Trial Outcomes & Findings for Study of Anti-PD-L1 in Combination With Chemo(Radio)Therapy for Oesophageal Cancer (NCT NCT02735239)
NCT ID: NCT02735239
Last Updated: 2024-03-22
Results Overview
Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Adverse events (AEs) were reported based on clinical laboratory tests, vital signs, physical examinations, and any other medically indicated assessments, including subject interviews, from the time informed consent is signed through 110 days after the last dose of study treatment. Treatment-emergent AEs were those that occurred or worsened after administration of the first dose of study treatment. In Cohorts A1, A2 and B, 12, 5 and 7 subjects, respectively, were monitored for dose limiting toxicities (DLTs) during the first 10 weeks of treatment (DLT evaluation period).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
73 participants
Primary outcome timeframe
up to 1 year
Results posted on
2024-03-22
Participant Flow
Participant milestones
| Measure |
Cohort A1: Metastatic/Locally Advanced OC, Durva + Chemotherapy (Chemo)
Durvalumab (750 mg IV every two weeks \[Q2W\]) was to be given for up to 11 doses. Oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy was started on the day of the third dose of durvalumab and continued for 6 doses.
Durvalumab: Anti PD-L1 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort A2: Metastatic/Locally Advanced OC, Durva, Treme + Chemo
Durvalumab (750 mg IV Q2W) was to be given for up to 11 doses. One dose of tremelimumab (37.5 mg IV) was given on the same day as the first dose of durvalumab. Oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy was started on the day of the third dose of durvalumab and continued for 6 doses.
Durvalumab: Anti PD-L1 antibody
Tremelimumab: Anti CTLA-4 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort B: Metastatic/Locally Advanced OC, Durva, Treme + Chemo
Durvalumab (750 mg IV Q2W) was to be given for up to 11 doses. One dose of tremelimumab (75 mg IV) was given on the same day as the first dose of durvalumab. Oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy was started on the day of the third dose of durvalumab and continued for 6 doses.
Durvalumab: Anti PD-L1 antibody
Tremelimumab: Anti CTLA-4 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort C: Operable OC; Durva + Chemo
Durvalumab (750 mg IV Q2W) was to be given for up to 5 doses. Two cycles of neoadjuvant oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy were to be administered before surgery. Subjects were to undergo surgery 6 to 8 weeks after completing chemotherapy or according to institutional policies for surgery; and would be eligible to resume durvalumab dosing (to a maximum of 12 infusions) once recovered from surgery, provided that this was within 3 months of surgery.
Durvalumab: Anti PD-L1 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort C-FLOT: Operable OC, Durva + FLOT Chemotherapy
Durvalumab (750 mg IV Q2W) was to be given for up to 6 doses. Two cycles of neoadjuvant 5-fluorouracil (5-FU) (2600 mg/m\^2 24-hr IV), leucovorin (200 mg/m\^2 IV), oxaliplatin (85 mg/m\^2 IV), and docetaxel (50 mg/m\^2 IV) chemotherapy (FLOT) were to be administered before surgery starting on the day of the third dose of durvalumab. Subjects were to undergo surgery 6 to 8 weeks after completing chemotherapy or according to institutional policies for surgery; and would be eligible to resume durvalumab dosing (to a maximum of 12 infusions), FLOT or durvalumab plus FLOT at the discretion of the Investigator once recovered from surgery, provided that this was within 3 months of surgery.
Durvalumab: Anti PD-L1 antibody
5-fluorouracil (5-FU): IV administered chemotherapy
Oxaliplatin: IV administered chemotherapy
Leucovorin: chemo-protective agent
Docetaxel: IV administered chemotherapy
|
Cohort D/D2: Operable OC, Durva + Neoadjuvant Chemo(Radio)Therapy
Durvalumab (750 mg IV Q2W) was to be given for 2 doses. This was followed by five weekly doses of neoadjuvant paclitaxel (50 mg/m\^2 IV) / carboplatin (AUC 2) IV chemotherapy + radiotherapy (41.4 Gy radiotherapy given over 23 fractions) before surgery. Subjects could receive an additional dose of durvalumab after completion of chemoradiation.
In Cohort D2, subjects continued durvalumab for 3 additional doses while receiving chemoradiation. Subjects were to undergo surgery 6 to 8 weeks after completing chemo(radio)therapy or according to institutional policies for surgery; and would be eligible to resume durvalumab dosing (to a maximum of 12 infusions) once recovered from surgery, provided that this was within 3 months of surgery.
Durvalumab: Anti PD-L1 antibody
Radiotherapy
Paclitaxel: IV administered chemotherapy
Carboplatin: IV administered chemotherapy
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
5
|
21
|
11
|
9
|
15
|
|
Overall Study
COMPLETED
|
8
|
2
|
13
|
11
|
9
|
13
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
8
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Cohort A1: Metastatic/Locally Advanced OC, Durva + Chemotherapy (Chemo)
Durvalumab (750 mg IV every two weeks \[Q2W\]) was to be given for up to 11 doses. Oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy was started on the day of the third dose of durvalumab and continued for 6 doses.
Durvalumab: Anti PD-L1 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort A2: Metastatic/Locally Advanced OC, Durva, Treme + Chemo
Durvalumab (750 mg IV Q2W) was to be given for up to 11 doses. One dose of tremelimumab (37.5 mg IV) was given on the same day as the first dose of durvalumab. Oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy was started on the day of the third dose of durvalumab and continued for 6 doses.
Durvalumab: Anti PD-L1 antibody
Tremelimumab: Anti CTLA-4 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort B: Metastatic/Locally Advanced OC, Durva, Treme + Chemo
Durvalumab (750 mg IV Q2W) was to be given for up to 11 doses. One dose of tremelimumab (75 mg IV) was given on the same day as the first dose of durvalumab. Oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy was started on the day of the third dose of durvalumab and continued for 6 doses.
Durvalumab: Anti PD-L1 antibody
Tremelimumab: Anti CTLA-4 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort C: Operable OC; Durva + Chemo
Durvalumab (750 mg IV Q2W) was to be given for up to 5 doses. Two cycles of neoadjuvant oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy were to be administered before surgery. Subjects were to undergo surgery 6 to 8 weeks after completing chemotherapy or according to institutional policies for surgery; and would be eligible to resume durvalumab dosing (to a maximum of 12 infusions) once recovered from surgery, provided that this was within 3 months of surgery.
Durvalumab: Anti PD-L1 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort C-FLOT: Operable OC, Durva + FLOT Chemotherapy
Durvalumab (750 mg IV Q2W) was to be given for up to 6 doses. Two cycles of neoadjuvant 5-fluorouracil (5-FU) (2600 mg/m\^2 24-hr IV), leucovorin (200 mg/m\^2 IV), oxaliplatin (85 mg/m\^2 IV), and docetaxel (50 mg/m\^2 IV) chemotherapy (FLOT) were to be administered before surgery starting on the day of the third dose of durvalumab. Subjects were to undergo surgery 6 to 8 weeks after completing chemotherapy or according to institutional policies for surgery; and would be eligible to resume durvalumab dosing (to a maximum of 12 infusions), FLOT or durvalumab plus FLOT at the discretion of the Investigator once recovered from surgery, provided that this was within 3 months of surgery.
Durvalumab: Anti PD-L1 antibody
5-fluorouracil (5-FU): IV administered chemotherapy
Oxaliplatin: IV administered chemotherapy
Leucovorin: chemo-protective agent
Docetaxel: IV administered chemotherapy
|
Cohort D/D2: Operable OC, Durva + Neoadjuvant Chemo(Radio)Therapy
Durvalumab (750 mg IV Q2W) was to be given for 2 doses. This was followed by five weekly doses of neoadjuvant paclitaxel (50 mg/m\^2 IV) / carboplatin (AUC 2) IV chemotherapy + radiotherapy (41.4 Gy radiotherapy given over 23 fractions) before surgery. Subjects could receive an additional dose of durvalumab after completion of chemoradiation.
In Cohort D2, subjects continued durvalumab for 3 additional doses while receiving chemoradiation. Subjects were to undergo surgery 6 to 8 weeks after completing chemo(radio)therapy or according to institutional policies for surgery; and would be eligible to resume durvalumab dosing (to a maximum of 12 infusions) once recovered from surgery, provided that this was within 3 months of surgery.
Durvalumab: Anti PD-L1 antibody
Radiotherapy
Paclitaxel: IV administered chemotherapy
Carboplatin: IV administered chemotherapy
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
4
|
0
|
0
|
0
|
|
Overall Study
Death
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Progressive disease
|
3
|
1
|
3
|
0
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Study of Anti-PD-L1 in Combination With Chemo(Radio)Therapy for Oesophageal Cancer
Baseline characteristics by cohort
| Measure |
Cohort A1: Metastatic/Locally Advanced OC, Durva + Chemotherapy (Chemo)
n=12 Participants
Durvalumab (750 mg IV every two weeks \[Q2W\]) was to be given for up to 11 doses. Oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy was started on the day of the third dose of durvalumab and continued for 6 doses.
Durvalumab: Anti PD-L1 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort A2: Metastatic/Locally Advanced OC, Durva, Treme + Chemo
n=5 Participants
Durvalumab (750 mg IV Q2W) was to be given for up to 11 doses. One dose of tremelimumab (37.5 mg IV) was given on the same day as the first dose of durvalumab. Oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy was started on the day of the third dose of durvalumab and continued for 6 doses.
Durvalumab: Anti PD-L1 antibody
Tremelimumab: Anti CTLA-4 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort B: Metastatic/Locally Advanced OC, Durva, Treme + Chemo
n=21 Participants
Durvalumab (750 mg IV Q2W) was to be given for up to 11 doses. One dose of tremelimumab (75 mg IV) was given on the same day as the first dose of durvalumab. Oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy was started on the day of the third dose of durvalumab and continued for 6 doses.
Durvalumab: Anti PD-L1 antibody
Tremelimumab: Anti CTLA-4 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort C: Operable OC; Durva + Chemo
n=11 Participants
Durvalumab (750 mg IV Q2W) was to be given for up to 5 doses. Two cycles of neoadjuvant oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy were to be administered before surgery. Subjects were to undergo surgery 6 to 8 weeks after completing chemotherapy or according to institutional policies for surgery; and would be eligible to resume durvalumab dosing (to a maximum of 12 infusions) once recovered from surgery, provided that this was within 3 months of surgery.
Durvalumab: Anti PD-L1 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort C-FLOT: Operable OC, Durva + FLOT Chemotherapy
n=9 Participants
Durvalumab (750 mg IV Q2W) was to be given for up to 6 doses. Two cycles of neoadjuvant 5-fluorouracil (5-FU) (2600 mg/m\^2 24-hr IV), leucovorin (200 mg/m\^2 IV), oxaliplatin (85 mg/m\^2 IV), and docetaxel (50 mg/m\^2 IV) chemotherapy (FLOT) were to be administered before surgery starting on the day of the third dose of durvalumab. Subjects were to undergo surgery 6 to 8 weeks after completing chemotherapy or according to institutional policies for surgery; and would be eligible to resume durvalumab dosing (to a maximum of 12 infusions), FLOT or durvalumab plus FLOT at the discretion of the Investigator once recovered from surgery, provided that this was within 3 months of surgery.
Durvalumab: Anti PD-L1 antibody
5-fluorouracil (5-FU): IV administered chemotherapy
Oxaliplatin: IV administered chemotherapy
Leucovorin: chemo-protective agent
Docetaxel: IV administered chemotherapy
|
Cohort D/D2: Operable OC, Durva + Neoadjuvant Chemo(Radio)Therapy
n=15 Participants
Durvalumab (750 mg IV Q2W) was to be given for 2 doses. This was followed by five weekly doses of neoadjuvant paclitaxel (50 mg/m\^2 IV) / carboplatin (AUC 2) IV chemotherapy + radiotherapy (41.4 Gy radiotherapy given over 23 fractions) before surgery. Subjects could receive an additional dose of durvalumab after completion of chemoradiation.
In Cohort D2, subjects continued durvalumab for 3 additional doses while receiving chemoradiation. Subjects were to undergo surgery 6 to 8 weeks after completing chemo(radio)therapy or according to institutional policies for surgery; and would be eligible to resume durvalumab dosing (to a maximum of 12 infusions) once recovered from surgery, provided that this was within 3 months of surgery.
Durvalumab: Anti PD-L1 antibody
Radiotherapy
Paclitaxel: IV administered chemotherapy
Carboplatin: IV administered chemotherapy
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
59.5 years
n=5 Participants
|
55.0 years
n=7 Participants
|
58.0 years
n=5 Participants
|
57 years
n=4 Participants
|
56 years
n=21 Participants
|
65 years
n=8 Participants
|
59 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
62 Participants
n=8 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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=8 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
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
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
70 Participants
n=8 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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
|
Region of Enrollment
United Kingdom
|
12 participants
n=5 Participants
|
5 participants
n=7 Participants
|
21 participants
n=5 Participants
|
11 participants
n=4 Participants
|
9 participants
n=21 Participants
|
15 participants
n=8 Participants
|
73 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: up to 1 yearPopulation: All subjects who received at least one dose of study treatment.
Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Adverse events (AEs) were reported based on clinical laboratory tests, vital signs, physical examinations, and any other medically indicated assessments, including subject interviews, from the time informed consent is signed through 110 days after the last dose of study treatment. Treatment-emergent AEs were those that occurred or worsened after administration of the first dose of study treatment. In Cohorts A1, A2 and B, 12, 5 and 7 subjects, respectively, were monitored for dose limiting toxicities (DLTs) during the first 10 weeks of treatment (DLT evaluation period).
Outcome measures
| Measure |
Cohort A1: Metastatic/Locally Advanced OC, Durva + Chemotherapy (Chemo)
n=12 Participants
Durvalumab (750 mg IV every two weeks \[Q2W\]) was to be given for up to 11 doses. Oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy was started on the day of the third dose of durvalumab and continued for 6 doses.
Durvalumab: Anti PD-L1 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort A2: Metastatic/Locally Advanced OC, Durva, Treme + Chemo
n=5 Participants
Durvalumab (750 mg IV Q2W) was to be given for up to 11 doses. One dose of tremelimumab (37.5 mg IV) was given on the same day as the first dose of durvalumab. Oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy was started on the day of the third dose of durvalumab and continued for 6 doses.
Durvalumab: Anti PD-L1 antibody
Tremelimumab: Anti CTLA-4 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort B: Metastatic/Locally Advanced OC, Durva, Treme + Chemo
n=21 Participants
Durvalumab (750 mg IV Q2W) was to be given for up to 11 doses. One dose of tremelimumab (75 mg IV) was given on the same day as the first dose of durvalumab. Oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy was started on the day of the third dose of durvalumab and continued for 6 doses.
Durvalumab: Anti PD-L1 antibody
Tremelimumab: Anti CTLA-4 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort C: Operable OC; Durva + Chemo
n=11 Participants
Durvalumab (750 mg IV Q2W) was to be given for up to 5 doses. Two cycles of neoadjuvant oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy were to be administered before surgery. Subjects were to undergo surgery 6 to 8 weeks after completing chemotherapy or according to institutional policies for surgery; and would be eligible to resume durvalumab dosing (to a maximum of 12 infusions) once recovered from surgery, provided that this was within 3 months of surgery.
Durvalumab: Anti PD-L1 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort C-FLOT: Operable OC, Durva + FLOT Chemotherapy
n=9 Participants
Durvalumab (750 mg IV Q2W) was to be given for up to 6 doses. Two cycles of neoadjuvant 5-fluorouracil (5-FU) (2600 mg/m\^2 24-hr IV), leucovorin (200 mg/m\^2 IV), oxaliplatin (85 mg/m\^2 IV), and docetaxel (50 mg/m\^2 IV) chemotherapy (FLOT) were to be administered before surgery starting on the day of the third dose of durvalumab. Subjects were to undergo surgery 6 to 8 weeks after completing chemotherapy or according to institutional policies for surgery; and would be eligible to resume durvalumab dosing (to a maximum of 12 infusions), FLOT or durvalumab plus FLOT at the discretion of the Investigator once recovered from surgery, provided that this was within 3 months of surgery.
Durvalumab: Anti PD-L1 antibody
5-fluorouracil (5-FU): IV administered chemotherapy
Oxaliplatin: IV administered chemotherapy
Leucovorin: chemo-protective agent
Docetaxel: IV administered chemotherapy
|
Cohort D/D2: Operable OC, Durva + Neoadjuvant Chemo(Radio)Therapy
n=15 Participants
Durvalumab (750 mg IV Q2W) was to be given for 2 doses. This was followed by five weekly doses of neoadjuvant paclitaxel (50 mg/m\^2 IV) / carboplatin (AUC 2) IV chemotherapy + radiotherapy (41.4 Gy radiotherapy given over 23 fractions) before surgery. Subjects could receive an additional dose of durvalumab after completion of chemoradiation.
In Cohort D2, subjects continued durvalumab for 3 additional doses while receiving chemoradiation. Subjects were to undergo surgery 6 to 8 weeks after completing chemo(radio)therapy or according to institutional policies for surgery; and would be eligible to resume durvalumab dosing (to a maximum of 12 infusions) once recovered from surgery, provided that this was within 3 months of surgery.
Durvalumab: Anti PD-L1 antibody
Radiotherapy
Paclitaxel: IV administered chemotherapy
Carboplatin: IV administered chemotherapy
|
|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Treatment Emergent Adverse Events (TEAEs)
DLTs within the 10-week DLT evaluation period
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects Reporting Treatment Emergent Adverse Events (TEAEs)
Treatment-emergent adverse events (TEAEs)
|
12 Participants
|
5 Participants
|
21 Participants
|
11 Participants
|
9 Participants
|
15 Participants
|
|
Number of Subjects Reporting Treatment Emergent Adverse Events (TEAEs)
Dose-limiting toxicities (DLTs) during the entire study
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Treatment Emergent Adverse Events (TEAEs)
Discontinued due to a TEAE
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: up to 1 yearPopulation: All subjects who received at least one dose of study treatment and had a baseline and at least one post-baseline disease assessment.
Tumor responses were evaluated using appropriate imaging and categorized according to irRECIST at Screening (up to 28 days before the first dose of study treatment), and in Cycles 1, 3, 5 and 6 in Cohorts A1, A2 and B. In the other cohorts, tumor response was assessed at baseline, post-surgery and 14 days after the last dose. In Cohorts C-FLOT and D, an additional assessment was done prior to surgery and in Cohorts C and D, an additional assessment was done in Cycle 3. Per irRECIST, measurable lesions are categorized as follows: Immune-related Complete Response (irCR): Complete disappearance of all target lesions; Immune-related Partial Response (irPR): ≥ 30% decrease from baseline in the Total Measurable Tumor Burden (TMTB); Immune-related Progressive Disease (irPD): ≥ 20% increase from nadir in TMTB; Immune-related Stable Disease (irSD): not meeting above criteria; irNon-CR/Non-PD: irNon-CR/Non-PD is preferred over SD when no lesions can be measured.
Outcome measures
| Measure |
Cohort A1: Metastatic/Locally Advanced OC, Durva + Chemotherapy (Chemo)
n=11 Participants
Durvalumab (750 mg IV every two weeks \[Q2W\]) was to be given for up to 11 doses. Oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy was started on the day of the third dose of durvalumab and continued for 6 doses.
Durvalumab: Anti PD-L1 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort A2: Metastatic/Locally Advanced OC, Durva, Treme + Chemo
n=5 Participants
Durvalumab (750 mg IV Q2W) was to be given for up to 11 doses. One dose of tremelimumab (37.5 mg IV) was given on the same day as the first dose of durvalumab. Oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy was started on the day of the third dose of durvalumab and continued for 6 doses.
Durvalumab: Anti PD-L1 antibody
Tremelimumab: Anti CTLA-4 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort B: Metastatic/Locally Advanced OC, Durva, Treme + Chemo
n=20 Participants
Durvalumab (750 mg IV Q2W) was to be given for up to 11 doses. One dose of tremelimumab (75 mg IV) was given on the same day as the first dose of durvalumab. Oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy was started on the day of the third dose of durvalumab and continued for 6 doses.
Durvalumab: Anti PD-L1 antibody
Tremelimumab: Anti CTLA-4 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort C: Operable OC; Durva + Chemo
n=9 Participants
Durvalumab (750 mg IV Q2W) was to be given for up to 5 doses. Two cycles of neoadjuvant oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy were to be administered before surgery. Subjects were to undergo surgery 6 to 8 weeks after completing chemotherapy or according to institutional policies for surgery; and would be eligible to resume durvalumab dosing (to a maximum of 12 infusions) once recovered from surgery, provided that this was within 3 months of surgery.
Durvalumab: Anti PD-L1 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort C-FLOT: Operable OC, Durva + FLOT Chemotherapy
n=5 Participants
Durvalumab (750 mg IV Q2W) was to be given for up to 6 doses. Two cycles of neoadjuvant 5-fluorouracil (5-FU) (2600 mg/m\^2 24-hr IV), leucovorin (200 mg/m\^2 IV), oxaliplatin (85 mg/m\^2 IV), and docetaxel (50 mg/m\^2 IV) chemotherapy (FLOT) were to be administered before surgery starting on the day of the third dose of durvalumab. Subjects were to undergo surgery 6 to 8 weeks after completing chemotherapy or according to institutional policies for surgery; and would be eligible to resume durvalumab dosing (to a maximum of 12 infusions), FLOT or durvalumab plus FLOT at the discretion of the Investigator once recovered from surgery, provided that this was within 3 months of surgery.
Durvalumab: Anti PD-L1 antibody
5-fluorouracil (5-FU): IV administered chemotherapy
Oxaliplatin: IV administered chemotherapy
Leucovorin: chemo-protective agent
Docetaxel: IV administered chemotherapy
|
Cohort D/D2: Operable OC, Durva + Neoadjuvant Chemo(Radio)Therapy
n=8 Participants
Durvalumab (750 mg IV Q2W) was to be given for 2 doses. This was followed by five weekly doses of neoadjuvant paclitaxel (50 mg/m\^2 IV) / carboplatin (AUC 2) IV chemotherapy + radiotherapy (41.4 Gy radiotherapy given over 23 fractions) before surgery. Subjects could receive an additional dose of durvalumab after completion of chemoradiation.
In Cohort D2, subjects continued durvalumab for 3 additional doses while receiving chemoradiation. Subjects were to undergo surgery 6 to 8 weeks after completing chemo(radio)therapy or according to institutional policies for surgery; and would be eligible to resume durvalumab dosing (to a maximum of 12 infusions) once recovered from surgery, provided that this was within 3 months of surgery.
Durvalumab: Anti PD-L1 antibody
Radiotherapy
Paclitaxel: IV administered chemotherapy
Carboplatin: IV administered chemotherapy
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Best Overall Tumor Response by the Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
Not Evaluable
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
|
Number of Subjects With Best Overall Tumor Response by the Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
irCR
|
2 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Best Overall Tumor Response by the Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
irPR
|
3 Participants
|
3 Participants
|
10 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Best Overall Tumor Response by the Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
irSD
|
5 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Best Overall Tumor Response by the Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
irPD
|
1 Participants
|
1 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Best Overall Tumor Response by the Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
irNon-CR/Non-PD
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 23 weeksPopulation: All subjects in Cohorts A1, A2 and B who received at least one dose of study treatment and had a baseline and at least one post-baseline disease assessment.
Tumor responses were evaluated using appropriate imaging and categorized according to irRECIST at Screening (up to 28 days before the first dose of study treatment), and in Cycles 1, 3, 5 and 6 in Cohorts A1, A2 and B. Per irRECIST, measurable lesions are categorized as follows: irCR: Complete disappearance of all target lesions; irPR: ≥ 30% decrease from baseline in the Total Measurable Tumor Burden (TMTB); irPD: ≥ 20% increase from nadir in TMTB; irSD: not meeting above criteria; irNon-CR/Non-PD: irNon-CR/Non-PD is preferred over SD when no lesions can be measured.
Outcome measures
| Measure |
Cohort A1: Metastatic/Locally Advanced OC, Durva + Chemotherapy (Chemo)
n=8 Participants
Durvalumab (750 mg IV every two weeks \[Q2W\]) was to be given for up to 11 doses. Oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy was started on the day of the third dose of durvalumab and continued for 6 doses.
Durvalumab: Anti PD-L1 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort A2: Metastatic/Locally Advanced OC, Durva, Treme + Chemo
n=3 Participants
Durvalumab (750 mg IV Q2W) was to be given for up to 11 doses. One dose of tremelimumab (37.5 mg IV) was given on the same day as the first dose of durvalumab. Oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy was started on the day of the third dose of durvalumab and continued for 6 doses.
Durvalumab: Anti PD-L1 antibody
Tremelimumab: Anti CTLA-4 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort B: Metastatic/Locally Advanced OC, Durva, Treme + Chemo
n=14 Participants
Durvalumab (750 mg IV Q2W) was to be given for up to 11 doses. One dose of tremelimumab (75 mg IV) was given on the same day as the first dose of durvalumab. Oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy was started on the day of the third dose of durvalumab and continued for 6 doses.
Durvalumab: Anti PD-L1 antibody
Tremelimumab: Anti CTLA-4 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort C: Operable OC; Durva + Chemo
Durvalumab (750 mg IV Q2W) was to be given for up to 5 doses. Two cycles of neoadjuvant oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy were to be administered before surgery. Subjects were to undergo surgery 6 to 8 weeks after completing chemotherapy or according to institutional policies for surgery; and would be eligible to resume durvalumab dosing (to a maximum of 12 infusions) once recovered from surgery, provided that this was within 3 months of surgery.
Durvalumab: Anti PD-L1 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort C-FLOT: Operable OC, Durva + FLOT Chemotherapy
Durvalumab (750 mg IV Q2W) was to be given for up to 6 doses. Two cycles of neoadjuvant 5-fluorouracil (5-FU) (2600 mg/m\^2 24-hr IV), leucovorin (200 mg/m\^2 IV), oxaliplatin (85 mg/m\^2 IV), and docetaxel (50 mg/m\^2 IV) chemotherapy (FLOT) were to be administered before surgery starting on the day of the third dose of durvalumab. Subjects were to undergo surgery 6 to 8 weeks after completing chemotherapy or according to institutional policies for surgery; and would be eligible to resume durvalumab dosing (to a maximum of 12 infusions), FLOT or durvalumab plus FLOT at the discretion of the Investigator once recovered from surgery, provided that this was within 3 months of surgery.
Durvalumab: Anti PD-L1 antibody
5-fluorouracil (5-FU): IV administered chemotherapy
Oxaliplatin: IV administered chemotherapy
Leucovorin: chemo-protective agent
Docetaxel: IV administered chemotherapy
|
Cohort D/D2: Operable OC, Durva + Neoadjuvant Chemo(Radio)Therapy
Durvalumab (750 mg IV Q2W) was to be given for 2 doses. This was followed by five weekly doses of neoadjuvant paclitaxel (50 mg/m\^2 IV) / carboplatin (AUC 2) IV chemotherapy + radiotherapy (41.4 Gy radiotherapy given over 23 fractions) before surgery. Subjects could receive an additional dose of durvalumab after completion of chemoradiation.
In Cohort D2, subjects continued durvalumab for 3 additional doses while receiving chemoradiation. Subjects were to undergo surgery 6 to 8 weeks after completing chemo(radio)therapy or according to institutional policies for surgery; and would be eligible to resume durvalumab dosing (to a maximum of 12 infusions) once recovered from surgery, provided that this was within 3 months of surgery.
Durvalumab: Anti PD-L1 antibody
Radiotherapy
Paclitaxel: IV administered chemotherapy
Carboplatin: IV administered chemotherapy
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Metastatic/Locally Advanced Oesophageal Cancer (OC) Who Had a Response at Cycle 6 by the Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
irCR
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Metastatic/Locally Advanced Oesophageal Cancer (OC) Who Had a Response at Cycle 6 by the Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
irPR
|
2 Participants
|
2 Participants
|
7 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Metastatic/Locally Advanced Oesophageal Cancer (OC) Who Had a Response at Cycle 6 by the Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
irSD
|
3 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Metastatic/Locally Advanced Oesophageal Cancer (OC) Who Had a Response at Cycle 6 by the Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
irPD
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Metastatic/Locally Advanced Oesophageal Cancer (OC) Who Had a Response at Cycle 6 by the Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
irNon-CR/Non-PD
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Metastatic/Locally Advanced Oesophageal Cancer (OC) Who Had a Response at Cycle 6 by the Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
Not evaluable
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: All subjects who received at least one dose of study treatment and had a baseline and at least one post-baseline disease assessment. One subject in Cohort D progressed prior to surgery and as a result was not included in the PFS after surgery assessment.
Tumor responses were evaluated using appropriate imaging and categorized according to irRECIST at Screening (up to 28 days before the first dose of study treatment), and in Cycles 1, 3, 5 and 6 in Cohorts A1, A2 and B. In the other cohorts, tumor response was assessed at baseline, post-surgery and 14 days after the last dose. In Cohorts C-FLOT and D, an additional assessment was done prior to surgery and in Cohorts C and D, an additional assessment was done in Cycle 3. In Cohorts A1, A2 and B, PFS was measured from the date of the first dose of study treatment to the date of earliest disease progression according to irRECIST or to the date of death, if disease progression did not occur. For Cohorts C, C-FLOT and D/D2, PFS is measured from the date of surgery. Per irRECIST, irPD was defined as a ≥ 20% increase from nadir in the TMTB.
Outcome measures
| Measure |
Cohort A1: Metastatic/Locally Advanced OC, Durva + Chemotherapy (Chemo)
n=12 Participants
Durvalumab (750 mg IV every two weeks \[Q2W\]) was to be given for up to 11 doses. Oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy was started on the day of the third dose of durvalumab and continued for 6 doses.
Durvalumab: Anti PD-L1 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort A2: Metastatic/Locally Advanced OC, Durva, Treme + Chemo
n=5 Participants
Durvalumab (750 mg IV Q2W) was to be given for up to 11 doses. One dose of tremelimumab (37.5 mg IV) was given on the same day as the first dose of durvalumab. Oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy was started on the day of the third dose of durvalumab and continued for 6 doses.
Durvalumab: Anti PD-L1 antibody
Tremelimumab: Anti CTLA-4 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort B: Metastatic/Locally Advanced OC, Durva, Treme + Chemo
n=21 Participants
Durvalumab (750 mg IV Q2W) was to be given for up to 11 doses. One dose of tremelimumab (75 mg IV) was given on the same day as the first dose of durvalumab. Oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy was started on the day of the third dose of durvalumab and continued for 6 doses.
Durvalumab: Anti PD-L1 antibody
Tremelimumab: Anti CTLA-4 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort C: Operable OC; Durva + Chemo
n=11 Participants
Durvalumab (750 mg IV Q2W) was to be given for up to 5 doses. Two cycles of neoadjuvant oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy were to be administered before surgery. Subjects were to undergo surgery 6 to 8 weeks after completing chemotherapy or according to institutional policies for surgery; and would be eligible to resume durvalumab dosing (to a maximum of 12 infusions) once recovered from surgery, provided that this was within 3 months of surgery.
Durvalumab: Anti PD-L1 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort C-FLOT: Operable OC, Durva + FLOT Chemotherapy
n=9 Participants
Durvalumab (750 mg IV Q2W) was to be given for up to 6 doses. Two cycles of neoadjuvant 5-fluorouracil (5-FU) (2600 mg/m\^2 24-hr IV), leucovorin (200 mg/m\^2 IV), oxaliplatin (85 mg/m\^2 IV), and docetaxel (50 mg/m\^2 IV) chemotherapy (FLOT) were to be administered before surgery starting on the day of the third dose of durvalumab. Subjects were to undergo surgery 6 to 8 weeks after completing chemotherapy or according to institutional policies for surgery; and would be eligible to resume durvalumab dosing (to a maximum of 12 infusions), FLOT or durvalumab plus FLOT at the discretion of the Investigator once recovered from surgery, provided that this was within 3 months of surgery.
Durvalumab: Anti PD-L1 antibody
5-fluorouracil (5-FU): IV administered chemotherapy
Oxaliplatin: IV administered chemotherapy
Leucovorin: chemo-protective agent
Docetaxel: IV administered chemotherapy
|
Cohort D/D2: Operable OC, Durva + Neoadjuvant Chemo(Radio)Therapy
n=14 Participants
Durvalumab (750 mg IV Q2W) was to be given for 2 doses. This was followed by five weekly doses of neoadjuvant paclitaxel (50 mg/m\^2 IV) / carboplatin (AUC 2) IV chemotherapy + radiotherapy (41.4 Gy radiotherapy given over 23 fractions) before surgery. Subjects could receive an additional dose of durvalumab after completion of chemoradiation.
In Cohort D2, subjects continued durvalumab for 3 additional doses while receiving chemoradiation. Subjects were to undergo surgery 6 to 8 weeks after completing chemo(radio)therapy or according to institutional policies for surgery; and would be eligible to resume durvalumab dosing (to a maximum of 12 infusions) once recovered from surgery, provided that this was within 3 months of surgery.
Durvalumab: Anti PD-L1 antibody
Radiotherapy
Paclitaxel: IV administered chemotherapy
Carboplatin: IV administered chemotherapy
|
|---|---|---|---|---|---|---|
|
Median Progression-free Survival (PFS) by the Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) as Estimated Using the Kaplan-Meier Method
|
8.7 months
Interval 0.9 to 29.1
|
5.2 months
Interval 1.4 to
Upper limit of the confidence interval not reached due to small number of subjects.
|
11.9 months
Interval 3.9 to 15.6
|
25.4 months
Interval 6.47 to
Upper limit of the confidence interval not reached due to small number of subjects.
|
32.03 months
Interval 2.1 to
Upper limit of the confidence interval not reached due to small number of subjects.
|
9.59 months
Upper and lower limits of the confidence interval not reached due to small number of subjects.
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: All subjects who received at least one dose of study treatment.
After completion of treatment, all subjects were followed for survival every 6 months for up to 3 years from start of treatment. OS was measured from the date of the first dose of study treatment to the date of death or last follow-up. Subjects lost to follow-up were censored on the date when they were last known to be alive. Per protocol amendment 8.0, all post study follow-up for the collection of survival data was discontinued as of June 30, 2022.
Outcome measures
| Measure |
Cohort A1: Metastatic/Locally Advanced OC, Durva + Chemotherapy (Chemo)
n=12 Participants
Durvalumab (750 mg IV every two weeks \[Q2W\]) was to be given for up to 11 doses. Oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy was started on the day of the third dose of durvalumab and continued for 6 doses.
Durvalumab: Anti PD-L1 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort A2: Metastatic/Locally Advanced OC, Durva, Treme + Chemo
n=5 Participants
Durvalumab (750 mg IV Q2W) was to be given for up to 11 doses. One dose of tremelimumab (37.5 mg IV) was given on the same day as the first dose of durvalumab. Oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy was started on the day of the third dose of durvalumab and continued for 6 doses.
Durvalumab: Anti PD-L1 antibody
Tremelimumab: Anti CTLA-4 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort B: Metastatic/Locally Advanced OC, Durva, Treme + Chemo
n=21 Participants
Durvalumab (750 mg IV Q2W) was to be given for up to 11 doses. One dose of tremelimumab (75 mg IV) was given on the same day as the first dose of durvalumab. Oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy was started on the day of the third dose of durvalumab and continued for 6 doses.
Durvalumab: Anti PD-L1 antibody
Tremelimumab: Anti CTLA-4 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort C: Operable OC; Durva + Chemo
n=11 Participants
Durvalumab (750 mg IV Q2W) was to be given for up to 5 doses. Two cycles of neoadjuvant oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy were to be administered before surgery. Subjects were to undergo surgery 6 to 8 weeks after completing chemotherapy or according to institutional policies for surgery; and would be eligible to resume durvalumab dosing (to a maximum of 12 infusions) once recovered from surgery, provided that this was within 3 months of surgery.
Durvalumab: Anti PD-L1 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort C-FLOT: Operable OC, Durva + FLOT Chemotherapy
n=9 Participants
Durvalumab (750 mg IV Q2W) was to be given for up to 6 doses. Two cycles of neoadjuvant 5-fluorouracil (5-FU) (2600 mg/m\^2 24-hr IV), leucovorin (200 mg/m\^2 IV), oxaliplatin (85 mg/m\^2 IV), and docetaxel (50 mg/m\^2 IV) chemotherapy (FLOT) were to be administered before surgery starting on the day of the third dose of durvalumab. Subjects were to undergo surgery 6 to 8 weeks after completing chemotherapy or according to institutional policies for surgery; and would be eligible to resume durvalumab dosing (to a maximum of 12 infusions), FLOT or durvalumab plus FLOT at the discretion of the Investigator once recovered from surgery, provided that this was within 3 months of surgery.
Durvalumab: Anti PD-L1 antibody
5-fluorouracil (5-FU): IV administered chemotherapy
Oxaliplatin: IV administered chemotherapy
Leucovorin: chemo-protective agent
Docetaxel: IV administered chemotherapy
|
Cohort D/D2: Operable OC, Durva + Neoadjuvant Chemo(Radio)Therapy
n=15 Participants
Durvalumab (750 mg IV Q2W) was to be given for 2 doses. This was followed by five weekly doses of neoadjuvant paclitaxel (50 mg/m\^2 IV) / carboplatin (AUC 2) IV chemotherapy + radiotherapy (41.4 Gy radiotherapy given over 23 fractions) before surgery. Subjects could receive an additional dose of durvalumab after completion of chemoradiation.
In Cohort D2, subjects continued durvalumab for 3 additional doses while receiving chemoradiation. Subjects were to undergo surgery 6 to 8 weeks after completing chemo(radio)therapy or according to institutional policies for surgery; and would be eligible to resume durvalumab dosing (to a maximum of 12 infusions) once recovered from surgery, provided that this was within 3 months of surgery.
Durvalumab: Anti PD-L1 antibody
Radiotherapy
Paclitaxel: IV administered chemotherapy
Carboplatin: IV administered chemotherapy
|
|---|---|---|---|---|---|---|
|
Median Overall Survival (OS) as Estimated Using the Kaplan-Meier Method
|
11.8 months
Interval 3.1 to
Upper limit of the confidence interval not reached due to small number of subjects.
|
8.6 months
Interval 2.7 to
Upper limit of the confidence interval not reached due to small number of subjects.
|
15.6 months
Interval 9.3 to 33.5
|
NA months
Interval 18.46 to
Median and upper limit of the confidence interval not reached due to small number of subjects.
|
NA months
Interval 8.02 to
Median and upper limit of the confidence interval not reached due to small number of subjects.
|
NA months
Interval 13.14 to
Median and upper limit of the confidence interval not reached due to small number of subjects.
|
SECONDARY outcome
Timeframe: up to 12 monthsPopulation: All subjects with Operable OC in Cohorts C, C-FLOT and D/D2 who received at least one dose of study treatment.
OS was measured from the date of the first dose of study treatment to the date of death or last follow-up. Subjects lost to follow-up were censored on the date when they were last known to be alive. Per protocol amendment 8.0, all post study follow-up for the collection of survival data was discontinued as of June 30, 2022.
Outcome measures
| Measure |
Cohort A1: Metastatic/Locally Advanced OC, Durva + Chemotherapy (Chemo)
n=11 Participants
Durvalumab (750 mg IV every two weeks \[Q2W\]) was to be given for up to 11 doses. Oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy was started on the day of the third dose of durvalumab and continued for 6 doses.
Durvalumab: Anti PD-L1 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort A2: Metastatic/Locally Advanced OC, Durva, Treme + Chemo
n=9 Participants
Durvalumab (750 mg IV Q2W) was to be given for up to 11 doses. One dose of tremelimumab (37.5 mg IV) was given on the same day as the first dose of durvalumab. Oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy was started on the day of the third dose of durvalumab and continued for 6 doses.
Durvalumab: Anti PD-L1 antibody
Tremelimumab: Anti CTLA-4 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort B: Metastatic/Locally Advanced OC, Durva, Treme + Chemo
n=15 Participants
Durvalumab (750 mg IV Q2W) was to be given for up to 11 doses. One dose of tremelimumab (75 mg IV) was given on the same day as the first dose of durvalumab. Oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy was started on the day of the third dose of durvalumab and continued for 6 doses.
Durvalumab: Anti PD-L1 antibody
Tremelimumab: Anti CTLA-4 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort C: Operable OC; Durva + Chemo
Durvalumab (750 mg IV Q2W) was to be given for up to 5 doses. Two cycles of neoadjuvant oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy were to be administered before surgery. Subjects were to undergo surgery 6 to 8 weeks after completing chemotherapy or according to institutional policies for surgery; and would be eligible to resume durvalumab dosing (to a maximum of 12 infusions) once recovered from surgery, provided that this was within 3 months of surgery.
Durvalumab: Anti PD-L1 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort C-FLOT: Operable OC, Durva + FLOT Chemotherapy
Durvalumab (750 mg IV Q2W) was to be given for up to 6 doses. Two cycles of neoadjuvant 5-fluorouracil (5-FU) (2600 mg/m\^2 24-hr IV), leucovorin (200 mg/m\^2 IV), oxaliplatin (85 mg/m\^2 IV), and docetaxel (50 mg/m\^2 IV) chemotherapy (FLOT) were to be administered before surgery starting on the day of the third dose of durvalumab. Subjects were to undergo surgery 6 to 8 weeks after completing chemotherapy or according to institutional policies for surgery; and would be eligible to resume durvalumab dosing (to a maximum of 12 infusions), FLOT or durvalumab plus FLOT at the discretion of the Investigator once recovered from surgery, provided that this was within 3 months of surgery.
Durvalumab: Anti PD-L1 antibody
5-fluorouracil (5-FU): IV administered chemotherapy
Oxaliplatin: IV administered chemotherapy
Leucovorin: chemo-protective agent
Docetaxel: IV administered chemotherapy
|
Cohort D/D2: Operable OC, Durva + Neoadjuvant Chemo(Radio)Therapy
Durvalumab (750 mg IV Q2W) was to be given for 2 doses. This was followed by five weekly doses of neoadjuvant paclitaxel (50 mg/m\^2 IV) / carboplatin (AUC 2) IV chemotherapy + radiotherapy (41.4 Gy radiotherapy given over 23 fractions) before surgery. Subjects could receive an additional dose of durvalumab after completion of chemoradiation.
In Cohort D2, subjects continued durvalumab for 3 additional doses while receiving chemoradiation. Subjects were to undergo surgery 6 to 8 weeks after completing chemo(radio)therapy or according to institutional policies for surgery; and would be eligible to resume durvalumab dosing (to a maximum of 12 infusions) once recovered from surgery, provided that this was within 3 months of surgery.
Durvalumab: Anti PD-L1 antibody
Radiotherapy
Paclitaxel: IV administered chemotherapy
Carboplatin: IV administered chemotherapy
|
|---|---|---|---|---|---|---|
|
One Year Survival Rate in Subjects With Operable OC
|
100 percent of participants
Upper and lower limits of the confidence interval not reached due to small number of subjects.
|
89 percent of participants
Interval 43.3 to 98.4
|
86.7 percent of participants
Interval 56.4 to 96.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 7monthsPopulation: All operable OC subjects in Cohorts C, C-FLOT and D/D2 who had a baseline PET scan and a PET scan prior to surgery.
18F- fluorodeoxyglucose (18F-FDG) PET scans were conducted at baseline and in Cycle 3 in Cohorts C and D, and after completion of therapy in Cohort C-FLOT and D2. Complete metabolic response: 18F-FDG-avid lesions revert to background of normal tissues in which they are located; Partial metabolic response: 30% or greater reduction in measurable tumors; Stable Metabolic Response: no visible change in metabolic activity of tumor; Progressive metabolic disease: increase in intensity or extent of tumor metabolic activity or new sites of activity.
Outcome measures
| Measure |
Cohort A1: Metastatic/Locally Advanced OC, Durva + Chemotherapy (Chemo)
n=11 Participants
Durvalumab (750 mg IV every two weeks \[Q2W\]) was to be given for up to 11 doses. Oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy was started on the day of the third dose of durvalumab and continued for 6 doses.
Durvalumab: Anti PD-L1 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort A2: Metastatic/Locally Advanced OC, Durva, Treme + Chemo
n=6 Participants
Durvalumab (750 mg IV Q2W) was to be given for up to 11 doses. One dose of tremelimumab (37.5 mg IV) was given on the same day as the first dose of durvalumab. Oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy was started on the day of the third dose of durvalumab and continued for 6 doses.
Durvalumab: Anti PD-L1 antibody
Tremelimumab: Anti CTLA-4 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort B: Metastatic/Locally Advanced OC, Durva, Treme + Chemo
n=13 Participants
Durvalumab (750 mg IV Q2W) was to be given for up to 11 doses. One dose of tremelimumab (75 mg IV) was given on the same day as the first dose of durvalumab. Oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy was started on the day of the third dose of durvalumab and continued for 6 doses.
Durvalumab: Anti PD-L1 antibody
Tremelimumab: Anti CTLA-4 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort C: Operable OC; Durva + Chemo
Durvalumab (750 mg IV Q2W) was to be given for up to 5 doses. Two cycles of neoadjuvant oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy were to be administered before surgery. Subjects were to undergo surgery 6 to 8 weeks after completing chemotherapy or according to institutional policies for surgery; and would be eligible to resume durvalumab dosing (to a maximum of 12 infusions) once recovered from surgery, provided that this was within 3 months of surgery.
Durvalumab: Anti PD-L1 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort C-FLOT: Operable OC, Durva + FLOT Chemotherapy
Durvalumab (750 mg IV Q2W) was to be given for up to 6 doses. Two cycles of neoadjuvant 5-fluorouracil (5-FU) (2600 mg/m\^2 24-hr IV), leucovorin (200 mg/m\^2 IV), oxaliplatin (85 mg/m\^2 IV), and docetaxel (50 mg/m\^2 IV) chemotherapy (FLOT) were to be administered before surgery starting on the day of the third dose of durvalumab. Subjects were to undergo surgery 6 to 8 weeks after completing chemotherapy or according to institutional policies for surgery; and would be eligible to resume durvalumab dosing (to a maximum of 12 infusions), FLOT or durvalumab plus FLOT at the discretion of the Investigator once recovered from surgery, provided that this was within 3 months of surgery.
Durvalumab: Anti PD-L1 antibody
5-fluorouracil (5-FU): IV administered chemotherapy
Oxaliplatin: IV administered chemotherapy
Leucovorin: chemo-protective agent
Docetaxel: IV administered chemotherapy
|
Cohort D/D2: Operable OC, Durva + Neoadjuvant Chemo(Radio)Therapy
Durvalumab (750 mg IV Q2W) was to be given for 2 doses. This was followed by five weekly doses of neoadjuvant paclitaxel (50 mg/m\^2 IV) / carboplatin (AUC 2) IV chemotherapy + radiotherapy (41.4 Gy radiotherapy given over 23 fractions) before surgery. Subjects could receive an additional dose of durvalumab after completion of chemoradiation.
In Cohort D2, subjects continued durvalumab for 3 additional doses while receiving chemoradiation. Subjects were to undergo surgery 6 to 8 weeks after completing chemo(radio)therapy or according to institutional policies for surgery; and would be eligible to resume durvalumab dosing (to a maximum of 12 infusions) once recovered from surgery, provided that this was within 3 months of surgery.
Durvalumab: Anti PD-L1 antibody
Radiotherapy
Paclitaxel: IV administered chemotherapy
Carboplatin: IV administered chemotherapy
|
|---|---|---|---|---|---|---|
|
Overall Response Prior to Surgery in Operable OC (Cohorts C, C-FLOT and D/D2) Using Positron Emission Tomography (PET) Response Criteria in Solid Tumors (PERCIST)
Complete Metabolic Response
|
2 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Overall Response Prior to Surgery in Operable OC (Cohorts C, C-FLOT and D/D2) Using Positron Emission Tomography (PET) Response Criteria in Solid Tumors (PERCIST)
Partial Metabolic Response
|
5 Participants
|
3 Participants
|
7 Participants
|
—
|
—
|
—
|
|
Overall Response Prior to Surgery in Operable OC (Cohorts C, C-FLOT and D/D2) Using Positron Emission Tomography (PET) Response Criteria in Solid Tumors (PERCIST)
Stable Disease
|
1 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Overall Response Prior to Surgery in Operable OC (Cohorts C, C-FLOT and D/D2) Using Positron Emission Tomography (PET) Response Criteria in Solid Tumors (PERCIST)
Progressive Disease
|
3 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
Adverse Events
Cohort A1: Metastatic/Locally Advanced OC, Durva + Chemotherapy (Chemo)
Serious events: 7 serious events
Other events: 12 other events
Deaths: 9 deaths
Cohort A2: Metastatic/Locally Advanced OC, Durva, Treme + Chemo
Serious events: 4 serious events
Other events: 5 other events
Deaths: 5 deaths
Cohort B: Metastatic/Locally Advanced OC, Durva, Treme + Chemo
Serious events: 12 serious events
Other events: 21 other events
Deaths: 16 deaths
Cohort C: Operable OC; Durva + Chemo
Serious events: 7 serious events
Other events: 11 other events
Deaths: 5 deaths
Cohort C-FLOT: Operable OC, Durva + FLOT Chemotherapy
Serious events: 6 serious events
Other events: 9 other events
Deaths: 2 deaths
Cohort D/D2: Operable OC, Durva + Neoadjuvant Chemo(Radio)Therapy
Serious events: 10 serious events
Other events: 15 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Cohort A1: Metastatic/Locally Advanced OC, Durva + Chemotherapy (Chemo)
n=12 participants at risk
Durvalumab (750 mg IV every two weeks \[Q2W\]) was to be given for up to 11 doses. Oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy was started on the day of the third dose of durvalumab and continued for 6 doses.
Durvalumab: Anti PD-L1 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort A2: Metastatic/Locally Advanced OC, Durva, Treme + Chemo
n=5 participants at risk
Durvalumab (750 mg IV Q2W) was to be given for up to 11 doses. One dose of tremelimumab (37.5 mg IV) was given on the same day as the first dose of durvalumab. Oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy was started on the day of the third dose of durvalumab and continued for 6 doses.
Durvalumab: Anti PD-L1 antibody
Tremelimumab: Anti CTLA-4 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort B: Metastatic/Locally Advanced OC, Durva, Treme + Chemo
n=21 participants at risk
Durvalumab (750 mg IV Q2W) was to be given for up to 11 doses. One dose of tremelimumab (75 mg IV) was given on the same day as the first dose of durvalumab. Oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy was started on the day of the third dose of durvalumab and continued for 6 doses.
Durvalumab: Anti PD-L1 antibody
Tremelimumab: Anti CTLA-4 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort C: Operable OC; Durva + Chemo
n=11 participants at risk
Durvalumab (750 mg IV Q2W) was to be given for up to 5 doses. Two cycles of neoadjuvant oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy were to be administered before surgery. Subjects were to undergo surgery 6 to 8 weeks after completing chemotherapy or according to institutional policies for surgery; and would be eligible to resume durvalumab dosing (to a maximum of 12 infusions) once recovered from surgery, provided that this was within 3 months of surgery.
Durvalumab: Anti PD-L1 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort C-FLOT: Operable OC, Durva + FLOT Chemotherapy
n=9 participants at risk
Durvalumab (750 mg IV Q2W) was to be given for up to 6 doses. Two cycles of neoadjuvant 5-fluorouracil (5-FU) (2600 mg/m\^2 24-hr IV), leucovorin (200 mg/m\^2 IV), oxaliplatin (85 mg/m\^2 IV), and docetaxel (50 mg/m\^2 IV) chemotherapy (FLOT) were to be administered before surgery starting on the day of the third dose of durvalumab. Subjects were to undergo surgery 6 to 8 weeks after completing chemotherapy or according to institutional policies for surgery; and would be eligible to resume durvalumab dosing (to a maximum of 12 infusions), FLOT or durvalumab plus FLOT at the discretion of the Investigator once recovered from surgery, provided that this was within 3 months of surgery.
Durvalumab: Anti PD-L1 antibody
5-fluorouracil (5-FU): IV administered chemotherapy
Oxaliplatin: IV administered chemotherapy
Leucovorin: chemo-protective agent
Docetaxel: IV administered chemotherapy
|
Cohort D/D2: Operable OC, Durva + Neoadjuvant Chemo(Radio)Therapy
n=15 participants at risk
Durvalumab (750 mg IV Q2W) was to be given for 2 doses. This was followed by five weekly doses of neoadjuvant paclitaxel (50 mg/m\^2 IV) / carboplatin (AUC 2) IV chemotherapy + radiotherapy (41.4 Gy radiotherapy given over 23 fractions) before surgery. Subjects could receive an additional dose of durvalumab after completion of chemoradiation.
In Cohort D2, subjects continued durvalumab for 3 additional doses while receiving chemoradiation. Subjects were to undergo surgery 6 to 8 weeks after completing chemo(radio)therapy or according to institutional policies for surgery; and would be eligible to resume durvalumab dosing (to a maximum of 12 infusions) once recovered from surgery, provided that this was within 3 months of surgery.
Durvalumab: Anti PD-L1 antibody
Radiotherapy
Paclitaxel: IV administered chemotherapy
Carboplatin: IV administered chemotherapy
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.5%
2/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
20.0%
1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Colitis
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.5%
2/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
2/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Haematemesis
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.5%
2/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
40.0%
2/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Dysphagia
|
16.7%
2/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.5%
2/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
20.0%
3/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
20.0%
1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
General disorders
Fatigue
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
General disorders
Pyrexia
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
13.3%
2/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Infections and infestations
Lower respiratory tract infection
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Infections and infestations
Orchitis
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
20.0%
1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
13.3%
2/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Infections and infestations
Sepsis
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
20.0%
1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
20.0%
1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Infections and infestations
Urinary tract infection
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Infections and infestations
Infection
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
22.2%
2/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
2/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
16.7%
2/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
20.0%
1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
19.0%
4/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Nervous system disorders
Encephalitis autoimmune
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
20.0%
1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Renal and urinary disorders
Urinary retention
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Surgical and medical procedures
Oesophagectomy
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Vascular disorders
Embolism
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Surgical and medical procedures
Jejunostomy refashioning
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Nervous system disorders
Seizure
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
Other adverse events
| Measure |
Cohort A1: Metastatic/Locally Advanced OC, Durva + Chemotherapy (Chemo)
n=12 participants at risk
Durvalumab (750 mg IV every two weeks \[Q2W\]) was to be given for up to 11 doses. Oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy was started on the day of the third dose of durvalumab and continued for 6 doses.
Durvalumab: Anti PD-L1 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort A2: Metastatic/Locally Advanced OC, Durva, Treme + Chemo
n=5 participants at risk
Durvalumab (750 mg IV Q2W) was to be given for up to 11 doses. One dose of tremelimumab (37.5 mg IV) was given on the same day as the first dose of durvalumab. Oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy was started on the day of the third dose of durvalumab and continued for 6 doses.
Durvalumab: Anti PD-L1 antibody
Tremelimumab: Anti CTLA-4 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort B: Metastatic/Locally Advanced OC, Durva, Treme + Chemo
n=21 participants at risk
Durvalumab (750 mg IV Q2W) was to be given for up to 11 doses. One dose of tremelimumab (75 mg IV) was given on the same day as the first dose of durvalumab. Oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy was started on the day of the third dose of durvalumab and continued for 6 doses.
Durvalumab: Anti PD-L1 antibody
Tremelimumab: Anti CTLA-4 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort C: Operable OC; Durva + Chemo
n=11 participants at risk
Durvalumab (750 mg IV Q2W) was to be given for up to 5 doses. Two cycles of neoadjuvant oxaliplatin (130 mg/m\^2 IV)/capecitabine (1250 mg/m\^2/day given orally) chemotherapy were to be administered before surgery. Subjects were to undergo surgery 6 to 8 weeks after completing chemotherapy or according to institutional policies for surgery; and would be eligible to resume durvalumab dosing (to a maximum of 12 infusions) once recovered from surgery, provided that this was within 3 months of surgery.
Durvalumab: Anti PD-L1 antibody
Oxaliplatin: IV administered chemotherapy
Capecitabine: orally-administered chemotherapy
|
Cohort C-FLOT: Operable OC, Durva + FLOT Chemotherapy
n=9 participants at risk
Durvalumab (750 mg IV Q2W) was to be given for up to 6 doses. Two cycles of neoadjuvant 5-fluorouracil (5-FU) (2600 mg/m\^2 24-hr IV), leucovorin (200 mg/m\^2 IV), oxaliplatin (85 mg/m\^2 IV), and docetaxel (50 mg/m\^2 IV) chemotherapy (FLOT) were to be administered before surgery starting on the day of the third dose of durvalumab. Subjects were to undergo surgery 6 to 8 weeks after completing chemotherapy or according to institutional policies for surgery; and would be eligible to resume durvalumab dosing (to a maximum of 12 infusions), FLOT or durvalumab plus FLOT at the discretion of the Investigator once recovered from surgery, provided that this was within 3 months of surgery.
Durvalumab: Anti PD-L1 antibody
5-fluorouracil (5-FU): IV administered chemotherapy
Oxaliplatin: IV administered chemotherapy
Leucovorin: chemo-protective agent
Docetaxel: IV administered chemotherapy
|
Cohort D/D2: Operable OC, Durva + Neoadjuvant Chemo(Radio)Therapy
n=15 participants at risk
Durvalumab (750 mg IV Q2W) was to be given for 2 doses. This was followed by five weekly doses of neoadjuvant paclitaxel (50 mg/m\^2 IV) / carboplatin (AUC 2) IV chemotherapy + radiotherapy (41.4 Gy radiotherapy given over 23 fractions) before surgery. Subjects could receive an additional dose of durvalumab after completion of chemoradiation.
In Cohort D2, subjects continued durvalumab for 3 additional doses while receiving chemoradiation. Subjects were to undergo surgery 6 to 8 weeks after completing chemo(radio)therapy or according to institutional policies for surgery; and would be eligible to resume durvalumab dosing (to a maximum of 12 infusions) once recovered from surgery, provided that this was within 3 months of surgery.
Durvalumab: Anti PD-L1 antibody
Radiotherapy
Paclitaxel: IV administered chemotherapy
Carboplatin: IV administered chemotherapy
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
41.7%
5/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
20.0%
1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
19.0%
4/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
33.3%
3/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
33.3%
5/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Blood and lymphatic system disorders
Neutropenia
|
25.0%
3/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
20.0%
1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
14.3%
3/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
22.2%
2/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
20.0%
3/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
4/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
20.0%
1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
14.3%
3/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
13.3%
2/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Ear and labyrinth disorders
Ear pain
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
20.0%
1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Endocrine disorders
Hypothyroidism
|
16.7%
2/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
20.0%
1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Eye disorders
Blepharospasm
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Eye disorders
Dry eye
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Eye disorders
Eye pain
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Eye disorders
Vision blurred
|
16.7%
2/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.5%
2/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
40.0%
2/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.5%
2/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Abdominal distention
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
4/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
20.0%
1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
14.3%
3/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
13.3%
2/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
18.2%
2/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
13.3%
2/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Constipation
|
41.7%
5/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
80.0%
4/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
23.8%
5/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
44.4%
4/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
33.3%
5/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Diarrhoea
|
58.3%
7/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
40.0%
2/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
52.4%
11/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
45.5%
5/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
77.8%
7/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
66.7%
10/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
20.0%
1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
22.2%
2/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
26.7%
4/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Dysphagia
|
25.0%
3/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
60.0%
3/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
19.0%
4/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
33.3%
3/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
20.0%
3/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
16.7%
2/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Eructation
|
16.7%
2/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
36.4%
4/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
33.3%
3/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
20.0%
3/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
20.0%
1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Mouth ulceration
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Nausea
|
83.3%
10/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
80.0%
4/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
57.1%
12/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
45.5%
5/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
55.6%
5/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
60.0%
9/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Lip pruritus
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Malabsorption
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Retching
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Oesophageal fistula
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
22.2%
2/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
33.3%
5/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Sensitivity of teeth
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
20.0%
1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
20.0%
1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Vomiting
|
91.7%
11/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
40.0%
2/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
38.1%
8/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
33.3%
3/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
40.0%
6/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Steatorrhoea
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Tongue coated
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
General disorders
Asthenia
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
20.0%
1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
General disorders
Chest discomfort
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
20.0%
1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
General disorders
Chest pain
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
14.3%
3/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
13.3%
2/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
General disorders
Early satiety
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
20.0%
1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
General disorders
Chills
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
General disorders
Fatigue
|
83.3%
10/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
100.0%
5/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
61.9%
13/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
63.6%
7/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
66.7%
6/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
53.3%
8/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
General disorders
Influenza like illness
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
20.0%
1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.5%
2/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.5%
2/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
General disorders
Oedema peripheral
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
General disorders
Feeling cold
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
General disorders
Infusion site reaction
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
20.0%
1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
General disorders
Pain
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
20.0%
1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
General disorders
Peripheral swelling
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
General disorders
Pyrexia
|
16.7%
2/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
40.0%
2/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
22.2%
2/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
General disorders
Temperature intolerance
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.5%
2/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
27.3%
3/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Infections and infestations
Balanitis candida
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Infections and infestations
Cellulitis
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
19.0%
4/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Infections and infestations
Cystitis
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Infections and infestations
Influenza
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Infections and infestations
Localised infection
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Infections and infestations
Nail infection
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Infections and infestations
Oral candidiasis
|
25.0%
3/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
22.2%
2/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
13.3%
2/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Infections and infestations
Medical device site infection
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
18.2%
2/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.5%
2/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
40.0%
2/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Infections and infestations
Skin infection
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
14.3%
3/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
13.3%
2/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
20.0%
1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
18.2%
2/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Injury, poisoning and procedural complications
Contusion
|
16.7%
2/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Injury, poisoning and procedural complications
Wound complication
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Injury, poisoning and procedural complications
Dumping syndrome
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
20.0%
3/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
19.0%
4/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Investigations
Amylase increased
|
25.0%
3/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
20.0%
1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.5%
2/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
23.8%
5/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Investigations
Blood alkaline phosphatase increased
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.5%
2/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Investigations
Blood iron decreased
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Investigations
Blood urea increased
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
22.2%
2/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Investigations
Lipase increased
|
50.0%
6/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Investigations
Platelet count decreased
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.5%
2/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Investigations
Transaminases increased
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Investigations
Weight decreased
|
16.7%
2/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
60.0%
3/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
19.0%
4/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
18.2%
2/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
26.7%
4/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
2/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
60.0%
3/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
14.3%
3/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
18.2%
2/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
55.6%
5/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
33.3%
5/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
20.0%
1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.7%
2/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
20.0%
1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
22.2%
2/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
20.0%
3/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.5%
2/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
22.2%
2/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
22.2%
2/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
13.3%
2/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.5%
2/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
3/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.5%
2/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Jaw disorder
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
20.0%
1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.5%
2/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
22.2%
2/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
2/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
40.0%
2/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
19.0%
4/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
27.3%
3/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
20.0%
3/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
13.3%
2/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
20.0%
1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
13.3%
2/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Nervous system disorders
Dysaesthesia
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
14.3%
3/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Nervous system disorders
Dysgeusia
|
33.3%
4/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
18.2%
2/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
33.3%
3/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Nervous system disorders
Encephalitis autoimmune
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
20.0%
1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.5%
2/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
13.3%
2/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Nervous system disorders
Muscle contractions involuntary
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Nervous system disorders
Neuropathy peripheral
|
25.0%
3/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
40.0%
2/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
28.6%
6/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
54.5%
6/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
44.4%
4/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Nervous system disorders
Paraesthesia
|
25.0%
3/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
20.0%
1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
14.3%
3/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
27.3%
3/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
4/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
20.0%
1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
23.8%
5/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Nervous system disorders
Presyncope
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Nervous system disorders
Tremor
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Nervous system disorders
Poor quality sleep
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Nervous system disorders
Syncope
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
18.2%
2/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
40.0%
2/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Psychiatric disorders
Depression
|
16.7%
2/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Psychiatric disorders
Insomnia
|
25.0%
3/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
20.0%
1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
13.3%
2/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
4/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
40.0%
2/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
19.0%
4/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
54.5%
6/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
22.2%
2/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
33.3%
5/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
13.3%
2/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
40.0%
2/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
20.0%
1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
20.0%
1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.5%
2/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Dermatitis psoriasiform
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
2/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
20.0%
1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
20.0%
1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
23.8%
5/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
23.8%
5/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
18.2%
2/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
13.3%
2/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalized
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.5%
2/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
20.0%
1/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
14.3%
3/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
44.4%
4/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
33.3%
5/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Systemic lupus erythematosus rash
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.1%
1/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.5%
2/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Vascular disorders
Hypotension
|
8.3%
1/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
9.5%
2/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Vascular disorders
Flushing
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
6.7%
1/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Infections and infestations
Wound infection
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
11.1%
1/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.00%
0/12 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/5 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
4.8%
1/21 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/11 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/9 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
0.00%
0/15 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 110 days after the last dose of study treatment, up 18 months) were documented, regardless of a causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). All cause mortality included all deaths which were reported up to 3 years.
AE documentation included onset/resolution dates, severity using NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment and outcome. Preferred terms were counted once per subject at the maximum reported grade.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place