Trial Outcomes & Findings for A Phase I Trial of AZD3965 in Patients With Advanced Cancer (NCT NCT01791595)
NCT ID: NCT01791595
Last Updated: 2022-04-11
Results Overview
MTD was determined by testing increasing AZD3965 doses in Part 1 dose escalation cohorts (Cohorts 1-6) and defined as the total daily dose level below that at which ≥2 out of ≤6 evaluable patients had a dose-limiting toxicity (DLT) during Cycle 1 (including Day -7). DLTs were defined as highly probably/probably AZD3965 related haematological, cardiac, ophthalmic, other Grade 3/4 toxicity, death or drug-related toxicity causing AZD3965 interruption \>2 weeks (see protocol for specific criteria)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
53 participants
Primary outcome timeframe
Day -7 to Day 28
Results posted on
2022-04-11
Participant Flow
Trial participants were enrolled at seven trial sites between 23 April 2013 and 24 July 2019. Two additional patients were recruited to the trial but were withdrawn prior to receiving AZD3965.
Participant milestones
| Measure |
AZD3965 Cohort 1 (5 mg OD)
AZD3965: Day -7: single dose of 5 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 5 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 2 (10 mg OD)
AZD3965: Day -7: single dose of 10 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 3 (20 mg OD)
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 20 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 4 (30 mg OD)
AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 30 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 5 (15 mg BD)
AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 15 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 6 (10 mg BD)
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Expansion Cohort (10 mg BD)
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment (first 3 trial participants in the Expansion Cohort only; subsequent patients started treatment at Cycle 1, Day 1).
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
|---|---|---|---|---|---|---|---|
|
Part 1 AZD3965 Cohort 1 (5 mg OD)
STARTED
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1 AZD3965 Cohort 1 (5 mg OD)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1 AZD3965 Cohort 1 (5 mg OD)
NOT COMPLETED
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1 AZD3965 Cohort 2 (10 mg OD)
STARTED
|
0
|
5
|
0
|
0
|
0
|
0
|
0
|
|
Part 1 AZD3965 Cohort 2 (10 mg OD)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1 AZD3965 Cohort 2 (10 mg OD)
NOT COMPLETED
|
0
|
5
|
0
|
0
|
0
|
0
|
0
|
|
Part 1 AZD3965 Cohort 3 (20 mg OD)
STARTED
|
0
|
0
|
8
|
0
|
0
|
0
|
0
|
|
Part 1 AZD3965 Cohort 3 (20 mg OD)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1 AZD3965 Cohort 3 (20 mg OD)
NOT COMPLETED
|
0
|
0
|
8
|
0
|
0
|
0
|
0
|
|
Part 1 AZD3965 Cohort 4 (30 mg OD)
STARTED
|
0
|
0
|
0
|
5
|
0
|
0
|
0
|
|
Part 1 AZD3965 Cohort 4 (30 mg OD)
COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Part 1 AZD3965 Cohort 4 (30 mg OD)
NOT COMPLETED
|
0
|
0
|
0
|
4
|
0
|
0
|
0
|
|
Part 1 AZD3965 Cohort 5 (15 mg BD)
STARTED
|
0
|
0
|
0
|
0
|
11
|
0
|
0
|
|
Part 1 AZD3965 Cohort 5 (15 mg BD)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1 AZD3965 Cohort 5 (15 mg BD)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
11
|
0
|
0
|
|
Part 1 AZD3965 Cohort 6 (10 mg BD)
STARTED
|
0
|
0
|
0
|
0
|
0
|
8
|
0
|
|
Part 1 AZD3965 Cohort 6 (10 mg BD)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1 AZD3965 Cohort 6 (10 mg BD)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
8
|
0
|
|
Part 2 AZD3965 Expansion (10 mg BD)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
11
|
|
Part 2 AZD3965 Expansion (10 mg BD)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Part 2 AZD3965 Expansion (10 mg BD)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
10
|
Reasons for withdrawal
| Measure |
AZD3965 Cohort 1 (5 mg OD)
AZD3965: Day -7: single dose of 5 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 5 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 2 (10 mg OD)
AZD3965: Day -7: single dose of 10 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 3 (20 mg OD)
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 20 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 4 (30 mg OD)
AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 30 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 5 (15 mg BD)
AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 15 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 6 (10 mg BD)
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Expansion Cohort (10 mg BD)
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment (first 3 trial participants in the Expansion Cohort only; subsequent patients started treatment at Cycle 1, Day 1).
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
|---|---|---|---|---|---|---|---|
|
Part 1 AZD3965 Cohort 1 (5 mg OD)
Death
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1 AZD3965 Cohort 1 (5 mg OD)
Evidence of disease progression
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1 AZD3965 Cohort 2 (10 mg OD)
Evidence of disease progression
|
0
|
5
|
0
|
0
|
0
|
0
|
0
|
|
Part 1 AZD3965 Cohort 3 (20 mg OD)
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Part 1 AZD3965 Cohort 3 (20 mg OD)
Evidence of disease progression
|
0
|
0
|
6
|
0
|
0
|
0
|
0
|
|
Part 1 AZD3965 Cohort 3 (20 mg OD)
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Part 1 AZD3965 Cohort 4 (30 mg OD)
Adverse Event
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Part 1 AZD3965 Cohort 4 (30 mg OD)
Evidence of disease progression
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Part 1 AZD3965 Cohort 5 (15 mg BD)
Adverse Event
|
0
|
0
|
0
|
0
|
4
|
0
|
0
|
|
Part 1 AZD3965 Cohort 5 (15 mg BD)
Evidence of disease progression
|
0
|
0
|
0
|
0
|
5
|
0
|
0
|
|
Part 1 AZD3965 Cohort 5 (15 mg BD)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Part 1 AZD3965 Cohort 5 (15 mg BD)
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Part 1 AZD3965 Cohort 6 (10 mg BD)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
5
|
0
|
|
Part 1 AZD3965 Cohort 6 (10 mg BD)
Evidence of disease progression
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
|
Part 2 AZD3965 Expansion (10 mg BD)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Part 2 AZD3965 Expansion (10 mg BD)
Evidence of disease progression
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
|
Part 2 AZD3965 Expansion (10 mg BD)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Part 2 AZD3965 Expansion (10 mg BD)
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
AZD3965 Cohort 1 (5 mg OD)
n=3 Participants
AZD3965: Day -7: single dose of 5 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 5 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 2 (10 mg OD)
n=5 Participants
AZD3965: Day -7: single dose of 10 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 3 (20 mg OD)
n=8 Participants
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 20 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 4 (30 mg OD)
n=5 Participants
AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 30 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 5 (15 mg BD)
n=11 Participants
AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 15 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 6 (10 mg BD)
n=8 Participants
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Expansion Cohort (10 mg BD)
n=11 Participants
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment (first 3 trial participants in the Expansion Cohort only; subsequent patients started treatment at Cycle 1, Day 1).
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
62 years
n=3 Participants
|
66 years
n=5 Participants
|
64.5 years
n=8 Participants
|
72 years
n=5 Participants
|
63 years
n=11 Participants
|
63.5 years
n=8 Participants
|
70 years
n=11 Participants
|
65 years
n=51 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=3 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=11 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=11 Participants
|
19 Participants
n=51 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=3 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=8 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=11 Participants
|
7 Participants
n=8 Participants
|
7 Participants
n=11 Participants
|
32 Participants
n=51 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
3 participants
n=3 Participants
|
5 participants
n=5 Participants
|
8 participants
n=8 Participants
|
5 participants
n=5 Participants
|
11 participants
n=11 Participants
|
8 participants
n=8 Participants
|
11 participants
n=11 Participants
|
51 participants
n=51 Participants
|
PRIMARY outcome
Timeframe: Day -7 to Day 28Population: All patients recruited to dose escalation cohorts 1 to 6 who received at least one dose of AZD3965 (n=40)
MTD was determined by testing increasing AZD3965 doses in Part 1 dose escalation cohorts (Cohorts 1-6) and defined as the total daily dose level below that at which ≥2 out of ≤6 evaluable patients had a dose-limiting toxicity (DLT) during Cycle 1 (including Day -7). DLTs were defined as highly probably/probably AZD3965 related haematological, cardiac, ophthalmic, other Grade 3/4 toxicity, death or drug-related toxicity causing AZD3965 interruption \>2 weeks (see protocol for specific criteria)
Outcome measures
| Measure |
Part 1 Dose Escalation (Cohorts 1-6)
n=40 Participants
All eligible participants recruited to dose escalation cohorts 1 to 6 who received at least one dose of AZD3965.
|
AZD3965 Cohort 2 (10 mg OD)
AZD3965: Day -7: single dose of 10 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 3 (20 mg OD)
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 20 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 4 (30 mg OD)
AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 30 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 5 (15 mg BD)
AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 15 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 6 (10 mg BD)
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Expansion Cohort (10 mg BD)
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment (first 3 trial participants in the Expansion Cohort only; subsequent patients started treatment at Cycle 1, Day 1).
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
|---|---|---|---|---|---|---|---|
|
MTD of AZD3965
|
10 mg (twice daily)
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day -7 to Day 28Population: All recruited patients who received at least one dose of AZD3965 (N=51)
Number of patients who experienced protocol-defined DLTs (defined according to NCI CTCAE version 4.02). DLTs were defined as highly probably/probably AZD3965 related haematological, cardiac, ophthalmic, other Grade 3/4 toxicity, death or drug-related toxicity causing AZD3965 interruption \>2 weeks (see protocol for specific criteria)
Outcome measures
| Measure |
Part 1 Dose Escalation (Cohorts 1-6)
n=3 Participants
All eligible participants recruited to dose escalation cohorts 1 to 6 who received at least one dose of AZD3965.
|
AZD3965 Cohort 2 (10 mg OD)
n=5 Participants
AZD3965: Day -7: single dose of 10 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 3 (20 mg OD)
n=8 Participants
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 20 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 4 (30 mg OD)
n=5 Participants
AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 30 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 5 (15 mg BD)
n=11 Participants
AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 15 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 6 (10 mg BD)
n=8 Participants
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Expansion Cohort (10 mg BD)
n=11 Participants
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment (first 3 trial participants in the Expansion Cohort only; subsequent patients started treatment at Cycle 1, Day 1).
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
|---|---|---|---|---|---|---|---|
|
Number of Patients Who Experienced DLTs
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From the date of written informed consent and until 28 days after the last dose of AZD3965; an average (median) of 80 days (range: 36 to 517 days)Population: All recruited patients who received at least one dose of AZD3965 (N=51)
A serious adverse event (SAE) is any AE, regardless of dose, causality or expectedness, that results in death, is life-threatening, requires in-patient hospitalisation or prolongs existing in-patient hospitalisation, results in persistent or significant incapacity or disability, is a congenital anomaly or birth defect or is any other medically important event. Any ophthalmic and/or cardiac DLT is considered a medically important event and therefore an SAE in this trial. Specific AE terms are provided in the Adverse Events section
Outcome measures
| Measure |
Part 1 Dose Escalation (Cohorts 1-6)
n=3 Participants
All eligible participants recruited to dose escalation cohorts 1 to 6 who received at least one dose of AZD3965.
|
AZD3965 Cohort 2 (10 mg OD)
n=5 Participants
AZD3965: Day -7: single dose of 10 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 3 (20 mg OD)
n=8 Participants
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 20 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 4 (30 mg OD)
n=5 Participants
AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 30 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 5 (15 mg BD)
n=11 Participants
AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 15 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 6 (10 mg BD)
n=8 Participants
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Expansion Cohort (10 mg BD)
n=11 Participants
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment (first 3 trial participants in the Expansion Cohort only; subsequent patients started treatment at Cycle 1, Day 1).
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
|---|---|---|---|---|---|---|---|
|
Number of Patients Who Experienced Serious AEs
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
8 Participants
|
4 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: From the date of written informed consent and until 28 days after the last dose of AZD3965; an average (median) of 80 days (range: 36 to 517 days)Population: All recruited patients who received at least one dose of AZD3965 (N=51)
A non-serious AE is any untoward medical occurrence that does not meet the serious criteria described for outcome measure 3 above. Specific AE terms are provided in the Adverse Events section
Outcome measures
| Measure |
Part 1 Dose Escalation (Cohorts 1-6)
n=3 Participants
All eligible participants recruited to dose escalation cohorts 1 to 6 who received at least one dose of AZD3965.
|
AZD3965 Cohort 2 (10 mg OD)
n=5 Participants
AZD3965: Day -7: single dose of 10 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 3 (20 mg OD)
n=8 Participants
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 20 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 4 (30 mg OD)
n=5 Participants
AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 30 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 5 (15 mg BD)
n=11 Participants
AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 15 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 6 (10 mg BD)
n=8 Participants
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Expansion Cohort (10 mg BD)
n=11 Participants
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment (first 3 trial participants in the Expansion Cohort only; subsequent patients started treatment at Cycle 1, Day 1).
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
|---|---|---|---|---|---|---|---|
|
Number of Patients Who Experienced Non-Serious AEs
|
3 Participants
|
5 Participants
|
7 Participants
|
5 Participants
|
11 Participants
|
7 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Part 1 (Cohorts 1-4): Day -7 (pre-dose; 0.25, 0.5, 1, 2, 4, 6, 24, 48 hours post-dose) and Day 1 (pre-dose; 0.25, 0.5, 1, 2, 4, 6, 24 hours post-dose)Population: Part 1: Eligible patients who received AZD3965 on Day -7 and had a baseline and post-dose sample analysed (N=32; could only be calculated for N=5 in Cohort 6 \[N=6 for some PK parameters\]); Part 2: Eligible patients who received AZD3965 on Day 1 and had a baseline and post-dose sample analysed (N=11). Only calculated for Day -7 and Day 1 in Part 1 and not calculated for other timepoints due to low number of samples or for Part 2 due to limited number of sampling timepoints.
Plasma samples were analysed to determine the concentrations of AZD3965 using a previously developed liquid chromatography tandem mass spectrometry (LC-MS/MS) method. For twice daily dosing, Day -7 data reflect the full daily dose but subsequent timepoints reflect half the daily dose as PK sampling was conducted up to 12 hours following the first of the two daily doses; therefore, AUC is from 0 to 12 hours at those timepoints and is reported as a separate outcome measure.
Outcome measures
| Measure |
Part 1 Dose Escalation (Cohorts 1-6)
n=3 Participants
All eligible participants recruited to dose escalation cohorts 1 to 6 who received at least one dose of AZD3965.
|
AZD3965 Cohort 2 (10 mg OD)
n=5 Participants
AZD3965: Day -7: single dose of 10 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 3 (20 mg OD)
n=8 Participants
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 20 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 4 (30 mg OD)
n=5 Participants
AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 30 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 5 (15 mg BD)
n=6 Participants
AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 15 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 6 (10 mg BD)
n=5 Participants
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Expansion Cohort (10 mg BD)
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment (first 3 trial participants in the Expansion Cohort only; subsequent patients started treatment at Cycle 1, Day 1).
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-Time Curve (AUC) From 0 to 24 Hours Post AZD3965 Dosing
Day -7
|
211.7 h*ng/mL
Standard Deviation 84.9
|
730.8 h*ng/mL
Standard Deviation 311.4
|
1509.3 h*ng/mL
Standard Deviation 384.8
|
2843 h*ng/mL
Standard Deviation 1337.4
|
3984.7 h*ng/mL
Standard Deviation 2339.9
|
1540 h*ng/mL
Standard Deviation 693.6
|
—
|
|
Area Under the Concentration-Time Curve (AUC) From 0 to 24 Hours Post AZD3965 Dosing
Day 1
|
274 h*ng/mL
Standard Deviation 1
|
999 h*ng/mL
Standard Deviation 126.3
|
2123.5 h*ng/mL
Standard Deviation 589.6
|
3031 h*ng/mL
Standard Deviation 1360.5
|
NA h*ng/mL
Standard Deviation NA
For twice daily dosing, Day -7 data reflect the full daily dose but subsequent timepoints reflect half the daily dose as PK sampling was conducted up to 12 hours following the first of the two daily doses; therefore, AUC is from 0 to 12 hours at those timepoints and is reported as a separate outcome measure
|
NA h*ng/mL
Standard Deviation NA
For twice daily dosing, Day -7 data reflect the full daily dose but subsequent timepoints reflect half the daily dose as PK sampling was conducted up to 12 hours following the first of the two daily doses; therefore, AUC is from 0 to 12 hours at those timepoints and is reported as a separate outcome measure
|
—
|
SECONDARY outcome
Timeframe: Part 1 (Cohorts 5-6): Day 1 (pre-dose; 0.25, 0.5, 1, 2, 4, 6, 12 hours post-dose)Population: Part 1: Eligible patients who received AZD3965 on Day -7 and had a baseline and post-dose sample analysed (N=32; could only be calculated for N=5 in Cohort 6 \[N=6 for some PK parameters\]); Part 2: Eligible patients who received AZD3965 on Day 1 and had a baseline and post-dose sample analysed (N=11). Only calculated for Day -7 and Day 1 in Part 1 and not calculated for other timepoints due to low number of samples or for Part 2 due to limited number of sampling timepoints.
Plasma samples were analysed to determine the concentrations of AZD3965 using a previously developed LC-MS/MS method. AUC from 0 to 12 hours was applicable to twice daily dosing on Day 1 only. See AUC From 0 to 24 Hours Post AZD3965 Dosing for AUC for other cohorts and timepoints.
Outcome measures
| Measure |
Part 1 Dose Escalation (Cohorts 1-6)
n=6 Participants
All eligible participants recruited to dose escalation cohorts 1 to 6 who received at least one dose of AZD3965.
|
AZD3965 Cohort 2 (10 mg OD)
n=5 Participants
AZD3965: Day -7: single dose of 10 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 3 (20 mg OD)
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 20 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 4 (30 mg OD)
AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 30 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 5 (15 mg BD)
AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 15 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 6 (10 mg BD)
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Expansion Cohort (10 mg BD)
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment (first 3 trial participants in the Expansion Cohort only; subsequent patients started treatment at Cycle 1, Day 1).
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
|---|---|---|---|---|---|---|---|
|
AUC From 0 to 12 Hours Post AZD3965 Dosing
|
1251.5 h*ng/mL
Standard Deviation 654.2
|
620 h*ng/mL
Standard Deviation 272.2
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1 (Cohorts 1-6): Day -7 (pre-dose; 0.25, 0.5, 1, 2, 4, 6, 24, 48 hours post-dose), Day 1 & 29 (each pre-dose; 0.25, 0.5, 1, 2, 4, 6, 24 hours post-dose [12 hours post-dose if BD]); Part 2 (Expansion): Day 1 (pre-dose; 4, 6, 12 hours post-dose)Population: Part 1: Eligible patients who received AZD3965 on Day -7 and had a baseline and post-dose sample analysed (N=33) (Only limited samples were available at Day 29); Part 2: Eligible patients who received AZD3965 on Day 1 and had a baseline and post-dose sample analysed (in Part 2 of the trial, PK data were only collected for Day 1)
Plasma samples were analysed to determine the concentrations of AZD3965 using a previously developed LC-MS/MS method. For twice daily dosing, Day -7 data reflect the full daily dose and other timepoints reflect half the daily dose.
Outcome measures
| Measure |
Part 1 Dose Escalation (Cohorts 1-6)
n=3 Participants
All eligible participants recruited to dose escalation cohorts 1 to 6 who received at least one dose of AZD3965.
|
AZD3965 Cohort 2 (10 mg OD)
n=5 Participants
AZD3965: Day -7: single dose of 10 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 3 (20 mg OD)
n=8 Participants
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 20 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 4 (30 mg OD)
n=5 Participants
AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 30 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 5 (15 mg BD)
n=6 Participants
AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 15 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 6 (10 mg BD)
n=6 Participants
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Expansion Cohort (10 mg BD)
n=6 Participants
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment (first 3 trial participants in the Expansion Cohort only; subsequent patients started treatment at Cycle 1, Day 1).
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration of AZD3965
Day 1
|
38.4 ng/mL
Standard Deviation 9.5
|
135.0 ng/mL
Standard Deviation 53.2
|
219.9 ng/mL
Standard Deviation 62.1
|
458.4 ng/mL
Standard Deviation 237
|
213.6 ng/mL
Standard Deviation 122.1
|
106.2 ng/mL
Standard Deviation 57.1
|
78.5 ng/mL
Standard Deviation 42.3
|
|
Maximum Observed Plasma Concentration of AZD3965
Day -7
|
43.4 ng/mL
Standard Deviation 22
|
122 ng/mL
Standard Deviation 62.7
|
222.7 ng/mL
Standard Deviation 95.1
|
377.6 ng/mL
Standard Deviation 80.2
|
483.9 ng/mL
Standard Deviation 205.7
|
226 ng/mL
Standard Deviation 85.7
|
—
|
|
Maximum Observed Plasma Concentration of AZD3965
Day 29
|
48.6 ng/mL
Standard Deviation NA
Only one patient had evaluable data at this timepoint
|
271.6 ng/mL
Standard Deviation 123.3
|
310.1 ng/mL
Standard Deviation 180.6
|
239.2 ng/mL
Standard Deviation NA
Only one patient had evaluable data at this timepoint
|
—
|
132.3 ng/mL
Standard Deviation 38.6
|
—
|
SECONDARY outcome
Timeframe: Part 1 (Cohorts 1-6): Day -7 (pre-dose; 0.25, 0.5, 1, 2, 4, 6, 24, 48 hours post-dose) and Day 1 (pre-dose, 0.25, 0.5, 1, 2, 4, 6, 24 hours post-dose [12 hours post-dose if BD])Population: Part 1: Eligible patients who received AZD3965 on Day -7 and had a baseline and post-dose sample analysed (N=33); Part 2: Eligible patients who received AZD3965 on Day 1 and had a baseline and post-dose sample analysed (N=11). Only calculated for Day -7 and Day 1 in Part 1; not calculated for other timepoints due to low number of samples or for Part 2 due to number of sampling time points. One patient in Cohort 6 did not have Day -7 data (N=5).
Plasma samples were analysed to determine the concentrations of AZD3965 using a previously developed LC-MS/MS method. For twice daily dosing, Day -7 data reflect the full daily dose and other timepoints reflect half the daily dose.
Outcome measures
| Measure |
Part 1 Dose Escalation (Cohorts 1-6)
n=3 Participants
All eligible participants recruited to dose escalation cohorts 1 to 6 who received at least one dose of AZD3965.
|
AZD3965 Cohort 2 (10 mg OD)
n=5 Participants
AZD3965: Day -7: single dose of 10 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 3 (20 mg OD)
n=8 Participants
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 20 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 4 (30 mg OD)
n=5 Participants
AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 30 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 5 (15 mg BD)
n=6 Participants
AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 15 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 6 (10 mg BD)
n=6 Participants
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Expansion Cohort (10 mg BD)
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment (first 3 trial participants in the Expansion Cohort only; subsequent patients started treatment at Cycle 1, Day 1).
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
|---|---|---|---|---|---|---|---|
|
Time to Maximum Observed Concentration of AZD3965
Day -7
|
1.1 Hour
Interval 1.0 to 2.0
|
1.1 Hour
Interval 1.0 to 4.1
|
1 Hour
Interval 0.5 to 2.0
|
1.1 Hour
Interval 0.5 to 2.1
|
1.5 Hour
Interval 0.9 to 4.0
|
1.92 Hour
Interval 0.95 to 4.02
|
—
|
|
Time to Maximum Observed Concentration of AZD3965
Day 1
|
2 Hour
Interval 1.0 to 4.0
|
2 Hour
Interval 1.0 to 4.2
|
2.05 Hour
Interval 1.0 to 6.1
|
1.1 Hour
Interval 1.0 to 3.9
|
2 Hour
Interval 1.0 to 4.0
|
1.075 Hour
Interval 0.98 to 6.08
|
—
|
SECONDARY outcome
Timeframe: Part 1 (Cohorts 1-6): Day -7 (pre-dose; 0.25, 0.5, 1, 2, 4, 6, 24, 48 hours post-dose and Day 1 pre-dose (168 hours post Day -7 dose)Population: Part 1: Eligible patients who received AZD3965 on Day -7 and had a baseline and post-dose sample analysed (N=32; one patient had a reduced dose in Cohort 6 at Day -7 so these data are not included in half life calculation). Not calculated for Part 2 due to limited number of sampling timepoints.
Plasma samples were analysed to determine the concentrations of AZD3965 using a previously developed LC-MS/MS method.
Outcome measures
| Measure |
Part 1 Dose Escalation (Cohorts 1-6)
n=3 Participants
All eligible participants recruited to dose escalation cohorts 1 to 6 who received at least one dose of AZD3965.
|
AZD3965 Cohort 2 (10 mg OD)
n=5 Participants
AZD3965: Day -7: single dose of 10 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 3 (20 mg OD)
n=8 Participants
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 20 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 4 (30 mg OD)
n=5 Participants
AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 30 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 5 (15 mg BD)
n=6 Participants
AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 15 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 6 (10 mg BD)
n=5 Participants
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Expansion Cohort (10 mg BD)
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment (first 3 trial participants in the Expansion Cohort only; subsequent patients started treatment at Cycle 1, Day 1).
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
|---|---|---|---|---|---|---|---|
|
Elimination Half Life for AZD3965
|
51.9 Hour
Standard Deviation 4.9
|
45.4 Hour
Standard Deviation 6.4
|
38.3 Hour
Standard Deviation 5.9
|
38.7 Hour
Standard Deviation 13.3
|
37.5 Hour
Standard Deviation 8.5
|
33.6 Hour
Standard Deviation 4.3
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -14 to -8), Day -7 (pre-dose) Day 1 (24 hours post-dose), Day 8 (pre-dose), Day 29 (pre-dose)Population: All patients in Part 1 who received AZD3965 and provided pre and post-treatment blood samples (N=37). Some patients did not have data at all timepoints
Plasma samples were analysed to determine the level of M30 using a validated cell death ELISA in Part 1 (Cohorts 1-6). Assays not conducted for Part 2 of the trial as considered uninformative.
Outcome measures
| Measure |
Part 1 Dose Escalation (Cohorts 1-6)
n=3 Participants
All eligible participants recruited to dose escalation cohorts 1 to 6 who received at least one dose of AZD3965.
|
AZD3965 Cohort 2 (10 mg OD)
n=5 Participants
AZD3965: Day -7: single dose of 10 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 3 (20 mg OD)
n=8 Participants
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 20 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 4 (30 mg OD)
n=5 Participants
AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 30 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 5 (15 mg BD)
n=11 Participants
AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 15 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 6 (10 mg BD)
n=5 Participants
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Expansion Cohort (10 mg BD)
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment (first 3 trial participants in the Expansion Cohort only; subsequent patients started treatment at Cycle 1, Day 1).
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
|---|---|---|---|---|---|---|---|
|
Plasma Level of Cell Death Marker M30 (Caspase-Cleaved CK18; Part 1 Only)
Baseline
|
383 U/L
Standard Deviation NA
Only one patient had evaluable data at this timepoint
|
944.8 U/L
Standard Deviation 72.6
|
392.3 U/L
Standard Deviation 300.3
|
196.0 U/L
Standard Deviation 96.3
|
464.9 U/L
Standard Deviation 304.9
|
359.6 U/L
Standard Deviation 364
|
—
|
|
Plasma Level of Cell Death Marker M30 (Caspase-Cleaved CK18; Part 1 Only)
Day -7
|
201 U/L
Standard Deviation 17
|
865.6 U/L
Standard Deviation 250.3
|
410.1 U/L
Standard Deviation 296.5
|
225.6 U/L
Standard Deviation 114.5
|
464.8 U/L
Standard Deviation 312.3
|
342 U/L
Standard Deviation 371.9
|
—
|
|
Plasma Level of Cell Death Marker M30 (Caspase-Cleaved CK18; Part 1 Only)
Day 1
|
174.5 U/L
Standard Deviation 60.1
|
860.6 U/L
Standard Deviation 191.5
|
428.4 U/L
Standard Deviation 302.9
|
220.6 U/L
Standard Deviation 112.7
|
487.9 U/L
Standard Deviation 326.9
|
336.6 U/L
Standard Deviation 375.9
|
—
|
|
Plasma Level of Cell Death Marker M30 (Caspase-Cleaved CK18; Part 1 Only)
Day 8
|
226 U/L
Standard Deviation 86.2
|
959.4 U/L
Standard Deviation 90.8
|
457.1 U/L
Standard Deviation 339.5
|
206.8 U/L
Standard Deviation 90.2
|
418.6 U/L
Standard Deviation 327.8
|
343.4 U/L
Standard Deviation 370.8
|
—
|
|
Plasma Level of Cell Death Marker M30 (Caspase-Cleaved CK18; Part 1 Only)
Day 29
|
176 U/L
Standard Deviation 46.7
|
836.7 U/L
Standard Deviation 282.9
|
428 U/L
Standard Deviation 366.6
|
267.8 U/L
Standard Deviation 157.8
|
660.3 U/L
Standard Deviation 489.7
|
344.6 U/L
Standard Deviation 369.5
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -14 to -8), Day -7 (pre-dose) Day 1 (24 hours post-dose), Day 8 (pre-dose), Day 29 (pre-dose)Population: All patients in Part 1 who received AZD3965 and provided pre and post-treatment blood samples (N=37). Some patients did not have data at all timepoints
Plasma samples were analysed to determine the level of M65 using a validated cell death enzyme-linked immunosorbent assay (ELISA) in Part 1 (Cohorts 1-6). Assays not conducted for Part 2 of the trial as considered uninformative.
Outcome measures
| Measure |
Part 1 Dose Escalation (Cohorts 1-6)
n=3 Participants
All eligible participants recruited to dose escalation cohorts 1 to 6 who received at least one dose of AZD3965.
|
AZD3965 Cohort 2 (10 mg OD)
n=5 Participants
AZD3965: Day -7: single dose of 10 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 3 (20 mg OD)
n=8 Participants
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 20 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 4 (30 mg OD)
n=5 Participants
AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 30 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 5 (15 mg BD)
n=11 Participants
AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 15 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 6 (10 mg BD)
n=5 Participants
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Expansion Cohort (10 mg BD)
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment (first 3 trial participants in the Expansion Cohort only; subsequent patients started treatment at Cycle 1, Day 1).
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
|---|---|---|---|---|---|---|---|
|
Plasma Level of Cell Death Marker M65 (Total Plus Caspase-Cleaved CK18; Part 1 Only)
Day 1
|
469.0 U/L
Standard Deviation 12.7
|
3935.6 U/L
Standard Deviation 1522.0
|
1742.0 U/L
Standard Deviation 1840.9
|
981.0 U/L
Standard Deviation 1054.8
|
1673.0 U/L
Standard Deviation 1450.2
|
255.4 U/L
Standard Deviation 157.3
|
—
|
|
Plasma Level of Cell Death Marker M65 (Total Plus Caspase-Cleaved CK18; Part 1 Only)
Baseline
|
533.0 U/L
Standard Deviation NA
Only one patient had evaluable data at this timepoint
|
4496.0 U/L
Standard Deviation 1008.0
|
1602.1 U/L
Standard Deviation 1627.4
|
1046.6 U/L
Standard Deviation 1338.7
|
1344.3 U/L
Standard Deviation 1202.5
|
287.6 U/L
Standard Deviation 192.2
|
—
|
|
Plasma Level of Cell Death Marker M65 (Total Plus Caspase-Cleaved CK18; Part 1 Only)
Day -7
|
623.5 U/L
Standard Deviation 446.2
|
3846.4 U/L
Standard Deviation 1772.5
|
1796.4 U/L
Standard Deviation 1697.6
|
935.6 U/L
Standard Deviation 1000.7
|
1488.7 U/L
Standard Deviation 1409.6
|
233.2 U/L
Standard Deviation 126.9
|
—
|
|
Plasma Level of Cell Death Marker M65 (Total Plus Caspase-Cleaved CK18; Part 1 Only)
Day 8
|
841.3 U/L
Standard Deviation 651.4
|
4478.4 U/L
Standard Deviation 730.2
|
1807.0 U/L
Standard Deviation 2072.6
|
474.2 U/L
Standard Deviation 568.5
|
1418.4 U/L
Standard Deviation 1472.6
|
252.0 U/L
Standard Deviation 155.1
|
—
|
|
Plasma Level of Cell Death Marker M65 (Total Plus Caspase-Cleaved CK18; Part 1 Only)
Day 29
|
801.5 U/L
Standard Deviation 314.7
|
5000.0 U/L
Standard Deviation 0.0
|
1226.8 U/L
Standard Deviation 2123.2
|
443.0 U/L
Standard Deviation 566.5
|
2609.3 U/L
Standard Deviation 2452.2
|
285.0 U/L
Standard Deviation 172.3
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -14 to -8), Day -7 (pre-dose) Day 1 (24 hours post-dose), Day 8 (pre-dose), Day 29 (pre-dose)Population: All patients in Part 1 who received AZD3965 and provided pre and post-treatment blood samples (N=37). Some patients did not have data at all timepoints
Plasma samples were analysed to determine the level of nDNA using validated methodology in Part 1 (Cohorts 1-6). Assays not conducted for Part 2 of the trial as considered uninformative.
Outcome measures
| Measure |
Part 1 Dose Escalation (Cohorts 1-6)
n=3 Participants
All eligible participants recruited to dose escalation cohorts 1 to 6 who received at least one dose of AZD3965.
|
AZD3965 Cohort 2 (10 mg OD)
n=5 Participants
AZD3965: Day -7: single dose of 10 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 3 (20 mg OD)
n=8 Participants
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 20 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 4 (30 mg OD)
n=5 Participants
AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 30 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 5 (15 mg BD)
n=11 Participants
AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 15 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 6 (10 mg BD)
n=5 Participants
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Expansion Cohort (10 mg BD)
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment (first 3 trial participants in the Expansion Cohort only; subsequent patients started treatment at Cycle 1, Day 1).
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
|---|---|---|---|---|---|---|---|
|
Plasma Level of Nucleosomal DNA (nDNA) as a Measure of Apoptosis (Part 1 Only)
Baseline
|
0.123 Optical density
Standard Deviation NA
Only one patient had evaluable data at this timepoint
|
0.778 Optical density
Standard Deviation 1.144
|
0.614 Optical density
Standard Deviation 0.865
|
0.170 Optical density
Standard Deviation 0.138
|
0.485 Optical density
Standard Deviation 0.879
|
0.139 Optical density
Standard Deviation 0.134
|
—
|
|
Plasma Level of Nucleosomal DNA (nDNA) as a Measure of Apoptosis (Part 1 Only)
Day -7
|
0.450 Optical density
Standard Deviation 0.180
|
0.731 Optical density
Standard Deviation 0.860
|
0.580 Optical density
Standard Deviation 0.889
|
0.204 Optical density
Standard Deviation 0.187
|
0.259 Optical density
Standard Deviation 0.257
|
0.140 Optical density
Standard Deviation 0.158
|
—
|
|
Plasma Level of Nucleosomal DNA (nDNA) as a Measure of Apoptosis (Part 1 Only)
Day 1
|
0.397 Optical density
Standard Deviation 0.372
|
0.924 Optical density
Standard Deviation 1.114
|
0.593 Optical density
Standard Deviation 0.796
|
0.200 Optical density
Standard Deviation 0.186
|
0.241 Optical density
Standard Deviation 0.191
|
0.140 Optical density
Standard Deviation 0.146
|
—
|
|
Plasma Level of Nucleosomal DNA (nDNA) as a Measure of Apoptosis (Part 1 Only)
Day 8
|
0.441 Optical density
Standard Deviation 0.280
|
1.111 Optical density
Standard Deviation 1.059
|
0.697 Optical density
Standard Deviation 1.033
|
0.206 Optical density
Standard Deviation 0.135
|
0.287 Optical density
Standard Deviation 0.305
|
0.149 Optical density
Standard Deviation 0.136
|
—
|
|
Plasma Level of Nucleosomal DNA (nDNA) as a Measure of Apoptosis (Part 1 Only)
Day 29
|
0.298 Optical density
Standard Deviation 0.270
|
1.060 Optical density
Standard Deviation 0.538
|
0.841 Optical density
Standard Deviation 1.208
|
0.144 Optical density
Standard Deviation 0.116
|
0.195 Optical density
Standard Deviation 0.179
|
0.156 Optical density
Standard Deviation 0.144
|
—
|
SECONDARY outcome
Timeframe: Radiological disease assessment at screening/baseline and every 6 weeks to end of treatment; an average (median) of 44 days (range: 36 to 432 days)Population: Part 2: All patients who met the eligibility criteria, received at least 75% of their first continuous treatment cycle (28 days) and had a baseline assessment of disease (N=5)
Antitumour activity measured according to RECIST version 1.1 (solid tumours)(see Eishenhauer et al; Eur J Cancer 2009, 45:228-247) or IWG criteria for Lymphoma (lymphoma)(see Cheson, Fisher et al; JCO 2014, 32:3059-3067). Complete or partial response/remission was confirmed by repeat measurements ≥4 weeks after response criteria were met; patients with stable disease met criteria at least once ≥6 weeks after first dose of AZD3965
Outcome measures
| Measure |
Part 1 Dose Escalation (Cohorts 1-6)
n=5 Participants
All eligible participants recruited to dose escalation cohorts 1 to 6 who received at least one dose of AZD3965.
|
AZD3965 Cohort 2 (10 mg OD)
AZD3965: Day -7: single dose of 10 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 3 (20 mg OD)
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 20 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 4 (30 mg OD)
AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 30 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 5 (15 mg BD)
AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 15 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 6 (10 mg BD)
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Expansion Cohort (10 mg BD)
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment (first 3 trial participants in the Expansion Cohort only; subsequent patients started treatment at Cycle 1, Day 1).
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
|---|---|---|---|---|---|---|---|
|
Number of Patients Who Experienced a Complete Response, Partial Response or Stable Disease According to RECIST 1.1 or a Complete Remission, Partial Remission or Stable Disease According to the IWG Criteria for Lymphoma (Part 2 Only)
Stable disease
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients Who Experienced a Complete Response, Partial Response or Stable Disease According to RECIST 1.1 or a Complete Remission, Partial Remission or Stable Disease According to the IWG Criteria for Lymphoma (Part 2 Only)
Complete remission
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
AZD3965 Cohort 1 (5 mg OD)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
AZD3965 Cohort 2 (10 mg OD)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 1 deaths
AZD3965 Cohort 3 (20 mg OD)
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
AZD3965 Cohort 4 (30 mg OD)
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
AZD3965 Cohort 5 (15 mg BD)
Serious events: 8 serious events
Other events: 11 other events
Deaths: 0 deaths
AZD3965 Cohort 6 (10 mg BD)
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
AZD3965 Expansion Cohort (10 mg BD)
Serious events: 8 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AZD3965 Cohort 1 (5 mg OD)
n=3 participants at risk
AZD3965: Day -7: single dose of 5 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 5 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 2 (10 mg OD)
n=5 participants at risk
AZD3965: Day -7: single dose of 10 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 3 (20 mg OD)
n=8 participants at risk
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 20 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 4 (30 mg OD)
n=5 participants at risk
AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 30 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 5 (15 mg BD)
n=11 participants at risk
AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 15 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 6 (10 mg BD)
n=8 participants at risk
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Expansion Cohort (10 mg BD)
n=11 participants at risk
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment (first 3 trial participants in the Expansion Cohort only; subsequent patients started treatment at Cycle 1, Day 1).
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles.
Patients benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
|---|---|---|---|---|---|---|---|
|
General disorders
Ulcer
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Investigations
Cardiac troponin I increased
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Investigations
Cardiac troponin T increased
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
General disorders
Chills
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
General disorders
Death NOS
|
33.3%
1/3 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
25.0%
2/8 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
General disorders
Fatigue
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
General disorders
Fever
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Infections and infestations
Infection
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Infections and infestations
Infective exacerbation of bronchiectasis
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
General disorders
Infusion related reaction
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract infection
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
25.0%
2/8 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
General disorders
Pain
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Vascular disorders
Pulmonary embolism
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Eye disorders
Retinopathy
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
18.2%
2/11 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Investigations
Troponin I increased
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
Other adverse events
| Measure |
AZD3965 Cohort 1 (5 mg OD)
n=3 participants at risk
AZD3965: Day -7: single dose of 5 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 5 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 2 (10 mg OD)
n=5 participants at risk
AZD3965: Day -7: single dose of 10 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 3 (20 mg OD)
n=8 participants at risk
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 20 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 4 (30 mg OD)
n=5 participants at risk
AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 30 mg AZD3965 OD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 5 (15 mg BD)
n=11 participants at risk
AZD3965: Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 15 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Cohort 6 (10 mg BD)
n=8 participants at risk
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment.
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles.
Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
AZD3965 Expansion Cohort (10 mg BD)
n=11 participants at risk
AZD3965: Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment (first 3 trial participants in the Expansion Cohort only; subsequent patients started treatment at Cycle 1, Day 1).
Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles.
Patients benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Psychiatric disorders
Anxiety
|
33.3%
1/3 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
25.0%
2/8 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
36.4%
4/11 • Number of events 4 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Infections and infestations
H3N2 influenza
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Investigations
Retinogram abnormal
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Eye disorders
Retinopathy
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
25.0%
2/8 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
100.0%
5/5 • Number of events 7 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
36.4%
4/11 • Number of events 6 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
25.0%
2/8 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Infections and infestations
Rhinitis infective
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Investigations
Cardiac troponin I increased
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Investigations
Cardiac troponin T increased
|
33.3%
1/3 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
60.0%
3/5 • Number of events 4 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Investigations
Alanine aminotransferase increased
|
66.7%
2/3 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
25.0%
2/8 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
18.2%
2/11 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Investigations
Alkaline phosphatase increased
|
33.3%
1/3 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
40.0%
2/5 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
37.5%
3/8 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
25.0%
2/8 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
60.0%
3/5 • Number of events 4 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
37.5%
3/8 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
40.0%
2/5 • Number of events 6 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
36.4%
4/11 • Number of events 4 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
1/3 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
60.0%
3/5 • Number of events 4 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
25.0%
2/8 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
40.0%
2/5 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
36.4%
4/11 • Number of events 4 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
37.5%
3/8 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Investigations
Aspartate aminotransferase increased
|
66.7%
2/3 • Number of events 4 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
40.0%
2/5 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
37.5%
3/8 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Nervous system disorders
Ataxia
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Eye disorders
Blindness transient
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
66.7%
2/3 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
40.0%
2/5 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Investigations
Blood bilirubin increased
|
66.7%
2/3 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Eye disorders
Blurred vision
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
40.0%
2/5 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
33.3%
1/3 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Infections and infestations
Candida infection
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
27.3%
3/11 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Eye disorders
Cataract
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Cardiac disorders
Chest pain
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
18.2%
2/11 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
33.3%
1/3 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Nervous system disorders
Concentration impairment
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
18.2%
2/11 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Gastrointestinal disorders
Constipation
|
100.0%
3/3 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
37.5%
3/8 • Number of events 4 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
40.0%
2/5 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
36.4%
4/11 • Number of events 4 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
25.0%
2/8 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
18.2%
2/11 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
27.3%
3/11 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Investigations
Creatinine increased
|
33.3%
1/3 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
General disorders
Cyst
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
27.3%
3/11 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Psychiatric disorders
Depression
|
33.3%
1/3 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Product Issues
Device occlusion
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
36.4%
4/11 • Number of events 4 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
27.3%
3/11 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
18.2%
2/11 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Gastrointestinal disorders
Dysphagia
|
33.3%
1/3 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
40.0%
2/5 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
18.2%
2/11 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Eye disorders
Ear pain
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
General disorders
Edema limbs
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
40.0%
2/5 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
25.0%
2/8 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
40.0%
2/5 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Eye disorders
Eye inflammation
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
General disorders
Facial pain
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
General disorders
Fatigue
|
66.7%
2/3 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
80.0%
4/5 • Number of events 4 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
25.0%
2/8 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
27.3%
3/11 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
62.5%
5/8 • Number of events 5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
45.5%
5/11 • Number of events 5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
General disorders
Fever
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
General disorders
Flu like symptoms
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Reproductive system and breast disorders
Genitals enlarged
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
18.2%
2/11 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
25.0%
2/8 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
33.3%
1/3 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
18.2%
2/11 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
27.3%
3/11 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Metabolism and nutrition disorders
Hyponatremia
|
33.3%
1/3 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
60.0%
3/5 • Number of events 4 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
27.3%
3/11 • Number of events 4 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
36.4%
4/11 • Number of events 5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Investigations
Investigations - Other, specify
|
66.7%
2/3 • Number of events 5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
40.0%
2/5 • Number of events 5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Infections and infestations
Lip infection
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Infections and infestations
Localised infection
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
General disorders
Malaise
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
66.7%
2/3 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
25.0%
2/8 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
18.2%
2/11 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Infections and infestations
Moraxella infection
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Nervous system disorders
Movements involuntary
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Gastrointestinal disorders
Mucositis oral
|
33.3%
1/3 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
18.2%
2/11 • Number of events 4 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
18.2%
2/11 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
18.2%
2/11 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Gastrointestinal disorders
Nausea
|
100.0%
3/3 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
80.0%
4/5 • Number of events 5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
40.0%
2/5 • Number of events 4 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
27.3%
3/11 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
27.3%
3/11 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
18.2%
2/11 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
45.5%
5/11 • Number of events 6 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Eye disorders
Optic nerve disorder
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Infections and infestations
Oral herpes
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
General disorders
Pain
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
18.2%
2/11 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
25.0%
2/8 • Number of events 4 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
18.2%
2/11 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
General disorders
Performance status decreased
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
27.3%
3/11 • Number of events 5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Eye disorders
Retinal vascular disorder
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
37.5%
3/8 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
25.0%
2/8 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
27.3%
3/11 • Number of events 4 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
12.5%
1/8 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Renal and urinary disorders
Urine discoloration
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
33.3%
1/3 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
18.2%
2/11 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
2/3 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
40.0%
2/5 • Number of events 4 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
36.4%
4/11 • Number of events 4 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
25.0%
2/8 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
18.2%
2/11 • Number of events 2 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Eye disorders
Watering eyes
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Investigations
Weight increased
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Investigations
Weight loss
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
20.0%
1/5 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/5 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
9.1%
1/11 • Number of events 1 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/8 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
0.00%
0/11 • Safety data was collected from the date of written informed consent and continued until 28 days after the last dose of AZD3965, an average (median) of 80 days (range: 36-517).
AE terms from vocabulary, NCI CTCAE V4.02 for Part 1 (AZD3965 Cohorts 1-6) and MedDRA V23.0 for Part 2 (Expansion Cohort)
|
Additional Information
Regulatory Affairs Manager
Cancer Research UK Centre for Drug Development
Phone: +44 203 4696878
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place