Trial Outcomes & Findings for Avelumab, Utomilumab, Anti-OX40 Antibody PF-04518600, and Radiation Therapy in Treating Patients With Advanced Malignancies (NCT NCT03217747)
NCT ID: NCT03217747
Last Updated: 2025-10-23
Results Overview
DLTs were adverse events (AEs) related to study drug in the first 2 cycles and fulfilled one of the following * Discontinuation due to drug and/or XRT-related toxicity before DLT period ends * Delay \>28 days in receiving the next cycle due to drug and/or XRT-related toxicity * Hematologic * Gr4 neutropenia ≥7 days * Febrile neutropenia * Gr ≥3 thrombocytopenia associated with bleeding, or Gr 4 thrombocytopenia * Gr 4 anemia * Non-hematologic * Gr ≥3 nausea/vomiting or diarrhea ≥72 hours despite optimal supportive medications * Gr ≥3 fatigue ≥7 days * Gr≥2 pneumonitis ≥7 days despite corticosteroids * Gr≥3 rash ≥7 days despite treatment * Gr≥3 immune related toxicities ≥7 days despite corticosteroids * Any other Gr≥3 non-hematological toxicity (except for asymptomatic electrolytes abnormalities or hair loss which is not dose-limiting) * Gr≥3 AST, ALT, or total bilirubin elevation ≥7 days. Delay of treatment \> 14 days due to non-hematologic toxicity
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1/PHASE2
Target enrollment
173 participants
Primary outcome timeframe
DLT was assessed during the first 2 cycles or 8 weeks (56 days) since C1D1 of treatment.
Results posted on
2025-10-23
Participant Flow
This is an open label, single center Phase I/II combination study to evaluate safety, pharmacodynamics, and anti-tumor activity of avelumab in combination with other cancer immunotherapies in Pfizer pipeline with or without radiation (XRT), in patients within metastatic cancers at The University of Texas MD Anderson Cancer Center.
Of the 173 patients enrolled, only 111 patients received at least 1 dose of the study agents. The remaining 62 patients screen failed and did not receive any dose of the study drugs. Per the protocol, all 111 patients who received one or more doses of drug were included in the analysis and the results are reported here.
Participant milestones
| Measure |
Arm A Exp Avelumab Starting From C1D15
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 100 mg IV every 4 weeks
|
Arm A Exp Avelumab Starting From C3D1
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 100 mg IV every 4 weeks
|
Arm B Exp Avelumab Starting From C1D15
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Ivuxolimab: Given IV
Utomilumab: Given IV
|
Arm B Exp Avelumab Starting From C3D1
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks
Utomilumab: Given IV
|
Arm C Escalation Avelumab Starting From C1D1
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks
Ivuxolimab: Given IV
Radiation Therapy: Undergo radiation therapy
|
Arm C Exp Avelumab Starting From C1D15
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks
Avelumab: Given IV
Ivuxolimab: Given IV
Radiation Therapy: Undergo radiation therapy
Utomilumab: Given IV
|
Arm C Exp Avelumab Starting From C3D1
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks
|
Arm D Esc Schedule-1 Dose Level 1; XRT: Starting C1D2 to C1D11
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm D Esc Schedule-2 Dose Level 1; XRT: Starting Days -14 to -1
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm D Esc Schedule-3 Dose Level 1; XRT: Starting C1D1 to C1D3
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm E Esc Schedule-1 Dose Level 1; XRT: Starting C1D2 to C1D11
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks XRT: 60 Gy for 10 fractions
|
Arm E Esc Schedule-2 Dose Level 1; XRT: Starting Days -14 to -1
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks XRT: 60 Gy for 10 fractions
|
Arm F Esc Schedule-1 Dose Level 1; Avelumab Starting From C1D1, XRT: Starting C1D2 to C1D11
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm F Esc Schedule-2 Dose Level 1; Avelumab Starting From C1D15, XRT: Starting Days -14 to -1
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
8
|
16
|
12
|
4
|
17
|
11
|
4
|
3
|
7
|
3
|
3
|
4
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
16
|
8
|
16
|
12
|
4
|
17
|
11
|
4
|
3
|
7
|
3
|
3
|
4
|
3
|
Reasons for withdrawal
| Measure |
Arm A Exp Avelumab Starting From C1D15
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 100 mg IV every 4 weeks
|
Arm A Exp Avelumab Starting From C3D1
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 100 mg IV every 4 weeks
|
Arm B Exp Avelumab Starting From C1D15
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Ivuxolimab: Given IV
Utomilumab: Given IV
|
Arm B Exp Avelumab Starting From C3D1
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks
Utomilumab: Given IV
|
Arm C Escalation Avelumab Starting From C1D1
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks
Ivuxolimab: Given IV
Radiation Therapy: Undergo radiation therapy
|
Arm C Exp Avelumab Starting From C1D15
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks
Avelumab: Given IV
Ivuxolimab: Given IV
Radiation Therapy: Undergo radiation therapy
Utomilumab: Given IV
|
Arm C Exp Avelumab Starting From C3D1
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks
|
Arm D Esc Schedule-1 Dose Level 1; XRT: Starting C1D2 to C1D11
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm D Esc Schedule-2 Dose Level 1; XRT: Starting Days -14 to -1
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm D Esc Schedule-3 Dose Level 1; XRT: Starting C1D1 to C1D3
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm E Esc Schedule-1 Dose Level 1; XRT: Starting C1D2 to C1D11
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks XRT: 60 Gy for 10 fractions
|
Arm E Esc Schedule-2 Dose Level 1; XRT: Starting Days -14 to -1
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks XRT: 60 Gy for 10 fractions
|
Arm F Esc Schedule-1 Dose Level 1; Avelumab Starting From C1D1, XRT: Starting C1D2 to C1D11
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm F Esc Schedule-2 Dose Level 1; Avelumab Starting From C1D15, XRT: Starting Days -14 to -1
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
12
|
6
|
15
|
11
|
3
|
14
|
10
|
4
|
2
|
7
|
3
|
1
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
1
|
1
|
1
|
2
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
Toxicity and progression
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Removal of sole target lesion
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Stroke
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Avelumab, Utomilumab, Anti-OX40 Antibody PF-04518600, and Radiation Therapy in Treating Patients With Advanced Malignancies
Baseline characteristics by cohort
| Measure |
Arm A Exp Avelumab Starting From C1D15
n=16 Participants
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 100 mg IV every 4 weeks
|
Arm A Exp Avelumab Starting From C3D1
n=8 Participants
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 100 mg IV every 4 weeks
|
Arm B Exp Avelumab Starting From C1D15
n=16 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Ivuxolimab: Given IV
Utomilumab: Given IV
|
Arm B Exp Avelumab Starting From C3D1
n=12 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks
Utomilumab: Given IV
|
Arm C Escalation Avelumab Starting From C1D1
n=4 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks
Ivuxolimab: Given IV
Radiation Therapy: Undergo radiation therapy
|
Arm C Exp Avelumab Starting From C1D15
n=17 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks
Avelumab: Given IV
Ivuxolimab: Given IV
Radiation Therapy: Undergo radiation therapy
Utomilumab: Given IV
|
Arm C Exp Avelumab Starting From C3D1
n=11 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks
|
Arm D Esc Schedule-1 Dose Level 1; XRT: Starting C1D2 to C1D11
n=4 Participants
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm D Esc Schedule-2 Dose Level 1; XRT: Starting Days -14 to -1
n=3 Participants
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm D Esc Schedule-3 Dose Level 1; XRT: Starting C1D1 to C1D3
n=7 Participants
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm E Esc Schedule-1 Dose Level 1; XRT: Starting C1D2 to C1D11
n=3 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks XRT: 60 Gy for 10 fractions
|
Arm E Esc Schedule-2 Dose Level 1; XRT: Starting Days -14 to -1
n=3 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks XRT: 60 Gy for 10 fractions
|
Arm F Esc Schedule-1 Dose Level 1; Avelumab Starting From C1D1, XRT: Starting C1D2 to C1D11
n=4 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm F Esc Schedule-2 Dose Level 1; Avelumab Starting From C1D15, XRT: Starting Days -14 to -1
n=3 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Total
n=111 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
81 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
30 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
72 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
39 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
12 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
4 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
98 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
7 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
10 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
87 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
6 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
12 participants
n=4 Participants
|
4 participants
n=21 Participants
|
17 participants
n=8 Participants
|
11 participants
n=8 Participants
|
4 participants
n=24 Participants
|
3 participants
n=42 Participants
|
7 participants
n=42 Participants
|
3 participants
n=42 Participants
|
3 participants
n=42 Participants
|
4 participants
n=36 Participants
|
3 participants
n=36 Participants
|
111 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: DLT was assessed during the first 2 cycles or 8 weeks (56 days) since C1D1 of treatment.Population: All enrolled patients who received at least one dose of each study medication in the assigned treatment combination were evaluable for DLT. Patients who missed any doses during the DLT period for reasons unrelated to study drug and patients who are lost to follow-up due to reasons unrelated to treatment related AEs are not evaluable for DLT
DLTs were adverse events (AEs) related to study drug in the first 2 cycles and fulfilled one of the following * Discontinuation due to drug and/or XRT-related toxicity before DLT period ends * Delay \>28 days in receiving the next cycle due to drug and/or XRT-related toxicity * Hematologic * Gr4 neutropenia ≥7 days * Febrile neutropenia * Gr ≥3 thrombocytopenia associated with bleeding, or Gr 4 thrombocytopenia * Gr 4 anemia * Non-hematologic * Gr ≥3 nausea/vomiting or diarrhea ≥72 hours despite optimal supportive medications * Gr ≥3 fatigue ≥7 days * Gr≥2 pneumonitis ≥7 days despite corticosteroids * Gr≥3 rash ≥7 days despite treatment * Gr≥3 immune related toxicities ≥7 days despite corticosteroids * Any other Gr≥3 non-hematological toxicity (except for asymptomatic electrolytes abnormalities or hair loss which is not dose-limiting) * Gr≥3 AST, ALT, or total bilirubin elevation ≥7 days. Delay of treatment \> 14 days due to non-hematologic toxicity
Outcome measures
| Measure |
Arm A Exp Avelumab Starting From C1D15
n=16 Participants
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 100 mg IV every 4 weeks
|
Arm A Exp Avelumab Starting From C3D1
n=8 Participants
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 100 mg IV every 4 weeks
|
Arm B Exp Avelumab Starting From C1D15
n=16 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Ivuxolimab: Given IV
Utomilumab: Given IV
|
Arm B Exp Avelumab Starting From C3D1
n=12 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks
Utomilumab: Given IV
|
Arm C Escalation Avelumab Starting From C1D1
n=4 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks
Ivuxolimab: Given IV
Radiation Therapy: Undergo radiation therapy
|
Arm C Exp Avelumab Starting From C1D15
n=17 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks
Avelumab: Given IV
Ivuxolimab: Given IV
Radiation Therapy: Undergo radiation therapy
Utomilumab: Given IV
|
Arm C Exp Avelumab Starting From C3D1
n=11 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks
|
Arm D Esc Schedule-1 Dose Level 1; XRT: Starting C1D2 to C1D11
n=4 Participants
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm D Esc Schedule-2 Dose Level 1; XRT: Starting Days -14 to -1
n=3 Participants
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm D Esc Schedule-3 Dose Level 1; XRT: Starting C1D1 to C1D3
n=7 Participants
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm E Esc Schedule-1 Dose Level 1; XRT: Starting C1D2 to C1D11
n=3 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks XRT: 60 Gy for 10 fractions
|
Arm E Esc Schedule-2 Dose Level 1; XRT: Starting Days -14 to -1
n=3 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks XRT: 60 Gy for 10 fractions
|
Arm F Esc Schedule-1 Dose Level 1; Avelumab Starting From C1D1, XRT: Starting C1D2 to C1D11
n=4 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm F Esc Schedule-2 Dose Level 1; Avelumab Starting From C1D15, XRT: Starting Days -14 to -1
n=3 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose-limiting Toxicities (DLTs) (All Will be Graded According to CTCAEv4.03 Criteria)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At baseline and at 8-week intervals (± 7 days). Confirmatory scans were obtained 4-8 weeks following initial objective response. After 1 year of treatment scans at 12-week intervals (± 7 days), independent of cycle delays, assessed upto 3 years.Population: All enrolled patients who were eligible, had received at least one cycle of therapy, and had baseline assessments and at least 1 on-study tumor assessment were considered evaluable for response. Patients who were treated and removed from study prior to on-study tumor assessment because of disease progression were also considered evaluable. In XRT arms, patients were considered evaluable on the study if patients received 75% of radiation dose
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) using CT, MRI,or PET-CT scan: Complete Response (CR),Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.
Outcome measures
| Measure |
Arm A Exp Avelumab Starting From C1D15
n=13 Participants
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 100 mg IV every 4 weeks
|
Arm A Exp Avelumab Starting From C3D1
n=8 Participants
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 100 mg IV every 4 weeks
|
Arm B Exp Avelumab Starting From C1D15
n=14 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Ivuxolimab: Given IV
Utomilumab: Given IV
|
Arm B Exp Avelumab Starting From C3D1
n=10 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks
Utomilumab: Given IV
|
Arm C Escalation Avelumab Starting From C1D1
n=3 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks
Ivuxolimab: Given IV
Radiation Therapy: Undergo radiation therapy
|
Arm C Exp Avelumab Starting From C1D15
n=14 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks
Avelumab: Given IV
Ivuxolimab: Given IV
Radiation Therapy: Undergo radiation therapy
Utomilumab: Given IV
|
Arm C Exp Avelumab Starting From C3D1
n=9 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks
|
Arm D Esc Schedule-1 Dose Level 1; XRT: Starting C1D2 to C1D11
n=4 Participants
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm D Esc Schedule-2 Dose Level 1; XRT: Starting Days -14 to -1
n=1 Participants
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm D Esc Schedule-3 Dose Level 1; XRT: Starting C1D1 to C1D3
n=7 Participants
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm E Esc Schedule-1 Dose Level 1; XRT: Starting C1D2 to C1D11
n=3 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks XRT: 60 Gy for 10 fractions
|
Arm E Esc Schedule-2 Dose Level 1; XRT: Starting Days -14 to -1
n=2 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks XRT: 60 Gy for 10 fractions
|
Arm F Esc Schedule-1 Dose Level 1; Avelumab Starting From C1D1, XRT: Starting C1D2 to C1D11
n=4 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm F Esc Schedule-2 Dose Level 1; Avelumab Starting From C1D15, XRT: Starting Days -14 to -1
n=1 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate Per RECIST v1.1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At baseline and at 8-week intervals (± 7 days). Confirmatory scans were obtained 4-8 weeks following initial objective response. After 1 year of treatment scans at 12-week intervals (± 7 days), independent of cycle delays, assessed upto 3 years.Population: All enrolled patients who were eligible, had received at least one cycle of therapy, and had baseline assessments and at least 1 on-study tumor assessment were considered evaluable for response. Patients who were treated and removed from study prior to on-study tumor assessment because of disease progression were also considered evaluable. In XRT arms, patients were considered evaluable on the study if patients received 75% of radiation dose
Per Immune-related Response Evaluation Criteria In Solid Tumors Criteria (irRECIST) using CT, MRI,or PET-CT scan: Immune-related Complete Response (irCR),Disappearance of all target lesions; Immune-related Partial Response (irPR), \>=30% decrease in the sum of the longest diameter of target and new lesions; OR = irCR + irPR.
Outcome measures
| Measure |
Arm A Exp Avelumab Starting From C1D15
n=13 Participants
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 100 mg IV every 4 weeks
|
Arm A Exp Avelumab Starting From C3D1
n=8 Participants
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 100 mg IV every 4 weeks
|
Arm B Exp Avelumab Starting From C1D15
n=14 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Ivuxolimab: Given IV
Utomilumab: Given IV
|
Arm B Exp Avelumab Starting From C3D1
n=10 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks
Utomilumab: Given IV
|
Arm C Escalation Avelumab Starting From C1D1
n=3 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks
Ivuxolimab: Given IV
Radiation Therapy: Undergo radiation therapy
|
Arm C Exp Avelumab Starting From C1D15
n=14 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks
Avelumab: Given IV
Ivuxolimab: Given IV
Radiation Therapy: Undergo radiation therapy
Utomilumab: Given IV
|
Arm C Exp Avelumab Starting From C3D1
n=9 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks
|
Arm D Esc Schedule-1 Dose Level 1; XRT: Starting C1D2 to C1D11
n=4 Participants
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm D Esc Schedule-2 Dose Level 1; XRT: Starting Days -14 to -1
n=1 Participants
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm D Esc Schedule-3 Dose Level 1; XRT: Starting C1D1 to C1D3
n=7 Participants
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm E Esc Schedule-1 Dose Level 1; XRT: Starting C1D2 to C1D11
n=3 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks XRT: 60 Gy for 10 fractions
|
Arm E Esc Schedule-2 Dose Level 1; XRT: Starting Days -14 to -1
n=2 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks XRT: 60 Gy for 10 fractions
|
Arm F Esc Schedule-1 Dose Level 1; Avelumab Starting From C1D1, XRT: Starting C1D2 to C1D11
n=4 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm F Esc Schedule-2 Dose Level 1; Avelumab Starting From C1D15, XRT: Starting Days -14 to -1
n=1 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate Per irRECIST
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At baseline and at 8-week intervals (± 7 days). Confirmatory scans were obtained 4-8 weeks following initial objective response. After 1 year of treatment scans at 12-week intervals (± 7 days), independent of cycle delays, assessed upto 3 years.Population: All enrolled patients who were eligible, had received at least one cycle of therapy, and had baseline assessments and at least 1 on-study tumor assessment were considered evaluable for response. Patients who were treated and removed from study prior to on-study tumor assessment because of disease progression were also considered evaluable. In XRT arms, patients were considered evaluable on the study if patients received 75% of radiation dose
Per RECIST v1.0 using CT, MRI,or PET-CT scan: CR,Disappearance of all target lesions; PR, \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), Increase ≥20% of the sum of longest diameter compared with nadir (minimum 5 mm) or progression of non-target lesions or new lesion; Stable Disease (SD), Neither PR nor PD; Clinical benefit (CB) = CR + PR + SD ≥6 months.
Outcome measures
| Measure |
Arm A Exp Avelumab Starting From C1D15
n=13 Participants
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 100 mg IV every 4 weeks
|
Arm A Exp Avelumab Starting From C3D1
n=8 Participants
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 100 mg IV every 4 weeks
|
Arm B Exp Avelumab Starting From C1D15
n=14 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Ivuxolimab: Given IV
Utomilumab: Given IV
|
Arm B Exp Avelumab Starting From C3D1
n=10 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks
Utomilumab: Given IV
|
Arm C Escalation Avelumab Starting From C1D1
n=3 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks
Ivuxolimab: Given IV
Radiation Therapy: Undergo radiation therapy
|
Arm C Exp Avelumab Starting From C1D15
n=14 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks
Avelumab: Given IV
Ivuxolimab: Given IV
Radiation Therapy: Undergo radiation therapy
Utomilumab: Given IV
|
Arm C Exp Avelumab Starting From C3D1
n=9 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks
|
Arm D Esc Schedule-1 Dose Level 1; XRT: Starting C1D2 to C1D11
n=4 Participants
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm D Esc Schedule-2 Dose Level 1; XRT: Starting Days -14 to -1
n=1 Participants
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm D Esc Schedule-3 Dose Level 1; XRT: Starting C1D1 to C1D3
n=7 Participants
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm E Esc Schedule-1 Dose Level 1; XRT: Starting C1D2 to C1D11
n=3 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks XRT: 60 Gy for 10 fractions
|
Arm E Esc Schedule-2 Dose Level 1; XRT: Starting Days -14 to -1
n=2 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks XRT: 60 Gy for 10 fractions
|
Arm F Esc Schedule-1 Dose Level 1; Avelumab Starting From C1D1, XRT: Starting C1D2 to C1D11
n=4 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm F Esc Schedule-2 Dose Level 1; Avelumab Starting From C1D15, XRT: Starting Days -14 to -1
n=1 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Clinical Benefit Rate Per RECIST v1.1
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At baseline and at 8-week intervals (± 7 days). Confirmatory scans were obtained 4-8 weeks following initial objective response. After 1 year of treatment scans at 12-week intervals (± 7 days), independent of cycle delays, assessed upto 3 years.Population: All enrolled patients who were eligible, had received at least one cycle of therapy, and had baseline assessments and at least 1 on-study tumor assessment were considered evaluable for response. Patients who were treated and removed from study prior to on-study tumor assessment because of disease progression were also considered evaluable . In XRT arms, patients were considered evaluable on the study if patients received 75% of radiation dose
Per irRECIST using CT, MRI,or PET-CT scan: irCR,Disappearance of all target lesions; irPR, \>=30% decrease in the sum of the longest diameter of target and new lesions; Immune-related Progressive Disease (irPD), Increase ≥20% of the sum of longest diameter of target and new lesion compared with nadir (minimum 5 mm) or progression of non-target lesions ; Immune-related Stable Disease (irSD), Neither irPR nor irPD; Clinical benefit (CB) = irCR + irPR + irSD ≥6 months.
Outcome measures
| Measure |
Arm A Exp Avelumab Starting From C1D15
n=13 Participants
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 100 mg IV every 4 weeks
|
Arm A Exp Avelumab Starting From C3D1
n=8 Participants
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 100 mg IV every 4 weeks
|
Arm B Exp Avelumab Starting From C1D15
n=14 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Ivuxolimab: Given IV
Utomilumab: Given IV
|
Arm B Exp Avelumab Starting From C3D1
n=10 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks
Utomilumab: Given IV
|
Arm C Escalation Avelumab Starting From C1D1
n=3 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks
Ivuxolimab: Given IV
Radiation Therapy: Undergo radiation therapy
|
Arm C Exp Avelumab Starting From C1D15
n=14 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks
Avelumab: Given IV
Ivuxolimab: Given IV
Radiation Therapy: Undergo radiation therapy
Utomilumab: Given IV
|
Arm C Exp Avelumab Starting From C3D1
n=9 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks
|
Arm D Esc Schedule-1 Dose Level 1; XRT: Starting C1D2 to C1D11
n=4 Participants
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm D Esc Schedule-2 Dose Level 1; XRT: Starting Days -14 to -1
n=1 Participants
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm D Esc Schedule-3 Dose Level 1; XRT: Starting C1D1 to C1D3
n=7 Participants
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm E Esc Schedule-1 Dose Level 1; XRT: Starting C1D2 to C1D11
n=3 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks XRT: 60 Gy for 10 fractions
|
Arm E Esc Schedule-2 Dose Level 1; XRT: Starting Days -14 to -1
n=2 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks XRT: 60 Gy for 10 fractions
|
Arm F Esc Schedule-1 Dose Level 1; Avelumab Starting From C1D1, XRT: Starting C1D2 to C1D11
n=4 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm F Esc Schedule-2 Dose Level 1; Avelumab Starting From C1D15, XRT: Starting Days -14 to -1
n=1 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Clinical Benefit Rate Per irRECIST
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At baseline and at 8-week intervals (± 7 days). Confirmatory scans were obtained 4-8 weeks following initial objective response. After 1 year of treatment scans at 12-week intervals (± 7 days), independent of cycle delays, assessed upto 3 years.Population: All enrolled patients who were eligible, had received at least one cycle of therapy, and had baseline assessments and at least 1 on-study tumor assessment were considered evaluable for response. Patients who were treated and removed from study prior to on-study tumor assessment because of disease progression were also considered evaluable . In XRT arms, patients were considered evaluable on the study if patients received 75% of radiation dose
Per RECIST v1.0 using CT, MRI,or PET-CT scan: CR,Disappearance of all target lesions; PR, \>=30% decrease in the sum of the longest diameter of target lesions; PD, Increase ≥20% of the sum of longest diameter compared with nadir (minimum 5 mm) or progression of non-target lesions or new lesion; SD, Neither PR nor PD; Disease control (DC) = CR + PR + SD.
Outcome measures
| Measure |
Arm A Exp Avelumab Starting From C1D15
n=13 Participants
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 100 mg IV every 4 weeks
|
Arm A Exp Avelumab Starting From C3D1
n=8 Participants
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 100 mg IV every 4 weeks
|
Arm B Exp Avelumab Starting From C1D15
n=14 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Ivuxolimab: Given IV
Utomilumab: Given IV
|
Arm B Exp Avelumab Starting From C3D1
n=10 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks
Utomilumab: Given IV
|
Arm C Escalation Avelumab Starting From C1D1
n=3 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks
Ivuxolimab: Given IV
Radiation Therapy: Undergo radiation therapy
|
Arm C Exp Avelumab Starting From C1D15
n=14 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks
Avelumab: Given IV
Ivuxolimab: Given IV
Radiation Therapy: Undergo radiation therapy
Utomilumab: Given IV
|
Arm C Exp Avelumab Starting From C3D1
n=9 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks
|
Arm D Esc Schedule-1 Dose Level 1; XRT: Starting C1D2 to C1D11
n=4 Participants
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm D Esc Schedule-2 Dose Level 1; XRT: Starting Days -14 to -1
n=1 Participants
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm D Esc Schedule-3 Dose Level 1; XRT: Starting C1D1 to C1D3
n=7 Participants
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm E Esc Schedule-1 Dose Level 1; XRT: Starting C1D2 to C1D11
n=3 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks XRT: 60 Gy for 10 fractions
|
Arm E Esc Schedule-2 Dose Level 1; XRT: Starting Days -14 to -1
n=2 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks XRT: 60 Gy for 10 fractions
|
Arm F Esc Schedule-1 Dose Level 1; Avelumab Starting From C1D1, XRT: Starting C1D2 to C1D11
n=4 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm F Esc Schedule-2 Dose Level 1; Avelumab Starting From C1D15, XRT: Starting Days -14 to -1
n=1 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Disease Control Rate Per RECIST v1.1
|
4 Participants
|
7 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At baseline and at 8-week intervals (± 7 days). Confirmatory scans were obtained 4-8 weeks following initial objective response. After 1 year of treatment scans at 12-week intervals (± 7 days), independent of cycle delays, assessed upto 3 years.Population: All enrolled patients who were eligible, had received at least one cycle of therapy, and had baseline assessments and at least 1 on-study tumor assessment were considered evaluable for response. Patients who were treated and removed from study prior to on-study tumor assessment because of disease progression were also considered evaluable. In XRT arms, patients were considered evaluable on the study if patients received 75% of radiation dose
Per irRECIST using CT, MRI,or PET-CT scan: irCR,Disappearance of all target lesions; irPR, \>=30% decrease in the sum of the longest diameter of target and new lesions; irPD, Increase ≥20% of the sum of longest diameter of target and new lesion compared with nadir (minimum 5 mm) or progression of non-target lesions ; irSD, Neither irPR nor irPD; Disease control (DC) = irCR + irPR + irSD.
Outcome measures
| Measure |
Arm A Exp Avelumab Starting From C1D15
n=13 Participants
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 100 mg IV every 4 weeks
|
Arm A Exp Avelumab Starting From C3D1
n=8 Participants
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 100 mg IV every 4 weeks
|
Arm B Exp Avelumab Starting From C1D15
n=14 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Ivuxolimab: Given IV
Utomilumab: Given IV
|
Arm B Exp Avelumab Starting From C3D1
n=10 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks
Utomilumab: Given IV
|
Arm C Escalation Avelumab Starting From C1D1
n=3 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks
Ivuxolimab: Given IV
Radiation Therapy: Undergo radiation therapy
|
Arm C Exp Avelumab Starting From C1D15
n=14 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks
Avelumab: Given IV
Ivuxolimab: Given IV
Radiation Therapy: Undergo radiation therapy
Utomilumab: Given IV
|
Arm C Exp Avelumab Starting From C3D1
n=9 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks
|
Arm D Esc Schedule-1 Dose Level 1; XRT: Starting C1D2 to C1D11
n=4 Participants
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm D Esc Schedule-2 Dose Level 1; XRT: Starting Days -14 to -1
n=1 Participants
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm D Esc Schedule-3 Dose Level 1; XRT: Starting C1D1 to C1D3
n=7 Participants
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm E Esc Schedule-1 Dose Level 1; XRT: Starting C1D2 to C1D11
n=3 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks XRT: 60 Gy for 10 fractions
|
Arm E Esc Schedule-2 Dose Level 1; XRT: Starting Days -14 to -1
n=2 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks XRT: 60 Gy for 10 fractions
|
Arm F Esc Schedule-1 Dose Level 1; Avelumab Starting From C1D1, XRT: Starting C1D2 to C1D11
n=4 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm F Esc Schedule-2 Dose Level 1; Avelumab Starting From C1D15, XRT: Starting Days -14 to -1
n=1 Participants
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Disease Control Rate Per irRECIST
|
7 Participants
|
6 Participants
|
5 Participants
|
5 Participants
|
1 Participants
|
5 Participants
|
5 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
Adverse Events
Arm A Exp Avelumab Starting From C1D15
Serious events: 8 serious events
Other events: 15 other events
Deaths: 15 deaths
Arm A Exp Avelumab Starting From C3D1
Serious events: 6 serious events
Other events: 8 other events
Deaths: 6 deaths
Arm B Exp Avelumab Starting From C1D15
Serious events: 3 serious events
Other events: 14 other events
Deaths: 13 deaths
Arm B Exp Avelumab Starting From C3D1
Serious events: 7 serious events
Other events: 11 other events
Deaths: 10 deaths
Arm C Escalation Avelumab Starting From C1D1
Serious events: 3 serious events
Other events: 4 other events
Deaths: 3 deaths
Arm C Exp Avelumab Starting From C1D15
Serious events: 6 serious events
Other events: 15 other events
Deaths: 15 deaths
Arm C Exp Avelumab Starting From C3D1
Serious events: 5 serious events
Other events: 11 other events
Deaths: 9 deaths
Arm D Esc Schedule-1 Dose Level 1; XRT: Starting C1D2 to C1D11
Serious events: 4 serious events
Other events: 4 other events
Deaths: 4 deaths
Arm D Esc Schedule-2 Dose Level 1; XRT: Starting Days -14 to -1
Serious events: 3 serious events
Other events: 2 other events
Deaths: 3 deaths
Arm D Esc Schedule-3 Dose Level 1; XRT: Starting C1D1 to C1D3
Serious events: 0 serious events
Other events: 7 other events
Deaths: 7 deaths
Arm E Esc Schedule-1 Dose Level 1; XRT: Starting C1D2 to C1D11
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
Arm E Esc Schedule-2 Dose Level 1; XRT: Starting Days -14 to -1
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
Arm F Esc Schedule-1 Dose Level 1; Avelumab Starting From C1D1, XRT: Starting C1D2 to C1D11
Serious events: 4 serious events
Other events: 4 other events
Deaths: 4 deaths
Arm F Esc Schedule-2 Dose Level 1; Avelumab Starting From C1D15, XRT: Starting Days -14 to -1
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Arm A Exp Avelumab Starting From C1D15
n=16 participants at risk
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 100 mg IV every 4 weeks
|
Arm A Exp Avelumab Starting From C3D1
n=8 participants at risk
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 100 mg IV every 4 weeks
|
Arm B Exp Avelumab Starting From C1D15
n=16 participants at risk
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Ivuxolimab: Given IV
Utomilumab: Given IV
|
Arm B Exp Avelumab Starting From C3D1
n=12 participants at risk
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks
Utomilumab: Given IV
|
Arm C Escalation Avelumab Starting From C1D1
n=4 participants at risk
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks
Ivuxolimab: Given IV
Radiation Therapy: Undergo radiation therapy
|
Arm C Exp Avelumab Starting From C1D15
n=17 participants at risk
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks
Avelumab: Given IV
Ivuxolimab: Given IV
Radiation Therapy: Undergo radiation therapy
Utomilumab: Given IV
|
Arm C Exp Avelumab Starting From C3D1
n=11 participants at risk
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks
|
Arm D Esc Schedule-1 Dose Level 1; XRT: Starting C1D2 to C1D11
n=4 participants at risk
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm D Esc Schedule-2 Dose Level 1; XRT: Starting Days -14 to -1
n=3 participants at risk
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm D Esc Schedule-3 Dose Level 1; XRT: Starting C1D1 to C1D3
n=7 participants at risk
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm E Esc Schedule-1 Dose Level 1; XRT: Starting C1D2 to C1D11
n=3 participants at risk
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks XRT: 60 Gy for 10 fractions
|
Arm E Esc Schedule-2 Dose Level 1; XRT: Starting Days -14 to -1
n=3 participants at risk
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks XRT: 60 Gy for 10 fractions
|
Arm F Esc Schedule-1 Dose Level 1; Avelumab Starting From C1D1, XRT: Starting C1D2 to C1D11
n=4 participants at risk
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm F Esc Schedule-2 Dose Level 1; Avelumab Starting From C1D15, XRT: Starting Days -14 to -1
n=3 participants at risk
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
8.3%
1/12 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Injury, poisoning and procedural complications
Prolapse of intestinal stoma
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Infections and infestations
Sepsis
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Investigations
Serum amylase increased
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Infections and infestations
Skin infection
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
3/12 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Nervous system disorders
Stroke
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
5.9%
1/17 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
8.3%
1/12 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Injury, poisoning and procedural complications
Tracheostomy site bleeding
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
8.3%
1/12 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
8.3%
1/12 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
11.8%
2/17 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
9.1%
1/11 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Renal and urinary disorders
Acute kidney injury
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
50.0%
2/4 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
5.9%
1/17 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
5.9%
1/17 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Gastrointestinal disorders
Ascites
|
12.5%
2/16 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
5.9%
1/17 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
5.9%
1/17 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Immune system disorders
Autoimmune disorder, hepatitis
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
5.9%
1/17 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
5.9%
1/17 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
50.0%
2/4 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Psychiatric disorders
Confusion
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
5.9%
1/17 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
9.1%
1/11 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
General disorders
Death NOS
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Infections and infestations
Device related infection
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
8.3%
1/12 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
9.1%
1/11 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
50.0%
2/4 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
9.1%
1/11 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
General disorders
Edema limbs
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Infections and infestations
Encephalomyelitis infection
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Infections and infestations
Endocarditis infective
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Gastrointestinal disorders
Esophageal hemorrhage
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
General disorders
Fatigue
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
16.7%
2/12 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
9.1%
1/11 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
General disorders
Fever
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
8.3%
1/12 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Gastric outlet obstruction
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
5.9%
1/17 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Hepatobiliary disorders
Hepatic Failure
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
66.7%
2/3 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Infections and infestations
Infections and infestations - Other, specify
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
8.3%
1/12 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Investigations
Lipase increased
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
8.3%
1/12 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Infections and infestations
Lung infection
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
12.5%
2/16 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
8.3%
1/12 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
5.9%
1/17 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Infections and infestations
Peritoneal infection
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Investigations
Platelet count decreased
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
Other adverse events
| Measure |
Arm A Exp Avelumab Starting From C1D15
n=16 participants at risk
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 100 mg IV every 4 weeks
|
Arm A Exp Avelumab Starting From C3D1
n=8 participants at risk
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 100 mg IV every 4 weeks
|
Arm B Exp Avelumab Starting From C1D15
n=16 participants at risk
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Ivuxolimab: Given IV
Utomilumab: Given IV
|
Arm B Exp Avelumab Starting From C3D1
n=12 participants at risk
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks
Utomilumab: Given IV
|
Arm C Escalation Avelumab Starting From C1D1
n=4 participants at risk
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks
Ivuxolimab: Given IV
Radiation Therapy: Undergo radiation therapy
|
Arm C Exp Avelumab Starting From C1D15
n=17 participants at risk
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks
Avelumab: Given IV
Ivuxolimab: Given IV
Radiation Therapy: Undergo radiation therapy
Utomilumab: Given IV
|
Arm C Exp Avelumab Starting From C3D1
n=11 participants at risk
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks
|
Arm D Esc Schedule-1 Dose Level 1; XRT: Starting C1D2 to C1D11
n=4 participants at risk
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm D Esc Schedule-2 Dose Level 1; XRT: Starting Days -14 to -1
n=3 participants at risk
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm D Esc Schedule-3 Dose Level 1; XRT: Starting C1D1 to C1D3
n=7 participants at risk
Avelumab: 10 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm E Esc Schedule-1 Dose Level 1; XRT: Starting C1D2 to C1D11
n=3 participants at risk
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks XRT: 60 Gy for 10 fractions
|
Arm E Esc Schedule-2 Dose Level 1; XRT: Starting Days -14 to -1
n=3 participants at risk
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks XRT: 60 Gy for 10 fractions
|
Arm F Esc Schedule-1 Dose Level 1; Avelumab Starting From C1D1, XRT: Starting C1D2 to C1D11
n=4 participants at risk
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
Arm F Esc Schedule-2 Dose Level 1; Avelumab Starting From C1D15, XRT: Starting Days -14 to -1
n=3 participants at risk
Avelumab: 10 mg/kg IV every 2 weeks Ivuxolimab: 0.3 mg/kg IV every 2 weeks Utomilumab: 20 mg IV every 4 weeks XRT: 60 Gy for 10 fractions
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
5.9%
1/17 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Gastrointestinal disorders
Abdominal pain
|
18.8%
3/16 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
17.6%
3/17 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
27.3%
3/11 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
57.1%
4/7 • Number of events 4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
66.7%
2/3 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
5.9%
1/17 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
18.2%
2/11 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Psychiatric disorders
Agitation
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
9.1%
1/11 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
4/16 • Number of events 4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
2/16 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
11.8%
2/17 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
9.1%
1/11 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Investigations
Alkaline phosphatase increased
|
31.2%
5/16 • Number of events 5 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
62.5%
5/8 • Number of events 5 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
2/16 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
4/12 • Number of events 4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
11.8%
2/17 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
18.2%
2/11 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
50.0%
2/4 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
28.6%
2/7 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
100.0%
3/3 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Nervous system disorders
Amnesia
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
5.9%
1/17 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Blood and lymphatic system disorders
Anemia
|
31.2%
5/16 • Number of events 5 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
75.0%
6/8 • Number of events 6 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
2/16 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
3/12 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
29.4%
5/17 • Number of events 5 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
36.4%
4/11 • Number of events 4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
75.0%
3/4 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
28.6%
2/7 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
100.0%
3/3 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
100.0%
3/3 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Metabolism and nutrition disorders
Anorexia
|
43.8%
7/16 • Number of events 7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
4/16 • Number of events 4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
3/12 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
45.5%
5/11 • Number of events 5 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
57.1%
4/7 • Number of events 4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
66.7%
2/3 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
14.3%
1/7 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Gastrointestinal disorders
Ascites
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
8.3%
1/12 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
18.2%
2/11 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Investigations
Aspartate aminotransferase increased
|
31.2%
5/16 • Number of events 5 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
62.5%
5/8 • Number of events 5 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
18.8%
3/16 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
17.6%
3/17 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
9.1%
1/11 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
75.0%
3/4 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
57.1%
4/7 • Number of events 4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
66.7%
2/3 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
2/16 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
17.6%
3/17 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
9.1%
1/11 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Hepatobiliary disorders
Bile duct stenosis
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Investigations
Blood bilirubin increased
|
31.2%
5/16 • Number of events 5 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
16.7%
2/12 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
9.1%
1/11 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
14.3%
1/7 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Cardiac disorders
Cardiac disorders - Other,
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Cardiac disorders
Cardiac troponin I increased
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
General disorders
Chills
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
2/16 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
18.2%
2/11 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
50.0%
2/4 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
66.7%
2/3 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Investigations
Cholesterol high
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
9.1%
1/11 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Psychiatric disorders
Confusion
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
8.3%
1/12 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Gastrointestinal disorders
Constipation
|
31.2%
5/16 • Number of events 5 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
2/8 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
8.3%
1/12 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
17.6%
3/17 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
18.2%
2/11 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
14.3%
1/7 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
66.7%
2/3 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.8%
3/16 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
16.7%
2/12 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
27.3%
3/11 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Investigations
CPK increased
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
37.5%
3/8 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
9.1%
1/11 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Investigations
Creatinine increased
|
12.5%
2/16 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
75.0%
6/8 • Number of events 6 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
2/16 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
17.6%
3/17 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
27.3%
3/11 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
66.7%
2/3 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
General disorders
Death NOS
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Vascular disorders
Deep vein thrombosis (left leg)
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Metabolism and nutrition disorders
Dehydration
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Psychiatric disorders
Depression
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
2/8 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
3/12 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
5.9%
1/17 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
27.3%
3/11 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
28.6%
2/7 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
66.7%
2/3 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
5.9%
1/17 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
9.1%
1/11 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
5.9%
1/17 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
43.8%
7/16 • Number of events 7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
2/8 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
18.8%
3/16 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
16.7%
2/12 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
75.0%
3/4 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
35.3%
6/17 • Number of events 6 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
36.4%
4/11 • Number of events 4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
50.0%
2/4 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
14.3%
1/7 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
General disorders
Edema limbs
|
37.5%
6/16 • Number of events 6 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
2/8 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
8.3%
1/12 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
11.8%
2/17 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
18.2%
2/11 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
28.6%
2/7 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
9.1%
1/11 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
5.9%
1/17 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Gastrointestinal disorders
epigastric pain
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
9.1%
1/11 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Eye disorders
Eye disorders - Other, specify
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
8.3%
1/12 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
General disorders
Fatigue
|
31.2%
5/16 • Number of events 5 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
37.5%
3/8 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
18.8%
3/16 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
3/12 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
75.0%
3/4 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
17.6%
3/17 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
18.2%
2/11 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
66.7%
2/3 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
42.9%
3/7 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
66.7%
2/3 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
66.7%
2/3 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
General disorders
Fever
|
18.8%
3/16 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
37.5%
3/8 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
11.8%
2/17 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
14.3%
1/7 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
General disorders
Flu like symptoms
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
General disorders
Gait disturbance
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
5.9%
1/17 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
9.1%
1/11 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
8.3%
1/12 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
5.9%
1/17 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
14.3%
1/7 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Gastrointestinal disorders
Gastroparesis
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
5.9%
1/17 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
18.2%
2/11 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
9.1%
1/11 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Nervous system disorders
Headache
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
8.3%
1/12 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
11.8%
2/17 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
18.2%
2/11 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
9.1%
1/11 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Vascular disorders
Hot flashes
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
5.9%
1/17 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
12.5%
2/16 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
37.5%
3/8 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
2/16 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
16.7%
2/12 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
11.8%
2/17 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
75.0%
3/4 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
18.2%
2/11 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
5.9%
1/17 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Vascular disorders
Hypertension
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
9.1%
1/11 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Eye disorders
hyperthyroidism
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
8.3%
1/12 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
9.1%
1/11 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
8.3%
1/12 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
17.6%
3/17 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
25.0%
4/16 • Number of events 4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
8.3%
1/12 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
5.9%
1/17 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
9.1%
1/11 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
75.0%
3/4 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
14.3%
1/7 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
66.7%
2/3 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
5.9%
1/17 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
2/8 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
8.3%
1/12 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
11.8%
2/17 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
18.2%
2/11 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
50.0%
2/4 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
18.2%
2/11 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
50.0%
2/4 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
66.7%
2/3 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
2/8 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
18.8%
3/16 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
4/12 • Number of events 4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
17.6%
3/17 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
9.1%
1/11 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
75.0%
3/4 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
66.7%
2/3 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
75.0%
3/4 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
8.3%
1/12 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
5.9%
1/17 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
9.1%
1/11 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
50.0%
2/4 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Vascular disorders
Hypotension
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
14.3%
1/7 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
14.3%
1/7 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
42.9%
3/7 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
General disorders
Infusion related reaction
|
12.5%
2/16 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
8.3%
1/12 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
23.5%
4/17 • Number of events 4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
28.6%
2/7 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Investigations
INR increased
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
9.1%
1/11 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Psychiatric disorders
Insomnia
|
25.0%
4/16 • Number of events 4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
27.3%
3/11 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
28.6%
2/7 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Investigations
Investigations - Other, specify
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Investigations
Lipase increased
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
100.0%
8/8 • Number of events 8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
16.7%
2/12 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
11.8%
2/17 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
50.0%
2/4 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Infections and infestations
Lung infection
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
66.7%
2/3 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Vascular disorders
Lymphedema
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
8.3%
1/12 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
5.9%
1/17 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
9.1%
1/11 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
50.0%
2/4 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
9.1%
1/11 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
8.3%
1/12 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
9.1%
1/11 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
18.2%
2/11 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Gastrointestinal disorders
Nausea
|
25.0%
4/16 • Number of events 4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
37.5%
3/8 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
8.3%
1/12 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
11.8%
2/17 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
42.9%
3/7 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Investigations
Neutrophil count decreased
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
General disorders
Non-cardiac chest pain
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
General disorders
Pain
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
11.8%
2/17 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
18.2%
2/11 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
28.6%
2/7 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
5.9%
1/17 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Cardiac disorders
Palpitations
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Investigations
Pancreatic enzymes decreased
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
5.9%
1/17 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
2/8 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
9.1%
1/11 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
9.1%
1/11 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Investigations
Platelet count decreased
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
8.3%
1/12 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
50.0%
2/4 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
14.3%
1/7 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
66.7%
2/3 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
8.3%
1/12 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
11.8%
2/17 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
14.3%
1/7 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
5.9%
1/17 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
5.9%
1/17 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
18.2%
2/11 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Psychiatric disorders
Psychiatric disorders - Adjustment disorder with depressive mood
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
18.8%
3/16 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
3/12 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
11.8%
2/17 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
18.2%
2/11 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
66.7%
2/3 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Infections and infestations
Rash pustular
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
8.3%
1/12 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Gastrointestinal disorders
Rectal fistula
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
37.5%
3/8 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
8.3%
1/12 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
27.3%
3/11 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
14.3%
1/7 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Investigations
Serum amylase increased
|
12.5%
2/16 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
37.5%
3/8 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
5.9%
1/17 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
50.0%
2/4 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Injury, poisoning and procedural complications
Sinusitis
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
37.5%
3/8 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
9.1%
1/11 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
14.3%
1/7 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Infections and infestations
Skin infection
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
8.3%
1/12 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Nervous system disorders
Somnolence
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
8.3%
1/12 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
2/8 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
General disorders
Sprain: left ankle
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
9.1%
1/11 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
General disorders
Swelling: left ankle
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
9.1%
1/11 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
9.1%
1/11 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
11.8%
2/17 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
9.1%
1/11 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
9.1%
1/11 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
9.1%
1/11 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
9.1%
1/11 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Infections and infestations
Urinary tract infection
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
8.3%
1/12 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
11.8%
2/17 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Reproductive system and breast disorders
Vaginal discharge
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
8.3%
1/12 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
16.7%
2/12 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
11.8%
2/17 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
28.6%
2/7 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Investigations
Weight loss
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
5.9%
1/17 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
9.1%
1/11 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Investigations
White blood cell decreased
|
18.8%
3/16 • Number of events 3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
12.5%
1/8 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
8.3%
1/12 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
25.0%
1/4 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
28.6%
2/7 • Number of events 2 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
33.3%
1/3 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
|
Infections and infestations
Wound infection
|
6.2%
1/16 • Number of events 1 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/8 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/16 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/12 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/17 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/11 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/7 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/4 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
0.00%
0/3 • First day of administration of study medication through 30 calendar days after the last administration of the investigational product, through the end of the study up to 3 years.
All AEs were reported regardless of treatment group or relationship to the investigational product(s). AEs were graded per NCI CTCAE v4.03. Every attempt was made to report all SAEs, expected or unexpected, to the IND Office, regardless of attribution within 5 working days and all life-threatening or fatal events, that were unexpected, and related to the study drug within 24 hours (next working day) of knowledge of the event to the Safety Project Manager in the IND Office
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place