0.00%
0/52 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
16.7%
1/6 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
0.00%
0/52 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Nervous system disorders
CNS metastases
|
16.7%
1/6 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
0.00%
0/52 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Ear and labyrinth disorders
Vertigo
|
16.7%
1/6 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
0.00%
0/52 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Reproductive system and breast disorders
Disease progression
|
33.3%
2/6 • Number of events 2 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
11.5%
6/52 • Number of events 6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
General disorders
Death
|
33.3%
2/6 • Number of events 2 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
17.3%
9/52 • Number of events 9 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
3.8%
2/52 • Number of events 2 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Reproductive system and breast disorders
Breast infection
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Hepatobiliary disorders
Bile duct dilatation
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Infections and infestations
Catheter-related infection
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Respiratory, thoracic and mediastinal disorders
Plural effusion
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
5.8%
3/52 • Number of events 3 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Vascular disorders
Intracranial hypertension
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Psychiatric disorders
Cognitive disturbance
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Renal and urinary disorders
Acute renal impairment
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
3.8%
2/52 • Number of events 2 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Hepatobiliary disorders
Hepatic hemorrhage
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
5.8%
3/52 • Number of events 3 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Immune system disorders
Lambert-Eaton syndrome
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Investigations
GGT increased
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Nervous system disorders
Neurological paresis
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma multiforme
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Immune system disorders
Autoimmune hepatitis
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
Other adverse events
| Measure |
Phase Ib
n=6 participants at risk
HER2-positive, PD-L1 expressing, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy. All 6 patients in Phase I were combined when reporting clinical measures for secondary outcomes adverse events for stronger response rates.
|
Phase II (PD-L1+ and PD-L1-)
n=52 participants at risk
HER2-positive, PD-L1 expressing or PD-L1 negative, unresectable loco-regional or metastatic breast carcinoma that progressed on prior trastuzumab-based therapy. For adverse events, Phase II cohorts were combined since PD-L1 status does not affect toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
4/6 • Number of events 6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
15.4%
8/52 • Number of events 8 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Blood and lymphatic system disorders
Fever
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Blood and lymphatic system disorders
Reactive thrombocytosis
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Cardiac disorders
Takotsubo cardiomyopathy
|
16.7%
1/6 • Number of events 2 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
0.00%
0/52 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Ear and labyrinth disorders
Hearing impaired
|
16.7%
1/6 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
0.00%
0/52 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Ear and labyrinth disorders
Vertigo
|
16.7%
1/6 • Number of events 3 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
3.8%
2/52 • Number of events 3 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Endocrine disorders
Hyperthyroidism
|
16.7%
1/6 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Endocrine disorders
Hypothyroidism
|
16.7%
1/6 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
3.8%
2/52 • Number of events 2 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Eye disorders
Dry eye
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
3.8%
2/52 • Number of events 2 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Eye disorders
Retinal vascular disorder
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Eye disorders
Visual field defect left lower quadrants
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
3.8%
2/52 • Number of events 3 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Gastrointestinal disorders
Abdominal pain, intermittent
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
9.6%
5/52 • Number of events 6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
2/6 • Number of events 5 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
17.3%
9/52 • Number of events 11 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Gastrointestinal disorders
Dry mouth
|
16.7%
1/6 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
3.8%
2/52 • Number of events 2 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Gastrointestinal disorders
Gastritis
|
16.7%
1/6 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Gastrointestinal disorders
Gastroenteritis
|
16.7%
1/6 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
0.00%
0/52 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
3.8%
2/52 • Number of events 2 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
5.8%
3/52 • Number of events 3 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 2 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
21.2%
11/52 • Number of events 14 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Gastrointestinal disorders
Nausea with weight loss
|
16.7%
1/6 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
0.00%
0/52 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Gastrointestinal disorders
Tongue mycosis
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • Number of events 2 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
5.8%
3/52 • Number of events 4 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
General disorders
Anemia
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
General disorders
Asthenia
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
General disorders
Diaphoresis
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
General disorders
Edema limbs
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
7.7%
4/52 • Number of events 4 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
General disorders
Edema trunk
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
General disorders
Fatigue
|
50.0%
3/6 • Number of events 4 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
30.8%
16/52 • Number of events 23 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
General disorders
Fever
|
16.7%
1/6 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
5.8%
3/52 • Number of events 5 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
General disorders
Flu-like symptoms
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
9.6%
5/52 • Number of events 5 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
General disorders
Hoarseness
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
General disorders
Infusion related reaction
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
General disorders
Left breast tumour bleeding
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
General disorders
Localized edema
|
16.7%
1/6 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
0.00%
0/52 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
General disorders
Malaise
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
3.8%
2/52 • Number of events 4 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
General disorders
Pain
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
11.5%
6/52 • Number of events 10 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Hepatobiliary disorders
Bile duct dilatation
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 2 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Immune system disorders
Autoimmune disorder
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
5.8%
3/52 • Number of events 3 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Infections and infestations
Catheter-related infection
|
16.7%
1/6 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Infections and infestations
Dental
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Infections and infestations
Esophageal infection
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
3.8%
2/52 • Number of events 4 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Infections and infestations
Rhinitis infective
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
5.8%
3/52 • Number of events 4 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Infections and infestations
Sinusitis
|
16.7%
1/6 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Infections and infestations
Skin infection
|
16.7%
1/6 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Infections and infestations
Upper respiratory infection
|
33.3%
2/6 • Number of events 4 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
3.8%
2/52 • Number of events 3 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 3 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Infections and infestations
Yeasts in the stool
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
7.7%
4/52 • Number of events 4 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
5.8%
3/52 • Number of events 4 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
5.8%
3/52 • Number of events 4 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 3 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Investigations
Drug induced liver injury
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Investigations
Ggt increased
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
9.6%
5/52 • Number of events 11 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Investigations
Hypercalcemia
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Investigations
Leucocyte count decreased
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Investigations
Lipase increased
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
5.8%
3/52 • Number of events 6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Investigations
Lymphocyte count decreased
|
16.7%
1/6 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
3.8%
2/52 • Number of events 2 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Investigations
Serum amylase increased
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
5.8%
3/52 • Number of events 3 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Investigations
Weight loss
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
7.7%
4/52 • Number of events 4 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Investigations
White blood cell decreased
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
7.7%
4/52 • Number of events 4 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
5.8%
3/52 • Number of events 3 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
5.8%
3/52 • Number of events 3 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
16.7%
1/6 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
3.8%
2/52 • Number of events 3 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
16.7%
1/6 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
2/6 • Number of events 3 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
11.5%
6/52 • Number of events 6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
5.8%
3/52 • Number of events 5 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
3.8%
2/52 • Number of events 2 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
33.3%
2/6 • Number of events 2 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
0.00%
0/52 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
2/6 • Number of events 2 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
7.7%
4/52 • Number of events 4 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Musculoskeletal and connective tissue disorders
Pain
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Musculoskeletal and connective tissue disorders
Stiffness
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Nervous system disorders
Aphonia
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 2 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
3.8%
2/52 • Number of events 2 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Nervous system disorders
Dysesthesia
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Number of events 3 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
15.4%
8/52 • Number of events 15 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Nervous system disorders
Loss of hand motor traction
|
16.7%
1/6 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
0.00%
0/52 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Nervous system disorders
Memory impairment
|
16.7%
1/6 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Nervous system disorders
Static cerebellar syndrom
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Nervous system disorders
Tremor
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Nervous system disorders
Vasovagal reaction
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
3.8%
2/52 • Number of events 2 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Psychiatric disorders
Insomnia
|
33.3%
2/6 • Number of events 2 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Renal and urinary disorders
Acute renal impairment
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Renal and urinary disorders
UTI
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
3.8%
2/52 • Number of events 2 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
16.7%
1/6 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
0.00%
0/52 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
17.3%
9/52 • Number of events 12 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
3/6 • Number of events 4 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
21.2%
11/52 • Number of events 18 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis: seasonal
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
1/6 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
0.00%
0/52 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
3.8%
2/52 • Number of events 3 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
16.7%
1/6 • Number of events 2 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
0.00%
0/52 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
7.7%
4/52 • Number of events 4 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
3.8%
2/52 • Number of events 2 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Respiratory, thoracic and mediastinal disorders
Viral upper respiratory tract infection
|
16.7%
1/6 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
5.8%
3/52 • Number of events 4 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Skin and subcutaneous tissue disorders
Cutaneous rash
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 7 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Skin and subcutaneous tissue disorders
Cutaneous toxicity on legs and arms
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Skin and subcutaneous tissue disorders
Erysipelas
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 2 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
9.6%
5/52 • Number of events 6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Skin and subcutaneous tissue disorders
Rash - face
|
16.7%
1/6 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
0.00%
0/52 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
16.7%
1/6 • Number of events 2 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
3.8%
2/52 • Number of events 3 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
5.8%
3/52 • Number of events 4 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Skin and subcutaneous tissue disorders
Redness ankle and feet
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Skin and subcutaneous tissue disorders
Shingles
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
11.5%
6/52 • Number of events 12 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Vascular disorders
Intracranial hypertension
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Vascular disorders
Lymphedema
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Vascular disorders
Lymphedema right leg
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/6 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
1.9%
1/52 • Number of events 1 • From the date of signature of informed consent until 30 days after all treatment discontinuation, regardless of whether it was considered related to a medication. AEs were to be reported at the end of every treatment cycle, at the End-of-Treatment visit, and up to 30 days after cessation of trial treatment. Serious adverse event and pregnancy data were to be collected for 90 days following the end of treatment.
Any grade of any observed AE was to be reported on the AE form. There were no specifications of targeted AEs. Symptoms of the targeted cancer were not to be reported as AEs. AEs were categorized and graded according to CTCAE V4.
|
Additional Information
Heidi Roschitzki-Voser
International Breast Cancer Study Group (IBCSG)
Phone: +41 31 511 94 18
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place