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Trial Outcomes & Findings for Neratinib and Paclitaxel With or Without Pertuzumab and Trastuzumab Before Combination Chemotherapy in Treating Patients With Metastatic or Locally Advanced Breast Cancer (NCT NCT03101748)

NCT ID: NCT03101748

Last Updated: 2026-02-12

Results Overview

Dose-limiting toxicities (DLTs) observed during the first two treatment cycles (approximately 6 weeks) among participants receiving escalating doses of neratinib in combination therapy in Cohort I Phase Ib. Participants With ≥1 DLT.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

34 participants

Primary outcome timeframe

From treatment initiation through completion of 2 cycles (approximately 6 weeks)

Results posted on

2026-02-12

Participant Flow

Feb 2018\~ Oct 2021. All recruitment was done at The University of Texas MD Anderson Cancer Center.

43 patients were accrued and assessed for eligibility and 34 patients were assigned to the cohort.

Participant milestones

Participant milestones
Measure
Cohort 1 Phase Ib Dose Level -1
HER2-positive breast cancer patients received neratinib 40 mg daily in combination with paclitaxel, pertuzumab, and trastuzumab.
Cohort 1 Phase Ib Dose Level 0
HER2-positive breast cancer patients received neratinib 80 mg daily in combination with paclitaxel, pertuzumab, and trastuzumab.
Cohort 1 Phase Ib Dose Level 1
HER2-positive breast cancer patients received neratinib 120 mg daily in combination with paclitaxel, pertuzumab, and trastuzumab.
Cohort 1 Phase Ib Dose Level 2
HER2-positive breast cancer patients received neratinib 160 mg daily in combination with paclitaxel, pertuzumab, and trastuzumab.
Cohort 1 Phase Ib Dose Level 3
HER2-positive breast cancer patients received neratinib 200 mg daily in combination with paclitaxel, pertuzumab, and trastuzumab.
Cohort 1 Phase II
HER2-positive inflammatory breast cancer patients received neratinib at the recommended Phase II dose (RP2D) in combination with paclitaxel, pertuzumab, and trastuzumab, followed by doxorubicin and cyclophosphamide.
Cohort 2
HER2-negative, hormone receptor-positive inflammatory breast cancer patients received neratinib 200 mg daily in combination with paclitaxel, followed by doxorubicin and cyclophosphamide.
Overall Study
STARTED
0
2
2
0
0
14
16
Overall Study
COMPLETED
0
1
1
0
0
9
10
Overall Study
NOT COMPLETED
0
1
1
0
0
5
6

Reasons for withdrawal

Reasons for withdrawal
Measure
Cohort 1 Phase Ib Dose Level -1
HER2-positive breast cancer patients received neratinib 40 mg daily in combination with paclitaxel, pertuzumab, and trastuzumab.
Cohort 1 Phase Ib Dose Level 0
HER2-positive breast cancer patients received neratinib 80 mg daily in combination with paclitaxel, pertuzumab, and trastuzumab.
Cohort 1 Phase Ib Dose Level 1
HER2-positive breast cancer patients received neratinib 120 mg daily in combination with paclitaxel, pertuzumab, and trastuzumab.
Cohort 1 Phase Ib Dose Level 2
HER2-positive breast cancer patients received neratinib 160 mg daily in combination with paclitaxel, pertuzumab, and trastuzumab.
Cohort 1 Phase Ib Dose Level 3
HER2-positive breast cancer patients received neratinib 200 mg daily in combination with paclitaxel, pertuzumab, and trastuzumab.
Cohort 1 Phase II
HER2-positive inflammatory breast cancer patients received neratinib at the recommended Phase II dose (RP2D) in combination with paclitaxel, pertuzumab, and trastuzumab, followed by doxorubicin and cyclophosphamide.
Cohort 2
HER2-negative, hormone receptor-positive inflammatory breast cancer patients received neratinib 200 mg daily in combination with paclitaxel, followed by doxorubicin and cyclophosphamide.
Overall Study
Adverse Event
0
0
1
0
0
3
3
Overall Study
Withdrawal by Subject
0
0
0
0
0
1
0
Overall Study
Disease Progression
0
1
0
0
0
1
3

Baseline Characteristics

Neratinib and Paclitaxel With or Without Pertuzumab and Trastuzumab Before Combination Chemotherapy in Treating Patients With Metastatic or Locally Advanced Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Cohort 1 Phase Ib Dose Level -1
HER2-positive breast cancer patients received neratinib 40 mg daily in combination with paclitaxel, pertuzumab, and trastuzumab.
Cohort 1 Phase Ib Dose Level 0
n=2 Participants
HER2-positive breast cancer patients received neratinib 80 mg daily in combination with paclitaxel, pertuzumab, and trastuzumab.
Cohort 1 Phase Ib Dose Level 1
n=2 Participants
HER2-positive breast cancer patients received neratinib 120 mg daily in combination with paclitaxel, pertuzumab, and trastuzumab.
Cohort 1 Phase Ib Dose Level 2
HER2-positive breast cancer patients received neratinib 160 mg daily in combination with paclitaxel, pertuzumab, and trastuzumab.
Cohort 1 Phase Ib Dose Level 3
HER2-positive breast cancer patients received neratinib 200 mg daily in combination with paclitaxel, pertuzumab, and trastuzumab.
Cohort 1 Phase II
n=14 Participants
HER2-positive inflammatory breast cancer patients received neratinib at the recommended Phase II dose (RP2D) in combination with paclitaxel, pertuzumab, and trastuzumab, followed by doxorubicin and cyclophosphamide.
Cohort 2
n=16 Participants
HER2-negative, hormone receptor-positive inflammatory breast cancer patients received neratinib 200 mg daily in combination with paclitaxel, followed by doxorubicin and cyclophosphamide.
Total
n=34 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=41 Participants
0 Participants
n=1581 Participants
0 Participants
n=4626 Participants
0 Participants
n=72 Participants
0 Participants
0 Participants
n=140 Participants
0 Participants
n=69 Participants
0 Participants
n=4 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=41 Participants
2 Participants
n=1581 Participants
2 Participants
n=4626 Participants
0 Participants
n=72 Participants
0 Participants
12 Participants
n=140 Participants
16 Participants
n=69 Participants
32 Participants
n=4 Participants
Age, Categorical
>=65 years
0 Participants
n=41 Participants
0 Participants
n=1581 Participants
0 Participants
n=4626 Participants
0 Participants
n=72 Participants
0 Participants
2 Participants
n=140 Participants
0 Participants
n=69 Participants
2 Participants
n=4 Participants
Sex: Female, Male
Female
—
2 Participants
n=1581 Participants
2 Participants
n=4626 Participants
—
—
14 Participants
n=140 Participants
16 Participants
n=69 Participants
34 Participants
n=4 Participants
Sex: Female, Male
Male
—
0 Participants
n=1581 Participants
0 Participants
n=4626 Participants
—
—
0 Participants
n=140 Participants
0 Participants
n=69 Participants
0 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
—
0 Participants
n=1581 Participants
0 Participants
n=4626 Participants
—
—
4 Participants
n=140 Participants
2 Participants
n=69 Participants
6 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
—
2 Participants
n=1581 Participants
2 Participants
n=4626 Participants
—
—
10 Participants
n=140 Participants
13 Participants
n=69 Participants
27 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
—
0 Participants
n=1581 Participants
0 Participants
n=4626 Participants
—
—
0 Participants
n=140 Participants
1 Participants
n=69 Participants
1 Participants
n=4 Participants
Race (NIH/OMB)
American Indian or Alaska Native
—
0 Participants
n=1581 Participants
0 Participants
n=4626 Participants
—
—
1 Participants
n=140 Participants
0 Participants
n=69 Participants
1 Participants
n=4 Participants
Race (NIH/OMB)
Asian
—
1 Participants
n=1581 Participants
0 Participants
n=4626 Participants
—
—
0 Participants
n=140 Participants
1 Participants
n=69 Participants
2 Participants
n=4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
—
0 Participants
n=1581 Participants
0 Participants
n=4626 Participants
—
—
0 Participants
n=140 Participants
0 Participants
n=69 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Black or African American
—
0 Participants
n=1581 Participants
0 Participants
n=4626 Participants
—
—
1 Participants
n=140 Participants
2 Participants
n=69 Participants
3 Participants
n=4 Participants
Race (NIH/OMB)
White
—
1 Participants
n=1581 Participants
2 Participants
n=4626 Participants
—
—
12 Participants
n=140 Participants
11 Participants
n=69 Participants
26 Participants
n=4 Participants
Race (NIH/OMB)
More than one race
—
0 Participants
n=1581 Participants
0 Participants
n=4626 Participants
—
—
0 Participants
n=140 Participants
2 Participants
n=69 Participants
2 Participants
n=4 Participants
Race (NIH/OMB)
Unknown or Not Reported
—
0 Participants
n=1581 Participants
0 Participants
n=4626 Participants
—
—
0 Participants
n=140 Participants
0 Participants
n=69 Participants
0 Participants
n=4 Participants
Region of Enrollment
United States
—
2 participants
n=1581 Participants
2 participants
n=4626 Participants
—
—
14 participants
n=140 Participants
16 participants
n=69 Participants
34 participants
n=4 Participants

PRIMARY outcome

Timeframe: From treatment initiation through completion of 2 cycles (approximately 6 weeks)

Population: No participants enrolled on Cohort 1 Phase Ib Dose Level -1, Cohort 1 Phase Ib Dose Level 2, or Cohort 1 Phase Ib Dose Level 3

Dose-limiting toxicities (DLTs) observed during the first two treatment cycles (approximately 6 weeks) among participants receiving escalating doses of neratinib in combination therapy in Cohort I Phase Ib. Participants With ≥1 DLT.

Outcome measures

Outcome measures
Measure
Cohort 1 Phase Ib Dose Level -1
HER2-positive breast cancer patients received neratinib 40 mg daily in combination with paclitaxel, pertuzumab, and trastuzumab.
Cohort 1 Phase Ib Dose Level 0
n=2 Participants
HER2-positive breast cancer patients received neratinib 80 mg daily in combination with paclitaxel, pertuzumab, and trastuzumab.
Cohort 1 Phase Ib Dose Level 1
n=2 Participants
HER2-positive breast cancer patients received neratinib 120 mg daily in combination with paclitaxel, pertuzumab, and trastuzumab.
Cohort 1 Phase Ib Dose Level 2
HER2-positive breast cancer patients received neratinib 160 mg daily in combination with paclitaxel, pertuzumab, and trastuzumab.
Cohort 1 Phase Ib Dose Level 3
HER2-positive breast cancer patients received neratinib 200 mg daily in combination with paclitaxel, pertuzumab, and trastuzumab.
Dose-Limiting Toxicities (DLTs) During Dose Escalation
—
0 Participants
2 Participants
—
—

PRIMARY outcome

Timeframe: At surgery following completion of neoadjuvant therapy (approximately 18-24 weeks from treatment initiation).

Population: All patients who initiated protocol treatment were included in the intent-to-treat (ITT) population in Cohort I Phase II.

Pathologic complete response (pCR) was defined as no residual invasive cancer in the breast and sampled lymph nodes at surgery (ypT0/Tis, ypN0). The primary analysis was conducted using the intent-to-treat (ITT) population; participants who did not undergo surgery were counted as non-pCR.

Outcome measures

Outcome measures
Measure
Cohort 1 Phase Ib Dose Level -1
n=14 Participants
HER2-positive breast cancer patients received neratinib 40 mg daily in combination with paclitaxel, pertuzumab, and trastuzumab.
Cohort 1 Phase Ib Dose Level 0
HER2-positive breast cancer patients received neratinib 80 mg daily in combination with paclitaxel, pertuzumab, and trastuzumab.
Cohort 1 Phase Ib Dose Level 1
HER2-positive breast cancer patients received neratinib 120 mg daily in combination with paclitaxel, pertuzumab, and trastuzumab.
Cohort 1 Phase Ib Dose Level 2
HER2-positive breast cancer patients received neratinib 160 mg daily in combination with paclitaxel, pertuzumab, and trastuzumab.
Cohort 1 Phase Ib Dose Level 3
HER2-positive breast cancer patients received neratinib 200 mg daily in combination with paclitaxel, pertuzumab, and trastuzumab.
Pathologic Complete Response (pCR) in HER2+ Metastatic or Locally Advanced IBC in Cohort I Phase II
5 Participants
—
—
—
—

PRIMARY outcome

Timeframe: At the time of surgery (mastectomy), following completion of neoadjuvant therapy; approximately 18-24 weeks from treatment initiation.

Population: All patients who initiated protocol treatment were included in the intent-to-treat (ITT) population in Cohort II.

Pathologic complete response (pCR) was defined as no residual invasive cancer in the breast and sampled lymph nodes at surgery (ypT0/Tis, ypN0). The primary analysis was conducted using the intent-to-treat (ITT) population; participants who did not undergo surgery were counted as non-pCR.

Outcome measures

Outcome measures
Measure
Cohort 1 Phase Ib Dose Level -1
n=16 Participants
HER2-positive breast cancer patients received neratinib 40 mg daily in combination with paclitaxel, pertuzumab, and trastuzumab.
Cohort 1 Phase Ib Dose Level 0
HER2-positive breast cancer patients received neratinib 80 mg daily in combination with paclitaxel, pertuzumab, and trastuzumab.
Cohort 1 Phase Ib Dose Level 1
HER2-positive breast cancer patients received neratinib 120 mg daily in combination with paclitaxel, pertuzumab, and trastuzumab.
Cohort 1 Phase Ib Dose Level 2
HER2-positive breast cancer patients received neratinib 160 mg daily in combination with paclitaxel, pertuzumab, and trastuzumab.
Cohort 1 Phase Ib Dose Level 3
HER2-positive breast cancer patients received neratinib 200 mg daily in combination with paclitaxel, pertuzumab, and trastuzumab.
Pathologic Complete Response (pCR) in HER2-Negative / HR-Positive IBC in Cohort II
1 Participants
—
—
—
—

SECONDARY outcome

Timeframe: From treatment initiation to 2 years after start of therapy.

Population: All patients who initiated protocol treatment were included.

Event-free survival (EFS) was defined as the time from treatment initiation to the first occurrence of disease progression, recurrence, or death from any cause. EFS rates at 2 years were estimated using the Kaplan-Meier method; participants without an event were censored at last disease assessment.

Outcome measures

Outcome measures
Measure
Cohort 1 Phase Ib Dose Level -1
n=14 Participants
HER2-positive breast cancer patients received neratinib 40 mg daily in combination with paclitaxel, pertuzumab, and trastuzumab.
Cohort 1 Phase Ib Dose Level 0
n=16 Participants
HER2-positive breast cancer patients received neratinib 80 mg daily in combination with paclitaxel, pertuzumab, and trastuzumab.
Cohort 1 Phase Ib Dose Level 1
HER2-positive breast cancer patients received neratinib 120 mg daily in combination with paclitaxel, pertuzumab, and trastuzumab.
Cohort 1 Phase Ib Dose Level 2
HER2-positive breast cancer patients received neratinib 160 mg daily in combination with paclitaxel, pertuzumab, and trastuzumab.
Cohort 1 Phase Ib Dose Level 3
HER2-positive breast cancer patients received neratinib 200 mg daily in combination with paclitaxel, pertuzumab, and trastuzumab.
Event-Free Survival (EFS) Rate at 2 Years
84.6 percentage of participants
Interval 67.1 to 100.0
68.2 percentage of participants
Interval 48.6 to 95.7
—
—
—

Adverse Events

Cohort 1 Phase Ib Dose Level 0

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

Cohort 1 Phase Ib Dose Level 1

Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths

Cohort 1 Phase II

Serious events: 6 serious events
Other events: 14 other events
Deaths: 2 deaths

Cohort 2

Serious events: 3 serious events
Other events: 16 other events
Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure
Cohort 1 Phase Ib Dose Level 0
n=2 participants at risk
HER2-positive breast cancer patients received neratinib 80 mg daily in combination with paclitaxel, pertuzumab, and trastuzumab.
Cohort 1 Phase Ib Dose Level 1
n=2 participants at risk
HER2-positive breast cancer patients received neratinib 120 mg daily in combination with paclitaxel, pertuzumab, and trastuzumab.
Cohort 1 Phase II
n=14 participants at risk
HER2-positive inflammatory breast cancer patients received neratinib at the recommended Phase II dose (RP2D) in combination with paclitaxel, pertuzumab, and trastuzumab, followed by doxorubicin and cyclophosphamide.
Cohort 2
n=16 participants at risk
HER2-negative, hormone receptor-positive inflammatory breast cancer patients received neratinib 200 mg daily in combination with paclitaxel, followed by doxorubicin and cyclophosphamide.
General disorders
Fever
50.0%
1/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Blood and lymphatic system disorders
Febrile neutropenia
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
50.0%
1/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Infections and infestations
Urinary tract Infection
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
50.0%
1/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Gastrointestinal disorders
Nausea
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
50.0%
1/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
14.3%
2/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Gastrointestinal disorders
Diarrhea
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
50.0%
1/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Gastrointestinal disorders
Vomiting
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
50.0%
1/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
14.3%
2/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Gastrointestinal disorders
Ileus
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
50.0%
1/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Metabolism and nutrition disorders
Dehydration
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
50.0%
1/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Renal and urinary disorders
Acute kidney injury
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
6.2%
1/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
General disorders
Edema limbs
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Respiratory, thoracic and mediastinal disorders
Dyspnea
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Infections and infestations
Breast Infection
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
6.2%
1/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
General disorders
Fatigue
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Metabolism and nutrition disorders
Hypokalemia
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Investigations
BUN Increased "
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Renal and urinary disorders
Creatinine Increased
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
14.3%
2/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Musculoskeletal and connective tissue disorders
Flank pain
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Renal and urinary disorders
Urinary retention
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Renal and urinary disorders
Urine output decreased
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Renal and urinary disorders
Renal Stone
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Renal and urinary disorders
Acute Kidney Injury
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Infections and infestations
Lung Infection
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Respiratory, thoracic and mediastinal disorders
Pneumothorax
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
6.2%
1/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.

Other adverse events

Other adverse events
Measure
Cohort 1 Phase Ib Dose Level 0
n=2 participants at risk
HER2-positive breast cancer patients received neratinib 80 mg daily in combination with paclitaxel, pertuzumab, and trastuzumab.
Cohort 1 Phase Ib Dose Level 1
n=2 participants at risk
HER2-positive breast cancer patients received neratinib 120 mg daily in combination with paclitaxel, pertuzumab, and trastuzumab.
Cohort 1 Phase II
n=14 participants at risk
HER2-positive inflammatory breast cancer patients received neratinib at the recommended Phase II dose (RP2D) in combination with paclitaxel, pertuzumab, and trastuzumab, followed by doxorubicin and cyclophosphamide.
Cohort 2
n=16 participants at risk
HER2-negative, hormone receptor-positive inflammatory breast cancer patients received neratinib 200 mg daily in combination with paclitaxel, followed by doxorubicin and cyclophosphamide.
Gastrointestinal disorders
Abdominal pain
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
6.2%
1/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Renal and urinary disorders
Acute Kidney Injury
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
50.0%
1/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Skin and subcutaneous tissue disorders
Alopecia
50.0%
1/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
50.0%
1/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
100.0%
14/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
87.5%
14/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Blood and lymphatic system disorders
Anemia
50.0%
1/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
21.4%
3/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
6.2%
1/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Metabolism and nutrition disorders
Anorexia
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
50.0%
1/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
6.2%
1/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Psychiatric disorders
Anxiety
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
12.5%
2/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
12.5%
2/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Gastrointestinal disorders
Ascites
50.0%
1/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Musculoskeletal and connective tissue disorders
Back Pain
50.0%
1/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
6.2%
1/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Renal and urinary disorders
Bladder spasm
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Infections and infestations
Breast Infection
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
6.2%
1/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Reproductive system and breast disorders
Breast Pain
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
12.5%
2/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Nervous system disorders
Concentration Impairment
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
6.2%
1/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Infections and infestations
Conjunctivitis
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Gastrointestinal disorders
Constipation
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
18.8%
3/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Metabolism and nutrition disorders
Dehydration
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
14.3%
2/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
6.2%
1/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Psychiatric disorders
Depression
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
6.2%
1/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Gastrointestinal disorders
Diarrhea
100.0%
2/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
100.0%
2/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
100.0%
14/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
93.8%
15/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Gastrointestinal disorders
Dyspepsia
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
25.0%
4/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Respiratory, thoracic and mediastinal disorders
Dyspnea
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Renal and urinary disorders
Dysuria
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
21.4%
3/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
6.2%
1/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Ear and labyrinth disorders
Ear pain
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Investigations
Electrocardiogram QT corrected interval prolonged
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Eye disorders
Syte
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
General disorders
Fatigue
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
100.0%
2/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
64.3%
9/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
50.0%
8/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
General disorders
Fever
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
50.0%
1/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
6.2%
1/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Musculoskeletal and connective tissue disorders
Flank pain
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Nervous system disorders
Headache
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
6.2%
1/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Gastrointestinal disorders
Hemorrhoidal hemorrhage
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
6.2%
1/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Gastrointestinal disorders
Hemorrhoids
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
6.2%
1/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Vascular disorders
Hot flashes
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
21.4%
3/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
12.5%
2/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Vascular disorders
Hypertension
50.0%
1/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
21.4%
3/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
18.8%
3/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Vascular disorders
Hypotension
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
6.2%
1/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Infections and infestations
COVID-19 or SARS-CoV-2 infection
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
6.2%
1/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Injury, poisoning and procedural complications
Infusion related reaction
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
21.4%
3/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
18.8%
3/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Psychiatric disorders
Insomnia
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
6.2%
1/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
General disorders
Localized edema
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
50.0%
1/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
6.2%
1/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Infections and infestations
Lung Infection
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Investigations
Lymphocyte count decreased
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
6.2%
1/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Infections and infestations
Mucosal infection
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Gastrointestinal disorders
Mucositis Oral
50.0%
1/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
50.0%
1/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
35.7%
5/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
6.2%
1/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
21.4%
3/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
6.2%
1/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Skin and subcutaneous tissue disorders
Nail discoloration
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Infections and infestations
Nail Infection
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
50.0%
1/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Skin and subcutaneous tissue disorders
Nail loss
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
28.6%
4/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
6.2%
1/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Gastrointestinal disorders
Nausea
50.0%
1/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
50.0%
1/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
92.9%
13/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
43.8%
7/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Investigations
Neutrophil count decreased
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
50.0%
1/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
14.3%
2/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
12.5%
2/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Infections and infestations
Otitis media
50.0%
1/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
General disorders
Pain
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
14.3%
2/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
12.5%
2/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
6.2%
1/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Nervous system disorders
Paresthesia
50.0%
1/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
50.0%
1/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
21.4%
3/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
12.5%
2/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Infections and infestations
Paronychia
100.0%
2/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Nervous system disorders
Peripheral sensory neuropathy
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
6.2%
1/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Nervous system disorders
Presyncope
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
12.5%
2/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Skin and subcutaneous tissue disorders
Pruritus
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
6.2%
1/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Vascular disorders
Pulmonary embolism
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Skin and subcutaneous tissue disorders
Rash
50.0%
1/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
50.0%
1/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
50.0%
7/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
31.2%
5/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Renal and urinary disorders
Renal calculi
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
14.3%
2/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Infections and infestations
Sinusitis
50.0%
1/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Infections and infestations
Skin infection
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
6.2%
1/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Respiratory, thoracic and mediastinal disorders
Sore throat
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Vascular disorders
Thromboembolic event
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
6.2%
1/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Infections and infestations
Tooth infection
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
12.5%
2/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Gastrointestinal disorders
Toothache
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
12.5%
2/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Infections and infestations
Upper respiratory infection
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
21.4%
3/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Renal and urinary disorders
Urinary frequency
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
21.4%
3/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Renal and urinary disorders
Urinary retention
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Infections and infestations
Urinary Tract Infection
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
14.3%
2/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
18.8%
3/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Renal and urinary disorders
Urinary urgency
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
35.7%
5/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Investigations
Urine output decreased
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Infections and infestations
Vaginal Infection
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
6.2%
1/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Reproductive system and breast disorders
Vaginal Pain
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Nervous system disorders
Vasovagal reaction
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
6.2%
1/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Gastrointestinal disorders
Vomiting
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
57.1%
8/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
25.0%
4/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Investigations
Weight gain
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
50.0%
1/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
12.5%
2/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Investigations
Weight loss
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
28.6%
4/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
25.0%
4/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Investigations
White blood cell decreased
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
50.0%
1/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
7.1%
1/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
6.2%
1/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Injury, poisoning and procedural complications
Wound dehiscence
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
6.2%
1/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
Infections and infestations
Fungal infection
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/2 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
0.00%
0/14 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
6.2%
1/16 • All-Cause Mortality was assessed for 2 years after treatment discontinuation, up to 3 years; all Adverse Events were collected from the time of the first protocol-specific intervention until 30 days after the last dose of drug, up to 1 year
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.

Additional Information

Rachel Layman, MD

The University of Texas MD Anderson Cancer Center

Phone: (713) 745-8401

Results disclosure agreements

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