Trial Outcomes & Findings for A Study of IMGN901 for Patients With Advanced Solid Tumors and Extensive Stage Small Cell Lung Cancer (NCT NCT01237678)
NCT ID: NCT01237678
Last Updated: 2018-01-18
Results Overview
The primary outcome measure for Phase I was to determine the maximum tolerated dose (MTD) and characterize the dose limiting toxicities (DLT) of IMGN901 when administered in combination with carboplatin/etoposide chemotherapy followed by IMGN901 alone in patients with solid tumors. For the purposes of dose escalation and determination of MTD, DLTs were defined as AEs or abnormal laboratory values related to study treatment which occurred in Cycle 1 of the Dose Escalation phase, including any AEs that resulted in failure to meet the criteria for re-treatment. The following events were considered DLTs (using the most current version of CTCAE): febrile neutropenia; Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding; ≥ Grade 3 peripheral neuropathy; ≥ Grade 3 vomiting, nausea, or diarrhea that persisted despite the use of optimal therapy; other ≥ grade 3 non-hematologic toxicity (with the exception of brief fatigue i.e. ≤ 72 hours and alopecia)
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
181 participants
Primary outcome timeframe
21 days (Cycle 1)
Results posted on
2018-01-18
Participant Flow
Participants were recruited from, and treated at, 45 study sites in the U.S., Canada, Spain, and the U.K. between November 2010 and May 2015.
Patients were screened during a 28-day period
Participant milestones
| Measure |
Phase I - IMGN901 + Carboplatin + Etoposide
Participants received IMGN901 on Days 1 and 8 of a 21-day cycle. All patients also received carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle.The starting dose of IMGN901 was 60 mg/m2; dose escalation proceeded, as tolerated, through 75, 90, and 112 mg/m2. Carboplatin was originally dosed at an AUC 6 however due to poor tolerability this was reduced to an AUC of 5. Study drug combinations were administered for four cycles, with up to 6 cycles allowed. IMGN901 was continued as monotherapy for patients who achieved a response or stable disease.
|
Phase II - IMGN901 + Carboplatin + Etoposide
IMGN901 was administered at the RP2D (recommended phase II dose) determined in Phase I (112 mg/m2; later reduced to 90 mg/m2) on Days 1 and 8 of each 21-day cycle. Patients also received carboplatin (AUC 5) on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. Study drug combinations were administered for four cycles, with up to 6 cycles allowed. IMGN901 was continued as monotherapy for patients who achieved a response or stable disease.
|
Phase II - Carboplatin + Etoposide
Carboplatin (AUC 5) was administered on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. Drugs were administered for 6 cycles as tolerated.
|
|---|---|---|---|
|
Phase I - IMGN901+Carboplatin+Etoposide
STARTED
|
33
|
0
|
0
|
|
Phase I - IMGN901+Carboplatin+Etoposide
Received Intervention
|
33
|
0
|
0
|
|
Phase I - IMGN901+Carboplatin+Etoposide
COMPLETED
|
0
|
0
|
0
|
|
Phase I - IMGN901+Carboplatin+Etoposide
NOT COMPLETED
|
33
|
0
|
0
|
|
Phase II
STARTED
|
0
|
98
|
50
|
|
Phase II
Received Intervention
|
0
|
94
|
47
|
|
Phase II
COMPLETED
|
0
|
0
|
0
|
|
Phase II
NOT COMPLETED
|
0
|
98
|
50
|
Reasons for withdrawal
| Measure |
Phase I - IMGN901 + Carboplatin + Etoposide
Participants received IMGN901 on Days 1 and 8 of a 21-day cycle. All patients also received carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle.The starting dose of IMGN901 was 60 mg/m2; dose escalation proceeded, as tolerated, through 75, 90, and 112 mg/m2. Carboplatin was originally dosed at an AUC 6 however due to poor tolerability this was reduced to an AUC of 5. Study drug combinations were administered for four cycles, with up to 6 cycles allowed. IMGN901 was continued as monotherapy for patients who achieved a response or stable disease.
|
Phase II - IMGN901 + Carboplatin + Etoposide
IMGN901 was administered at the RP2D (recommended phase II dose) determined in Phase I (112 mg/m2; later reduced to 90 mg/m2) on Days 1 and 8 of each 21-day cycle. Patients also received carboplatin (AUC 5) on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. Study drug combinations were administered for four cycles, with up to 6 cycles allowed. IMGN901 was continued as monotherapy for patients who achieved a response or stable disease.
|
Phase II - Carboplatin + Etoposide
Carboplatin (AUC 5) was administered on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. Drugs were administered for 6 cycles as tolerated.
|
|---|---|---|---|
|
Phase I - IMGN901+Carboplatin+Etoposide
Adverse Event
|
5
|
0
|
0
|
|
Phase I - IMGN901+Carboplatin+Etoposide
Lack of Efficacy
|
24
|
0
|
0
|
|
Phase I - IMGN901+Carboplatin+Etoposide
Withdrawal by Subject
|
3
|
0
|
0
|
|
Phase I - IMGN901+Carboplatin+Etoposide
Incorrect Original Diagnosis
|
1
|
0
|
0
|
|
Phase II
Adverse Event
|
0
|
39
|
9
|
|
Phase II
Death
|
0
|
0
|
2
|
|
Phase II
Lack of Efficacy
|
0
|
25
|
3
|
|
Phase II
Withdrawal by Subject
|
0
|
1
|
5
|
|
Phase II
Completed Cycles 4-6
|
0
|
11
|
21
|
|
Phase II
Sponsor Decision/Study Closed
|
0
|
18
|
7
|
|
Phase II
Randomized but were not treated
|
0
|
4
|
3
|
Baseline Characteristics
A Study of IMGN901 for Patients With Advanced Solid Tumors and Extensive Stage Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Phase I - IMGN901 + Carboplatin + Etoposide
n=33 Participants
Participants received IMGN901 on Days 1 and 8 of a 21-day cycle. All patients also received carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle.The starting dose of IMGN901 was 60 mg/m2; dose escalation proceeded, as tolerated, through 75, 90, and 112 mg/m2. Carboplatin was originally dosed at an AUC 6 however due to poor tolerability this was reduced to an AUC of 5. Study drug combinations were administered for four cycles, with up to 6 cycles allowed. IMGN901 was continued as monotherapy for patients who achieved a response or stable disease.
|
Phase II - IMGN901 + Carboplatin + Etoposide
n=94 Participants
IMGN901 was administered at the RP2D determined in Phase I (112 mg/m2; later reduced to 90 mg/m2) on Days 1 and 8 of each 21-day cycle. Patients also received carboplatin (AUC 5) on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. Study drug combinations were administered for four cycles, with up to 6 cycles allowed. IMGN901 was continued as monotherapy for patients who achieved a response or stable disease.
|
Phase II - Carboplatin + Etoposide
n=47 Participants
Carboplatin (AUC 5) was administered on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. Drugs were administered for 6 cycles as tolerated.
|
Total
n=174 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
96 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
78 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
82 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
92 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=99 Participants
|
90 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
164 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
14 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
48 Participants
n=7 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1
|
19 Participants
n=99 Participants
|
62 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
113 Participants
n=7 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
2
|
0 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
|
History of Smoking
Yes
|
21 participants
n=99 Participants
|
93 participants
n=107 Participants
|
46 participants
n=206 Participants
|
160 participants
n=7 Participants
|
|
History of Smoking
No
|
12 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
14 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 21 days (Cycle 1)Population: A total of 33 patients were analyzed as part of the Dose escalation phase.
The primary outcome measure for Phase I was to determine the maximum tolerated dose (MTD) and characterize the dose limiting toxicities (DLT) of IMGN901 when administered in combination with carboplatin/etoposide chemotherapy followed by IMGN901 alone in patients with solid tumors. For the purposes of dose escalation and determination of MTD, DLTs were defined as AEs or abnormal laboratory values related to study treatment which occurred in Cycle 1 of the Dose Escalation phase, including any AEs that resulted in failure to meet the criteria for re-treatment. The following events were considered DLTs (using the most current version of CTCAE): febrile neutropenia; Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding; ≥ Grade 3 peripheral neuropathy; ≥ Grade 3 vomiting, nausea, or diarrhea that persisted despite the use of optimal therapy; other ≥ grade 3 non-hematologic toxicity (with the exception of brief fatigue i.e. ≤ 72 hours and alopecia)
Outcome measures
| Measure |
IMGN901 60 mg/m2 + Carboplatin AUC 6 + Etoposide 100 mg/m2
n=6 Participants
|
IMGN901 75 mg/m2 + Carboplatin AUC 6 + Etoposide 100 mg/m2
n=6 Participants
|
IMGN901 75 mg/m2 + Carboplatin AUC 5 + Etoposide 100 mg/m2
n=3 Participants
|
IMGN901 90 mg/m2 + Carboplatin AUC 5 + Etoposide 100 mg/m2
n=6 Participants
|
IMGN901 112 mg/m2 + Carboplatin AUC 5 + Etoposide 100 mg/m2
n=12 Participants
|
|---|---|---|---|---|---|
|
Occurrence of Dose Limiting Toxicities (DLT)
Grade 3 febrile neutropenia
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Occurrence of Dose Limiting Toxicities (DLT)
Grade 4 febrile neutropenia
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Occurrence of Dose Limiting Toxicities (DLT)
Grade 3 lobar pneumonia
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Occurrence of Dose Limiting Toxicities (DLT)
Grade 4 thrombocytopenia
|
0 participants
|
2 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Occurrence of Dose Limiting Toxicities (DLT)
Grade 4 granulocytopenia
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: From randomization to objective tumor progression or death (up to post-treatment follow-up 28 days after last dose, up to 22 months)Population: A total of 82 patients from the IMGN901 + carboplatin + etoposide safety population (N=94) were included in the efficacy analyses, due to the lack of post-baseline evaluations for 12 participants.
The primary outcome measure for Phase II was to determine the efficacy of IMGN901 in combination with carboplatin/etoposide chemotherapy as first-line treatment for patients with extensive stage small cell lung cancer. PFS was defined as the time from enrollment until objective tumor progression according to RECIST 1.1 or death on study due to any cause, whichever occurred first. Only the results from the experimental arm (IMGN901 + carboplatin + etoposide) are presented as the primary objective of this phase of the study was to compare PFS in the experimental arm (triplet combination) against historical PFS rates for carboplatin and etoposide. The control arm was planned primarily to reliably assess the safety of IMGN901 and to demonstrate whether the or not the historical assumptions regarding efficacy were confirmed.
Outcome measures
| Measure |
IMGN901 60 mg/m2 + Carboplatin AUC 6 + Etoposide 100 mg/m2
n=82 Participants
|
IMGN901 75 mg/m2 + Carboplatin AUC 6 + Etoposide 100 mg/m2
|
IMGN901 75 mg/m2 + Carboplatin AUC 5 + Etoposide 100 mg/m2
|
IMGN901 90 mg/m2 + Carboplatin AUC 5 + Etoposide 100 mg/m2
|
IMGN901 112 mg/m2 + Carboplatin AUC 5 + Etoposide 100 mg/m2
|
|---|---|---|---|---|---|
|
Progression Free Survival (PFS) in Phase II
|
6.2 months
Interval 5.4 to 7.2
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 21 days (Cycle 1)Population: During escalation, carboplatin dosing was reduced from AUC 6 to AUC 5 due to poor tolerability; therefore the MTD for IMGN901 was determined in combination with carboplatin AUC5 and 100 mg/m\^2 etoposide
A primary outcome measure for Phase I was to determine the maximum tolerated dose (MTD) of IMGN901 when administered in combination with carboplatin/etoposide chemotherapy followed by IMGN901 alone in patients with solid tumors. The MTD was determined based on DLTs that occurred during Cycle 1.
Outcome measures
| Measure |
IMGN901 60 mg/m2 + Carboplatin AUC 6 + Etoposide 100 mg/m2
n=33 Participants
|
IMGN901 75 mg/m2 + Carboplatin AUC 6 + Etoposide 100 mg/m2
|
IMGN901 75 mg/m2 + Carboplatin AUC 5 + Etoposide 100 mg/m2
|
IMGN901 90 mg/m2 + Carboplatin AUC 5 + Etoposide 100 mg/m2
|
IMGN901 112 mg/m2 + Carboplatin AUC 5 + Etoposide 100 mg/m2
|
|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of IMGN901
|
112 mg/m^2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment (up to 22 months)To assess the type and frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs). An AE was defined as any noxious, pathologic, or unintended change un anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of the study, whether or not deemed study drug-related. An SAE was any AE resulting in death, life-threatening experience, initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, or congenital defect. All AEs were reported from the time of the first dose of study treatment until 28 days after the final dose of study drug. the severity of AEs were graded by the Investigator using National cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) version 4.0.
Outcome measures
| Measure |
IMGN901 60 mg/m2 + Carboplatin AUC 6 + Etoposide 100 mg/m2
n=33 Participants
|
IMGN901 75 mg/m2 + Carboplatin AUC 6 + Etoposide 100 mg/m2
n=94 Participants
|
IMGN901 75 mg/m2 + Carboplatin AUC 5 + Etoposide 100 mg/m2
n=47 Participants
|
IMGN901 90 mg/m2 + Carboplatin AUC 5 + Etoposide 100 mg/m2
|
IMGN901 112 mg/m2 + Carboplatin AUC 5 + Etoposide 100 mg/m2
|
|---|---|---|---|---|---|
|
Overview of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Any TEAE
|
33 participants
|
94 participants
|
46 participants
|
—
|
—
|
|
Overview of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Related TEAE
|
32 participants
|
90 participants
|
39 participants
|
—
|
—
|
|
Overview of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Any SAE
|
16 participants
|
54 participants
|
23 participants
|
—
|
—
|
|
Overview of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Related SAE
|
8 participants
|
30 participants
|
9 participants
|
—
|
—
|
|
Overview of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs leading to discontinuation
|
8 participants
|
50 participants
|
6 participants
|
—
|
—
|
|
Overview of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Any Grade ≥ 3 TEAE
|
29 participants
|
92 participants
|
42 participants
|
—
|
—
|
|
Overview of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Related Grade ≥ 3 TEAE
|
22 participants
|
83 participants
|
33 participants
|
—
|
—
|
|
Overview of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Deaths within 28 days of last dose
|
1 participants
|
14 participants
|
5 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: A total of 82 patients from the IMGN901 + carboplatin + etoposide safety population (N=94) were included in the efficacy analyses, due to the lack of post-baseline evaluations for 12 participants.
The trial was not empowered to permit a statistically informative comparison of the randomized treatment groups with respect to PFS. The activity of IMGN901 was assessed by comparing the PFS rate at 6 months in the IMGN901 experimental arm against the historical 6-month PFS rate of 0.44 (equivalently a median PFS = 5 months). Only the results from the experimental arm (IMGN901 + carboplatin + etoposide) are presented as the objective was to compare PFS at 6 months in the experimental arm (triplet combination) against the historical PFS rate of 0.44 (equivalently a median PFS = 5 months) for carboplatin and etoposide. The control arm was planned primarily to reliably assess the safety of IMGN901 and to demonstrate whether the or not the historical assumptions regarding efficacy were confirmed.
Outcome measures
| Measure |
IMGN901 60 mg/m2 + Carboplatin AUC 6 + Etoposide 100 mg/m2
n=82 Participants
|
IMGN901 75 mg/m2 + Carboplatin AUC 6 + Etoposide 100 mg/m2
|
IMGN901 75 mg/m2 + Carboplatin AUC 5 + Etoposide 100 mg/m2
|
IMGN901 90 mg/m2 + Carboplatin AUC 5 + Etoposide 100 mg/m2
|
IMGN901 112 mg/m2 + Carboplatin AUC 5 + Etoposide 100 mg/m2
|
|---|---|---|---|---|---|
|
Progression Free Survival (PFS) Rate at 6 Months
|
39 percentage of participants
Interval 28.4 to 50.4
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the time of enrollment until death on study due to any cause (up to post-treatment follow-up 28 days after last dose, up to 22 months)Population: A total of 121 patents were included in the analyses (82 in Arm1 and 39 in Arm 2) due to due to the lack of post-baseline evaluations for 20 participants.
A secondary outcome measure for Phase II was to determine the overall survival of patients treated with IMGN901 in combination with carboplatin/etoposide chemotherapy versus carboplatin/etoposide chemotherapy alone as first-line treatment for patients with extensive stage small cell lung cancer.
Outcome measures
| Measure |
IMGN901 60 mg/m2 + Carboplatin AUC 6 + Etoposide 100 mg/m2
n=82 Participants
|
IMGN901 75 mg/m2 + Carboplatin AUC 6 + Etoposide 100 mg/m2
n=39 Participants
|
IMGN901 75 mg/m2 + Carboplatin AUC 5 + Etoposide 100 mg/m2
|
IMGN901 90 mg/m2 + Carboplatin AUC 5 + Etoposide 100 mg/m2
|
IMGN901 112 mg/m2 + Carboplatin AUC 5 + Etoposide 100 mg/m2
|
|---|---|---|---|---|---|
|
Median Overall Survival (OS) in Phase II
|
10.1 months
Interval 8.7 to 18.1
|
10.97 months
Interval 7.5 to 11.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: A total of 82 patients from the IMGN901 + carboplatin + etoposide safety population (N=94) were included in the efficacy analyses, due to the lack of post-baseline evaluations for 12 participants.
OS was analyzed based on a binary definition of the number of patients dead or censored prior to 12 months and the number of patients alive at 12 months. The primary objective of this phase of the study was to compare PFS in the experimental arm (triplet combination) against historical PFS rates. The control arm was primarily planned to demonstrate whether the or not the historical assumptions regarding efficacy were confirmed. Further, the trial was not empowered to permit a statistically informative comparison of the randomized treatment groups with respect to OS and no determination of the OS rate at 12 months for the control arm was performed; therefore only the results from the experimental arm (IMGN901 + carboplatin + etoposide) are presented.
Outcome measures
| Measure |
IMGN901 60 mg/m2 + Carboplatin AUC 6 + Etoposide 100 mg/m2
n=82 Participants
|
IMGN901 75 mg/m2 + Carboplatin AUC 6 + Etoposide 100 mg/m2
|
IMGN901 75 mg/m2 + Carboplatin AUC 5 + Etoposide 100 mg/m2
|
IMGN901 90 mg/m2 + Carboplatin AUC 5 + Etoposide 100 mg/m2
|
IMGN901 112 mg/m2 + Carboplatin AUC 5 + Etoposide 100 mg/m2
|
|---|---|---|---|---|---|
|
Overall Survival (OS) Rate at 12 Months
|
61 percentage of participants alive
Interval 49.6 to 71.6
|
—
|
—
|
—
|
—
|
Adverse Events
Phase I - IMGN901 + Carboplatin + Etoposide
Serious events: 16 serious events
Other events: 33 other events
Deaths: 0 deaths
Phase II - IMGN901 + Carboplatin + Etoposide
Serious events: 54 serious events
Other events: 91 other events
Deaths: 0 deaths
Phase II - Carboplatin + Etoposide
Serious events: 23 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I - IMGN901 + Carboplatin + Etoposide
n=33 participants at risk
Participants received IMGN901 on Days 1 and 8 of a 21-day cycle. All patients also received carboplatin on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. The starting dose of IMGN901 was 60 mg/m2; dose escalation proceeded, as tolerated, through 75, 90, and 112 mg/m2. Carboplatin was originally dosed at an AUC 6 however due to poor tolerability this was reduced to an AUC of 5. Study drug combinations were administered for four cycles, with up to 6 cycles allowed. IMGN901 was continued as monotherapy for patients who achieved a response or stable disease.
|
Phase II - IMGN901 + Carboplatin + Etoposide
n=94 participants at risk
IMGN901 was administered at the RP2D determined in Phase I (112 mg/m2; later reduced to 90 mg/m2) on Days 1 and 8 of each 21-day cycle. Patients also received carboplatin (AUC 5) on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. Study drug combinations were administered for four cycles, with up to 6 cycles allowed. IMGN901 was continued as monotherapy for patients who achieved a response or stable disease.
|
Phase II - Carboplatin + Etoposide
n=47 participants at risk
Carboplatin (AUC 5) was administered on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. Drugs were administered for 6 cycles as tolerated.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
2.1%
2/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
12.1%
4/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
6.4%
6/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
10.6%
5/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
3.2%
3/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
2.1%
1/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
3.0%
1/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.0%
1/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
1.1%
1/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
4.3%
2/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Cardiac disorders
Atrial defibrillation
|
3.0%
1/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
2.1%
1/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
1.1%
1/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Gastrointestinal disorders
Constipation
|
3.0%
1/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
1.1%
1/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
2.1%
2/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
4.3%
2/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Gastrointestinal disorders
Diverticular perforation
|
3.0%
1/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Gastrointestinal disorders
Pancreatitis
|
3.0%
1/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
2.1%
1/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
General disorders
Non-cardiac chest pain
|
3.0%
1/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
2.1%
2/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
General disorders
Pain
|
3.0%
1/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
2.1%
2/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
General disorders
Pyrexia
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
2.1%
2/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
General disorders
Disease progression
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
1.1%
1/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
2.1%
1/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Infections and infestations
Bacteraemia
|
3.0%
1/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
2.1%
2/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Infections and infestations
Clostridium difficile colitis
|
6.1%
2/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Infections and infestations
Lobar pneumonia
|
3.0%
1/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
2.1%
2/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
4.3%
4/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
2.1%
1/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
6.4%
6/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
4.3%
2/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Infections and infestations
Sepsis
|
6.1%
2/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
2.1%
2/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
2.1%
1/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Infections and infestations
Septic shock
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
3.2%
3/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
1.1%
1/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
2.1%
1/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
1.1%
1/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
3.2%
3/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
2.1%
1/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
3.0%
1/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
3.0%
1/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
2.1%
1/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
1.1%
1/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Nervous system disorders
Convulsion
|
3.0%
1/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
1.1%
1/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Nervous system disorders
Nerve root compression
|
3.0%
1/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
3.2%
3/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Nervous system disorders
Peripheral sensorimotor neuropathy
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
1.1%
1/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
1.1%
1/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Reproductive system and breast disorders
Vulval haemorrhage
|
3.0%
1/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
2.1%
2/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
5.3%
5/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
2.1%
1/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Vascular disorders
Deep vein thrombosis
|
6.1%
2/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Vascular disorders
Hypotension
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
2.1%
2/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Vascular disorders
Hypertension
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
1.1%
1/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
1.1%
1/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Vascular disorders
Arterial thrombosis limb
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
1.1%
1/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
1.1%
1/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
1.1%
1/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Gastrointestinal disorders
Gastrointestinal heamorrhage
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
1.1%
1/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
1.1%
1/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
1.1%
1/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Gastrointestinal disorders
Upper gastrointestinal heamorrhage
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
2.1%
1/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
2.1%
1/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
General disorders
Fatigue
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
1.1%
1/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
1.1%
1/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Infections and infestations
Device related infection
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
1.1%
1/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Infections and infestations
Viral infection
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
1.1%
1/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
1.1%
1/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
1.1%
1/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
2.1%
1/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
2.1%
1/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Investigations
Transaminases increased
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
1.1%
1/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
1.1%
1/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
1.1%
1/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
1.1%
1/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
1.1%
1/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
2.1%
1/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
2.1%
1/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
1.1%
1/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Nervous system disorders
Syncope
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
1.1%
1/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
2.1%
1/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
1.1%
1/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
1.1%
1/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
2.1%
1/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
1.1%
1/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
4.3%
2/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
2.1%
1/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
2.1%
1/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
1.1%
1/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
2.1%
1/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
2.1%
1/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
2.1%
1/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
1.1%
1/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
Other adverse events
| Measure |
Phase I - IMGN901 + Carboplatin + Etoposide
n=33 participants at risk
Participants received IMGN901 on Days 1 and 8 of a 21-day cycle. All patients also received carboplatin on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. The starting dose of IMGN901 was 60 mg/m2; dose escalation proceeded, as tolerated, through 75, 90, and 112 mg/m2. Carboplatin was originally dosed at an AUC 6 however due to poor tolerability this was reduced to an AUC of 5. Study drug combinations were administered for four cycles, with up to 6 cycles allowed. IMGN901 was continued as monotherapy for patients who achieved a response or stable disease.
|
Phase II - IMGN901 + Carboplatin + Etoposide
n=94 participants at risk
IMGN901 was administered at the RP2D determined in Phase I (112 mg/m2; later reduced to 90 mg/m2) on Days 1 and 8 of each 21-day cycle. Patients also received carboplatin (AUC 5) on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. Study drug combinations were administered for four cycles, with up to 6 cycles allowed. IMGN901 was continued as monotherapy for patients who achieved a response or stable disease.
|
Phase II - Carboplatin + Etoposide
n=47 participants at risk
Carboplatin (AUC 5) was administered on Day 1 and etoposide (100 mg/m2) on Days 1, 2, and 3 of each 21-day cycle. Drugs were administered for 6 cycles as tolerated.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
72.7%
24/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
53.2%
50/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
44.7%
21/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
6.1%
2/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Blood and lymphatic system disorders
Leukopenia
|
27.3%
9/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
10.6%
10/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
12.8%
6/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
12.1%
4/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Blood and lymphatic system disorders
Neutropenia
|
30.3%
10/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
56.4%
53/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
51.1%
24/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
6.1%
2/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
48.5%
16/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
34.0%
32/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
40.4%
19/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Gastrointestinal disorders
Abdominal pain
|
24.2%
8/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
5.3%
5/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
6.4%
3/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Gastrointestinal disorders
Constipation
|
36.4%
12/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
31.9%
30/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
19.1%
9/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Gastrointestinal disorders
Diarrhoea
|
27.3%
9/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
31.9%
30/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
17.0%
8/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Gastrointestinal disorders
Dyspepsia
|
18.2%
6/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
13.8%
13/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Gastrointestinal disorders
Dysphagia
|
9.1%
3/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
1.1%
1/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
8.5%
4/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Gastrointestinal disorders
Flatulence
|
6.1%
2/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Gastrointestinal disorders
Nausea
|
39.4%
13/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
42.6%
40/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
36.2%
17/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
11/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
24.5%
23/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
23.4%
11/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
General disorders
Asthenia
|
9.1%
3/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
30.9%
29/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
21.3%
10/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
General disorders
Chills
|
6.1%
2/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
6.4%
6/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
4.3%
2/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
General disorders
Fatigue
|
51.5%
17/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
48.9%
46/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
29.8%
14/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
General disorders
Influenza like illness
|
6.1%
2/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
General disorders
Mucosal inflammation
|
6.1%
2/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
13.8%
13/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
12.8%
6/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
General disorders
Oedema peripheral
|
9.1%
3/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
20.2%
19/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
10.6%
5/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
General disorders
Pain
|
15.2%
5/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
7.4%
7/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
4.3%
2/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
General disorders
Pyrexia
|
24.2%
8/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
10.6%
10/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
10.6%
5/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Infections and infestations
Oral candidiasis
|
9.1%
3/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
5.3%
5/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
4.3%
2/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Infections and infestations
Urinary tract infection
|
15.2%
5/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
10.6%
10/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
14.9%
7/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Injury, poisoning and procedural complications
Fall
|
9.1%
3/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Investigations
Alanine aminotransferase increased
|
6.1%
2/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
11.7%
11/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Investigations
Aspartate aminotransferase increased
|
6.1%
2/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
8.5%
8/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
2.1%
1/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Investigations
Blood alkaline phosphatase increased
|
6.1%
2/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
8.5%
8/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
2.1%
1/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Investigations
Blood creatine increased
|
9.1%
3/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
2.1%
2/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
6.4%
3/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Investigations
Blood pressure increased
|
6.1%
2/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Investigations
Gamma-glutamyltransferase increased
|
9.1%
3/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Investigations
Lipase increased
|
6.1%
2/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
3.2%
3/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
6.4%
3/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Investigations
Lymphocyte count decreased
|
21.2%
7/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Investigations
Neutrophil count decreased
|
21.2%
7/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
11.7%
11/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
14.9%
7/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Investigations
Platelet count decreased
|
6.1%
2/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
17.0%
16/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
12.8%
6/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Investigations
Weight decreased
|
6.1%
2/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
7.4%
7/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
6.4%
3/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Investigations
White blood cell count decreased
|
21.2%
7/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
8.5%
8/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
8.5%
4/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
18.2%
6/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
34.0%
32/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
34.0%
16/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Metabolism and nutrition disorders
Dehydration
|
9.1%
3/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
16.0%
15/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
12.8%
6/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
9.1%
3/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.1%
2/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
5.3%
5/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
4.3%
2/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
9.1%
3/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.1%
2/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
27.3%
9/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
13.8%
13/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
6.4%
3/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
21.2%
7/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
17.0%
16/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
12.8%
6/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
24.2%
8/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
12.8%
12/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
12.8%
6/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Metabolism and nutrition disorders
Hypophospataemia
|
15.2%
5/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
5.3%
5/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
2.1%
1/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
24.2%
8/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
19.1%
18/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
10.6%
5/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.1%
4/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
12.8%
12/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
8.5%
4/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.1%
2/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
5.3%
5/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
6.4%
3/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.1%
2/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.1%
2/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
6.4%
6/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
4.3%
2/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.1%
2/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.1%
2/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
7.4%
7/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
4.3%
2/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.1%
2/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
18.2%
6/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
11.7%
11/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
6.4%
3/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Nervous system disorders
Dizziness
|
9.1%
3/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
13.8%
13/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
10.6%
5/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Nervous system disorders
Dysgeusia
|
12.1%
4/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
10.6%
10/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
12.8%
6/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Nervous system disorders
Headache
|
21.2%
7/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
17.0%
16/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
10.6%
5/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Nervous system disorders
Paraesthesia
|
6.1%
2/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
21.3%
20/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
4.3%
2/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
6.1%
2/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
7.4%
7/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
51.5%
17/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
59.6%
56/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
8.5%
4/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Nervous system disorders
Restless legs syndrome
|
6.1%
2/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Psychiatric disorders
Anxiety
|
6.1%
2/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
8.5%
8/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
2.1%
1/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Psychiatric disorders
Depression
|
6.1%
2/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
5.3%
5/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
2.1%
1/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Psychiatric disorders
Insomnia
|
18.2%
6/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
20.2%
19/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
8.5%
4/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Renal and urinary disorders
Dysuria
|
12.1%
4/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Renal and urinary disorders
Urinary retention
|
6.1%
2/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.2%
6/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
11.7%
11/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
21.3%
10/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
6.1%
2/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
8.5%
8/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
4.3%
2/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.2%
5/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
19.1%
18/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
14.9%
7/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.1%
2/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
5.3%
5/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
4.3%
2/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
15.2%
5/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
6.1%
2/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
30.3%
10/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
34.0%
32/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
34.0%
16/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.1%
2/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.1%
2/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
6.1%
2/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Vascular disorders
Hypertension
|
6.1%
2/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
7.4%
7/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Vascular disorders
Hypotension
|
6.1%
2/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
10.6%
10/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
8.5%
4/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
5.3%
5/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
5.3%
5/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
6.4%
6/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
4.3%
2/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
6.4%
6/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
4.3%
2/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
General disorders
Malaise
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
6.4%
6/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
7.4%
7/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
12.8%
6/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
6.4%
6/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
4.3%
2/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Investigations
Blood amylase increased
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
7.4%
7/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
4.3%
2/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
12.8%
12/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
6.4%
3/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Nervous system disorders
Hyporeflexia
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
6.4%
3/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
8.5%
8/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
2.1%
1/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Vascular disorders
Hot flush
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
5.3%
5/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
6.4%
6/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
2.1%
1/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
0.00%
0/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
6.4%
3/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
5.3%
5/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
2.1%
1/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
2.1%
2/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
8.5%
4/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/33 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
6.4%
6/94 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
2.1%
1/47 • Reported SAEs include events from the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment.
AEs and laboratory results were graded using the NCI CTCAE, version 4.0.
|
Additional Information
Dr. Richard Bates, Sr. Manager, Publications
ImmunoGen Inc.
Phone: 781 895 0196
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60